Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-02-26 @ 3:15 AM
Study NCT ID:
NCT04796935
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2021-03-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D011559', 'term': 'Pseudotumor Cerebri'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D051299', 'term': 'Post-Dural Puncture Headache'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D019586', 'term': 'Intracranial Hypertension'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kurwin@elevateclinicalconsulting.com', 'phone': '919-247-8845', 'title': 'Keri Urwin', 'organization': 'Elevate Clinical Consulting'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "The enrollment period (April 2021-November 2021) was closed due to COVID concerns prior to reaching 96 evaluable subjects. Due to limitations in the emergency medicine setting at one site, emergency medicine providers at that site performed procedures for approximately half of the subjects enrolled in that site's neurology setting. Due to scheduling limitations, only MDs (including residents) performed procedures, and not all providers had the opportunity to use the device more than once."}}, 'adverseEventsModule': {'timeFrame': '3±2 days', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 2, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 1, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Syncope', 'notes': 'VerTouch Group: determined unlikely to be related to device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhage', 'notes': 'VerTouch Group: determined unrelated to device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back and Shoulder Pain', 'notes': 'Palpation Arm: may have been related to study procedure but not study device (control group)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Insertion Attempts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.'}, {'id': 'OG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.'}], 'classes': [{'title': 'ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '2.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of procedure, 1 per participant', 'description': 'Any forward movement of the needle following puncture of the skin, counted until confirmation of spinal canal access can be assessed.', 'unitOfMeasure': 'insertions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) includes all randomized subjects. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success. Number analyzed in each population refers to the subjects with data collected for the specific outcome measure.'}, {'type': 'SECONDARY', 'title': 'Incidence of First-insertion Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.'}, {'id': 'OG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.'}], 'classes': [{'title': 'ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'A case that does not require any reinsertions, but can include any number of redirections.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT includes all randomized subjects. PP excludes subjects that did not receive the randomized method and/or achieve a procedure success. Number analyzed in each population refers to the subjects with data recorded for the related outcome measure (insertions).'}, {'type': 'SECONDARY', 'title': 'Number of Redirections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.'}, {'id': 'OG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.'}], 'classes': [{'title': 'ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '5.60', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '8.44', 'groupId': 'OG001'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '3.14', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '8.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'Any forward movement of the needle in a new direction not preceded by withdrawal from the skin, counted until confirmation of spinal canal access can be assessed.', 'unitOfMeasure': 'redirections', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT includes all randomized subjects. PP excludes subjects that did not receive the randomized method and/or achieve a procedure success. Number analyzed in each population refers to the subjects with data collected for the specific outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Passes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.'}, {'id': 'OG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.'}], 'classes': [{'title': 'ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '6.66', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '9.78', 'groupId': 'OG001'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '3.49', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '9.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'Any forward movement of the needle, calculated as the sum of insertions and redirections.', 'unitOfMeasure': 'passes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT includes all randomized subjects. PP excludes subjects that did not receive the randomized method and/or achieve a procedure success. Number analyzed in each population refers to the subjects with data collected for the related outcome measures (insertions and redirections).'}, {'type': 'SECONDARY', 'title': 'Incidence of First-pass Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.'}, {'id': 'OG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.'}], 'classes': [{'title': 'ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'A case that does not require reinsertions or redirections.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT includes all randomized subjects. PP excludes subjects that did not receive the randomized method and/or achieve a procedure success. Number analyzed in each population refers to the subjects with data collected for the related outcome measures (insertions, redirections).'}, {'type': 'SECONDARY', 'title': 'Subject Discomfort During Landmarking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.'}, {'id': 'OG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.'}], 'classes': [{'title': 'ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.43', 'groupId': 'OG001'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'Evaluated using a 10-point Numeric Pain Rating Scale, where 1 is equivalent to no pain and 10 is equivalent to the worst possible pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT includes all randomized subjects. PP excludes subjects that did not receive the randomized method and/or achieve a procedure success. Number analyzed in each population refers to the subjects with data collected for the specific outcome measure.'