Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-01 @ 1:34 AM
Study NCT ID:
NCT04392635
Status:
COMPLETED
Last Update Posted:
2025-07-01
First Post:
2020-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Device to Assist With Abdominal Access During Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'smeyer27@stanford.edu', 'phone': '650-723-6189', 'title': 'Study Team', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '21 days', 'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care (SOC)', 'description': 'Participants receive SOC including direct (unassisted) entry and/or assisted entry using clamps, if needed, to aid in Veress needle insertion, prior to initiating insufflation.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 14, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TauTona Pneumoperitoneum Assist Device (TPAD)', 'description': 'Participants receive investigational TPAD device during laparoscopic surgery prior to Veress needle entry and removed after insufflation is completed.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 14, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Bruising', 'notes': 'Bruising surrounding the Veress needle insertion site.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Fluid Collection', 'notes': 'Fluid collection in the gallbladder fossa with possible fistulization to the duodenum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Surgeon Satisfaction Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'Participants receive SOC including direct (unassisted) entry and/or assisted entry using clamps, if needed, to aid in Veress needle insertion, prior to initiating insufflation.'}, {'id': 'OG001', 'title': 'TauTona Pneumoperitoneum Assist Device (TPAD)', 'description': 'Participants receive investigational TPAD device during laparoscopic surgery prior to Veress needle entry and removed after insufflation is completed.'}], 'classes': [{'title': 'Obtaining counter traction for the Veress Needle was straightforward', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '4'}]}]}, {'title': 'Advancing the Veress Needle into the peritoneal cavity was straightforward', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '4'}]}]}, {'title': 'The Veress Needle was accurately inserted', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '4'}]}]}, {'title': 'Advancing the Veress Needle into the peritoneal cavity was safe', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '4'}]}]}, {'title': 'Inserting the Veress needle could be done by one physician', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '4'}]}]}, {'title': 'Initiating and completing insufflation was straightforward', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 1 minute on day of surgery', 'description': 'The surgeon completes a LIKERT scale satisfaction survey related to the TPAD to assess its ease of use. Scale range 1-5 (higher scores correspond to higher satisfaction)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the protocol'}, {'type': 'SECONDARY', 'title': 'Time From Incision for Veress Needle Insertion to Start of Insufflation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'Participants receive SOC including direct (unassisted) entry and/or assisted entry using clamps, if needed, to aid in Veress needle insertion, prior to initiating insufflation.'}, {'id': 'OG001', 'title': 'TauTona Pneumoperitoneum Assist Device (TPAD)', 'description': 'Participants receive investigational TPAD device during laparoscopic surgery prior to Veress needle entry and removed after insufflation is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.0', 'groupId': 'OG000', 'lowerLimit': '69.5', 'upperLimit': '121.5'}, {'value': '92.0', 'groupId': 'OG001', 'lowerLimit': '81.5', 'upperLimit': '127.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 2 minutes', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the protocol'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'Participants receive SOC including direct (unassisted) entry and/or assisted entry using clamps, if needed, to aid in Veress needle insertion, prior to initiating insufflation.'}, {'id': 'OG001', 'title': 'TauTona Pneumoperitoneum Assist Device (TPAD)', 'description': 'Participants receive investigational TPAD device during laparoscopic surgery prior to Veress needle entry and removed after insufflation is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Continuous from start of surgery through postoperative day 7', 'description': 'Adverse events related to use of the TPAD device', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care (SOC)', 'description': 'Participants receive SOC including direct (unassisted) entry and/or assisted entry using clamps, if needed, to aid in Veress needle insertion, prior to initiating insufflation.'}, {'id': 'FG001', 'title': 'TauTona Pneumoperitoneum Assist Device (TPAD)', 'description': 'Participants receive investigational TPAD device during laparoscopic surgery prior to Veress needle entry and removed after insufflation is completed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care (SOC)', 'description': 'Participants receive SOC including direct (unassisted) entry and/or assisted entry using clamps, if needed, to aid in Veress needle insertion, prior to initiating insufflation.'