}, {'type': 'SECONDARY', 'title': 'Provider Confidence With the Identified Insertion Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.'}, {'id': 'OG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.'}], 'classes': [{'title': 'ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'Evaluated using a 1-5 point Numeric Rating Scale where 1 is equivalent to not at all confident and 5 equivalent to completely confident.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT includes all randomized subjects. PP excludes subjects that did not receive the randomized method and/or achieve a procedure success. Number analyzed in each population refers to the subjects with data collected for the specific outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Localization Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.'}, {'id': 'OG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.'}], 'classes': [{'categories': [{'measurements': [{'value': '197.3', 'spread': '247.03', 'groupId': 'OG000'}, {'value': '170.3', 'spread': '300.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'Time from first touch of draped patient to identification of an insertion site; for VerTouch, this is the time from VerTouch device placement to movement of the applicator to the identified insertion site.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP excludes subjects that did not receive the randomized method and/or achieve a procedure success.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Insertion Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.'}, {'id': 'OG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.'}], 'classes': [{'categories': [{'measurements': [{'value': '303.5', 'spread': '600.79', 'groupId': 'OG000'}, {'value': '301.8', 'spread': '390.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'Time from retrieval of marker or local-anesthetic assembly until no further needle advancements are made.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP excludes subjects that did not receive the randomized method and/or achieve a procedure success.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.'}, {'id': 'OG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.3', 'spread': '16.43', 'groupId': 'OG000'}, {'value': '20.5', 'spread': '28.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of procedure, 1 per subject', 'description': "From positioning of the patient to removal of the drape from the subject's back.", 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP excludes subjects that did not receive the randomized method and/or achieve a procedure success.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Bone Contacts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.'}, {'id': 'OG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '6.04', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '4.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'Number of times the needle contacts bone, counted until confirmation of spinal canal access can be assessed.', 'unitOfMeasure': 'contacts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP excludes subjects that did not receive the randomized method and/or achieve a procedure success.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Unintended Dural Puncture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.'}, {'id': 'OG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'A case that results in puncture of the dura when it is not intended (i.e., in an epidural procedure).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with data for the safety endpoint.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Paresthesia During Needle Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.'}, {'id': 'OG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'A case in which paresthesia is experienced during needle insertion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with data for the safety endpoint.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Traumatic Tap', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.'}, {'id': 'OG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'A case that results in visible blood aspiration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with data for the safety endpoint.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Referral to Radiology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.'}, {'id': 'OG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'A case in which the provider cannot perform the procedure at the bedside and refers the subject to radiology for the procedure to be completed under fluoroscopic guidance.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with data for the safety endpoint.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Conversion From Spinal to Epidural', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.'}, {'id': 'OG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'A case that the provider opts to complete using epidural anesthesia instead of spinal anesthesia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with data for the safety endpoint.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Post-dural Puncture Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.'}, {'id': 'OG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Follow up, 3±2 days after procedure, 1 per subject', 'description': 'A case that results in the patient experiencing one or more headache of any level of severity after the procedure and/or at follow-up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with data for the safety endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.'}, {'id': 'FG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'Received Randomized Location Method', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'Achieved Procedure Success', 'comment': 'Procedure success was defined as confirmation of entry into the spinal canal using standard methods (e.g. return of cerebrospinal fluid from the needle).', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Device not available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Trained provider not available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'After enrollment, subjects meeting eligibility criteria were randomized; the rest were considered screen failures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.\n\nTactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.'}, {'id': 'BG001', 'title': 'Group 2: Control (Palpation)', 'description': 'Palpation used to identify and mark an insertion site.\n\nControl (palpation): Control, palpation used to identify and mark an insertion site.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43.8', 'spread': '17.67', 'groupId': 'BG000'}, {'value': '40.5', 'spread': '18.47', 'groupId': 'BG001'}, {'value': '42.0', 'spread': '18.07', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '41.4', 'spread': '15.55', 'groupId': 'BG000'}, {'value': '39.3', 'spread': '17.78', 'groupId': 'BG001'}, {'value': '40.1', 'spread': '16.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.'}, {'title': 'Age, Customized', 'classes': [{'title': 'ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Adolescent (<22)', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Young Adult (22-40)', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Middle-aged Adult (41-65)', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Older Adult (>65)', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Adolescent (<22)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Young Adult (22-40)', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Middle-aged Adult (41-65)', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Older Adult (>65)', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.'}, {'title': 'Height', 'classes': [{'title': 'ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '165.7', 'spread': '9.53', 'groupId': 'BG000'}, {'value': '165.3', 'spread': '10.36', 'groupId': 'BG001'}, {'value': '165.5', 'spread': '9.93', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '163.5', 'spread': '8.74', 'groupId': 'BG000'}, {'value': '164.8', 'spread': '10.45', 'groupId': 'BG001'}, {'value': '164.3', 'spread': '9.79', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.'}, {'title': 'Weight', 'classes': [{'title': 'ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '81.6', 'spread': '19.40', 'groupId': 'BG000'}, {'value': '80.6', 'spread': '17.71', 'groupId': 'BG001'}, {'value': '81.0', 'spread': '18.42', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '77.6', 'spread': '18.44', 'groupId': 'BG000'}, {'value': '79.9', 'spread': '17.86', 'groupId': 'BG001'}, {'value': '79.0', 'spread': '17.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.'}, {'title': 'BMI', 'classes': [{'title': 'ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29.6', 'spread': '5.94', 'groupId': 'BG000'}, {'value': '29.4', 'spread': '6.56', 'groupId': 'BG001'}, {'value': '29.5', 'spread': '6.24', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29.0', 'spread': '6.10', 'groupId': 'BG000'}, {'value': '29.5', 'spread': '6.37', 'groupId': 'BG001'}, {'value': '29.3', 'spread': '6.37', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'BMI was calculated from subject height and weight, with units of kg/m\\^2.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.'}, {'title': 'BMI, categorical', 'classes': [{'title': 'ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Underweight (<18.5)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Normal (18.5-24.9)', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Overweight (25-29.9)', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Class 1 Obesity (30-34.9)', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Class 2-3 Obesity (≥35)', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Underweight (<18.5)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Normal (18.5-24.9)', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Overweight (25-29.9)', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Class 1 Obesity (30-34.9)', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Class 2-3 Obesity (≥35)', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.'}], 'populationDescription': 'This population includes all randomized subjects and is referred to as the Intent-to-Treat (ITT) population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-25', 'size': 2484566, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-06T15:35', 'hasProtocol': True}, {'date': '2020-12-22', 'size': 1238695, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-06T15:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'An open-label, parallel, randomized study design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'dispFirstSubmitDate': '2022-11-22', 'completionDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-07', 'studyFirstSubmitDate': '2021-03-10', 'resultsFirstSubmitDate': '2024-01-02', 'studyFirstSubmitQcDate': '2021-03-10', 'dispFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-04', 'studyFirstPostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Localization Time', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'Time from first touch of draped patient to identification of an insertion site; for VerTouch, this is the time from VerTouch device placement to movement of the applicator to the identified insertion site.'}, {'measure': 'Insertion Time', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'Time from retrieval of marker or local-anesthetic assembly until no further needle advancements are made.'}, {'measure': 'Total Procedure Time', 'timeFrame': 'End of procedure, 1 per subject', 'description': "From positioning of the patient to removal of the drape from the subject's back."}, {'measure': 'Bone Contacts', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'Number of times the needle contacts bone, counted until confirmation of spinal canal access can be assessed.'}, {'measure': 'Incidence of Unintended Dural Puncture', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'A case that results in puncture of the dura when it is not intended (i.e., in an epidural procedure).'}, {'measure': 'Incidence of Paresthesia During Needle Insertion', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'A case in which paresthesia is experienced during needle insertion.'}, {'measure': 'Incidence of Traumatic Tap', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'A case that results in visible blood aspiration.'}, {'measure': 'Incidence of Referral to Radiology', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'A case in which the provider cannot perform the procedure at the bedside and refers the subject to radiology for the procedure to be completed under fluoroscopic guidance.'}, {'measure': 'Incidence of Conversion From Spinal to Epidural', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'A case that the provider opts to complete using epidural anesthesia instead of spinal anesthesia.'