}, {'id': 'BG001', 'title': 'TauTona Pneumoperitoneum Assist Device (TPAD)', 'description': 'Participants receive investigational TPAD device during laparoscopic surgery prior to Veress needle entry and removed after insufflation is completed.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-40 years old', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': '41-64 years old', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': '65 and over', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'White; Non-Hispanic/Non- Latino', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Asian; Non-Hispanic/Non- Latino', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'title': '18.5-24.9 kg/m^2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': '25.0-29.9 kg/m^2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': '30.0-34.9 kg/m^2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Skin Striae Severity', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Extremely Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Mild: Few striae, relatively small in size, and may be slightly discolored. Moderate: More numerous striae, slightly wider, and may be a more noticeable color.\n\nSevere: Many striae, wider, and may be a more prominent color (red, purple, or white).\n\nExtremely Severe: Extensive striae covering a large area, wide, and deeply colored (red, purple, or white).', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who completed the protocol'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-16', 'size': 325493, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-04T19:12', 'hasProtocol': True}, {'date': '2024-08-19', 'size': 139263, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-11T16:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2020-05-13', 'resultsFirstSubmitDate': '2025-06-11', 'studyFirstSubmitQcDate': '2020-05-13', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-27', 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgeon Satisfaction Survey', 'timeFrame': 'up to 1 minute on day of surgery', 'description': 'The surgeon completes a LIKERT scale satisfaction survey related to the TPAD to assess its ease of use. Scale range 1-5 (higher scores correspond to higher satisfaction)'}], 'secondaryOutcomes': [{'measure': 'Time From Incision for Veress Needle Insertion to Start of Insufflation', 'timeFrame': 'Up to approximately 2 minutes'}, {'measure': 'Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0', 'timeFrame': 'Continuous from start of surgery through postoperative day 7', 'description': 'Adverse events related to use of the TPAD device'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Laparoscopic Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and ease of use of a TauTona Pneumoperitoneum Assist Device (TPAD) to assist with obtaining peritoneal access with a Veress needle, and for placing a primary trocar, during laparoscopic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>/= 18\n* Scheduled for laparoscopic surgery\n* Able to understand and willing to sign a written informed consent form\n\nExclusion Criteria:\n\n* Age \\< 18\n* Any situation where blind, peri-umbilical passage of a Veress needle is contraindicated.\n* Any situation where patients have suspected or confirmed intra-abdominal adhesions involving the peri-umbilical abdominal wall.\n* Any situation where patients have a suspected or confirmed umbilical hernia or peri-umbilical ventral hernia.\n* Any situation where there is not intact, uncompromised skin of the peri-umbilical region where the device is to be placed.'}, 'identificationModule': {'nctId': 'NCT04392635', 'briefTitle': 'Device to Assist With Abdominal Access During Laparoscopic Surgery', 'nctIdAliases': ['NCT06361849'], 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Pilot Study to Establish Safety and Ease of Use of a TauTona Pneumoperitoneum Assist Device (TPAD) for Laparoscopic Surgery', 'orgStudyIdInfo': {'id': 'IRB-55013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TauTona Pneumoperitoneum Assist Device (TPAD)', 'description': 'Participants will receive investigational TPAD device during laparoscopic surgery. The TPAD was used to aid Veress needle insertion in place of surgical tools such as clamps. The TPAD was applied to the patient prior to Veress needle entry and removed after insufflation was completed.', 'interventionNames': ['Device: TauTona Pneumoperitoneum Assist Device (TPAD)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care (SOC)', 'description': 'Participants will receive SOC included both direct (unassisted) entry and assisted entry using clamps, if needed, to aid in Veress needle insertion. Upon confirmation that the Veress needle was in the correct location (e.g. drop test), insufflation was initiated.', 'interventionNames': ['Procedure: Standard of Care (SOC)']}], 'interventions': [{'name': 'TauTona Pneumoperitoneum Assist Device (TPAD)', 'type': 'DEVICE', 'description': 'The TPAD is an experimental device used to assist with placement of Veress needle during laparoscopic surgery.', 'armGroupLabels': ['TauTona Pneumoperitoneum Assist Device (TPAD)']}, {'name': 'Standard of Care (SOC)', 'type': 'PROCEDURE', 'description': 'Standard of Care was used for Veress needle insertion.', 'armGroupLabels': ['Standard of Care (SOC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'James R Korndorffer Jr, MD MHPE FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'TauTona Group', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}