}, {'measure': 'Incidence of Post-dural Puncture Headache', 'timeFrame': 'Follow up, 3±2 days after procedure, 1 per subject', 'description': 'A case that results in the patient experiencing one or more headache of any level of severity after the procedure and/or at follow-up.'}], 'primaryOutcomes': [{'measure': 'Number of Insertion Attempts', 'timeFrame': 'End of procedure, 1 per participant', 'description': 'Any forward movement of the needle following puncture of the skin, counted until confirmation of spinal canal access can be assessed.'}], 'secondaryOutcomes': [{'measure': 'Incidence of First-insertion Success', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'A case that does not require any reinsertions, but can include any number of redirections.'}, {'measure': 'Number of Redirections', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'Any forward movement of the needle in a new direction not preceded by withdrawal from the skin, counted until confirmation of spinal canal access can be assessed.'}, {'measure': 'Number of Passes', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'Any forward movement of the needle, calculated as the sum of insertions and redirections.'}, {'measure': 'Incidence of First-pass Success', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'A case that does not require reinsertions or redirections.'}, {'measure': 'Subject Discomfort During Landmarking', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'Evaluated using a 10-point Numeric Pain Rating Scale, where 1 is equivalent to no pain and 10 is equivalent to the worst possible pain.'}, {'measure': 'Provider Confidence With the Identified Insertion Site', 'timeFrame': 'End of procedure, 1 per subject', 'description': 'Evaluated using a 1-5 point Numeric Rating Scale where 1 is equivalent to not at all confident and 5 equivalent to completely confident.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Diagnostic spinal puncture', 'Therapeutic spinal puncture', 'Lumbar puncture', 'Epidural', 'Neuraxial anesthesia', 'Blood patch', 'ESI'], 'conditions': ['Central Nervous System Infections', 'Pseudotumor Cerebri', 'Neurological Disorder', 'Cancer', 'Obstetric Procedure Pain', 'Orthopedic Procedure Pain', 'Post-Dural Puncture Headache']}, 'descriptionModule': {'briefSummary': 'This study will compare the VerTouch device to the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures.', 'detailedDescription': "Neuraxial procedures, in which a needle is inserted into the spinal canal through a gap in the vertebrae, are performed at a rate of nearly 13 million per year in the US, across a myriad of diagnostic and therapeutic clinical scenarios.\n\nThe standard of care involves manual palpation of the patient's back to detect the spinous processes (SPs) and estimate the location of the interspinous needle insertion site. While providers are trained to perform these procedures with meticulous precision and attention to detail, this technique remains highly inaccurate, often requiring multiple insertion attempts to properly place the needle. These attempts lead to patient pain and complications, such as traumatic taps and post-dural puncture (PDPH) headaches; unpredictable procedure times; and poor facility throughput.\n\nThe VerTouch device uses tactile imaging to offer a non-invasive, untethered, non radiation-producing solution for visualizing spinal anatomy in order to identify an ideal location for needle placement in a neuraxial procedure. The device can be used to mark the identified site with a surgical marker, or to begin placement of a needle or introducer at that site.\n\nStudy participants will be recruited in two parallel cohorts: the control (palpation) group or the tactile imaging (VerTouch) group, further stratified by procedure setting, including emergency medicine, neurology, and anesthesiology. Once an insertion site is marked with a marker or shallow placement of a needle or introducer, the procedure will continue in the usual manner for subjects in both groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and females aged 18 years and above, inclusive\n2. Subjects scheduled for one of the following procedures:\n\n * Diagnostic LP (collection of CSF and/or measurement of ICP to diagnose hemorrhaging or neurological infections)\n * Therapeutic LP (intrathecal injection of therapeutic agents; drainage of CSF to treat pseudotumor cerebri)\n * Planned orthopedic or obstetric procedure, such as labor/induction, cesarean section, hysterectomy, or total hip/knee replacement, with neuraxial anesthesia (injection of anesthetic into spinal and/or epidural space to reduce pain during procedure)\n * Epidural blood patch (use of autologous blood to close holes in the dura mater and relieve PDPH)\n3. Subjects having a BMI ≤42kg/m2\n\nExclusion Criteria:\n\n1. Patient does not provide informed consent\n2. Skin or soft tissue infection near the puncture site\n3. Allergy to local anesthetic\n4. Uncorrected coagulopathy\n5. Acute spinal cord trauma\n6. History of lumbar spinal surgery\n7. Prior known failed neuraxial anesthesia\n8. Diagnosed scoliosis, thoracic kyphosis, lumbar lordosis, scleroderma, or ankylosing spondylitis, or lumbar spinal stenosis\n9. Incarcerated subjects'}, 'identificationModule': {'nctId': 'NCT04796935', 'briefTitle': 'A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control', 'organization': {'class': 'INDUSTRY', 'fullName': 'IntuiTap Medical, Inc'}, 'officialTitle': 'An Open-Label, Parallel, Randomized Study to Evaluate the Performance of Needle Placements for Diagnostic and Therapeutic Neuraxial Procedures, Using a Handheld Tactile Imaging-based Method Versus Palpation', 'orgStudyIdInfo': {'id': 'INT-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group 1: Tactile Imaging (VerTouch)', 'description': 'VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.', 'interventionNames': ['Device: Tactile Imaging (VerTouch)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: Control (palpation)', 'description': 'Palpation used to identify and mark an insertion site.', 'interventionNames': ['Other: Control (palpation)']}], 'interventions': [{'name': 'Tactile Imaging (VerTouch)', 'type': 'DEVICE', 'description': 'VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.', 'armGroupLabels': ['Experimental Group 1: Tactile Imaging (VerTouch)']}, {'name': 'Control (palpation)', 'type': 'OTHER', 'description': 'Control, palpation used to identify and mark an insertion site.', 'armGroupLabels': ['Group 2: Control (palpation)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IntuiTap Medical, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ICON plc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}