Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-02-20 @ 1:44 PM
Study NCT ID:
NCT05329493
Status:
COMPLETED
Last Update Posted:
2025-02-13
First Post:
2022-03-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Novel Cooling Device for Pain Management During Fingerstick Blood Draw
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dmanstein@mgh.harvard.edu', 'phone': '617-726-4893', 'title': 'Dr. Dieter Manstein', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '31 days', 'description': 'Minimal-risk study with healthy participants. Evaluations were ongoing throughout the study to detect adverse events and changes in existing medical conditions.', 'eventGroups': [{'id': 'EG000', 'title': 'Cooling Digit Device Application', 'description': 'The cooling finger device will be applied to all study participants on their hand (fifth or third finger). The hand picked will be randomized and opposite to that of the control hand. Subjects will serve as their own control.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'All study participants will have their fifth or third finger pricked. Subjects will serve as their own control.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Wong-Baker FACES Pain Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'units': 'fingers', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cooling Digit Device Application', 'description': 'The cooling finger device will be applied to all study participants on their hand (fifth or third finger). The hand picked will be randomized and opposite to that of the control hand. Subjects will serve as their own control.'}, {'id': 'OG001', 'title': 'Control', 'description': 'All study participants will have their fifth or third finger pricked. Subjects will serve as their own control.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 1', 'description': 'This scale will be used to record subject pain from the overall pain from the procedure for the treatment and control finger. There are 6 faces ranging from 0 no hurt to 10 hurts the worst.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'fingers', 'denomUnitsSelected': 'fingers'}, {'type': 'SECONDARY', 'title': 'Blood Absorption Via Whatman 903 Filter Paper (Surface Area)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'units': 'fingers', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cooling Digit Device Application', 'description': 'The cooling finger device will be applied to all study participants on their hand (fifth or third finger). The hand picked will be randomized and opposite to that of the control hand. Subjects will serve as their own control.'}, {'id': 'OG001', 'title': 'Control', 'description': 'All study participants will have their fifth or third finger pricked. Subjects will serve as their own control.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'After the finger has been pricked, the finger will subsequently be held over a single-use Whatman 903 filter paper. Approximately every ten seconds after the prick, the filter paper will be gently applied to the blood drop to absorb the blood. This will be repeated on new locations of the filter paper until blood flow stops. At least one Whatman 903 filter paper will be used per finger prick. The Whatman 903 filter paper will be imaged.', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'fingers', 'denomUnitsSelected': 'fingers'}, {'type': 'SECONDARY', 'title': 'Blood Absorption Via Whatman 903 Filter Paper (Drops of Blood)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'units': 'fingers', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cooling Digit Device Application', 'description': 'The cooling finger device will be applied to all study participants on their hand (fifth or third finger). The hand picked will be randomized and opposite to that of the control hand. Subjects will serve as their own control.'}, {'id': 'OG001', 'title': 'Control', 'description': 'All study participants will have their fifth or third finger pricked. Subjects will serve as their own control.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '8.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'After the finger has been pricked, the finger will subsequently be held over a single-use Whatman 903 filter paper. Approximately every ten seconds after the prick, the filter paper will be gently applied to the blood drop to absorb the blood. This will be repeated on new locations of the filter paper until blood flow stops. At least one Whatman 903 filter paper will be used per finger prick. The Whatman 903 filter paper will be imaged.', 'unitOfMeasure': 'number of drops', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'fingers', 'denomUnitsSelected': 'fingers'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cooling Digit Device Application', 'description': 'The cooling finger device will be applied to all study participants on their hand (fifth or third finger). The hand picked will be randomized and opposite to that of the control hand. Subjects will serve as their own control.'}, {'id': 'FG001', 'title': 'Control', 'description': 'All study participants will have their fifth or third finger pricked. Subjects will serve as their own control.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '6'}, {'groupId': 'FG001', 'numUnits': '6', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '6'}, {'groupId': 'FG001', 'numUnits': '6', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'fingers'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cooling Digit Device Application', 'description': "Device: Cooling digit device. The cooling finger device will be applied in the subjects on their right hand. Subjects will serve as their own control.\n\nCooling digit device application: Cooling digit device will be applied on subject's right hand ( fifth finger)."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-10', 'size': 537946, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-04T13:17', 'hasProtocol': True}, {'date': '2023-05-12', 'size': 233541, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-12-04T15:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2022-03-29', 'resultsFirstSubmitDate': '2024-12-18', 'studyFirstSubmitQcDate': '2022-04-07', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-12', 'studyFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wong-Baker FACES Pain Rating Scale', 'timeFrame': 'day 1', 'description': 'This scale will be used to record subject pain from the overall pain from the procedure for the treatment and control finger. There are 6 faces ranging from 0 no hurt to 10 hurts the worst.'}], 'secondaryOutcomes': [{'measure': 'Blood Absorption Via Whatman 903 Filter Paper (Surface Area)', 'timeFrame': 'Day 1', 'description': 'After the finger has been pricked, the finger will subsequently be held over a single-use Whatman 903 filter paper. Approximately every ten seconds after the prick, the filter paper will be gently applied to the blood drop to absorb the blood. This will be repeated on new locations of the filter paper until blood flow stops. At least one Whatman 903 filter paper will be used per finger prick. The Whatman 903 filter paper will be imaged.'}, {'measure': 'Blood Absorption Via Whatman 903 Filter Paper (Drops of Blood)', 'timeFrame': 'Day 1', 'description': 'After the finger has been pricked, the finger will subsequently be held over a single-use Whatman 903 filter paper. Approximately every ten seconds after the prick, the filter paper will be gently applied to the blood drop to absorb the blood. This will be repeated on new locations of the filter paper until blood flow stops. At least one Whatman 903 filter paper will be used per finger prick. The Whatman 903 filter paper will be imaged.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Blood Draw', 'Fingerstick Blood Draw'], 'conditions': ['Blood']}, 'referencesModule': {'references': [{'pmid': '33009571', 'type': 'BACKGROUND', 'citation': 'Jankowski CA, Casapao AM, Siller S, Isache C, Cani KV, Claudio AM, Brown M, Milstid B, Feldhammer M. Preanalytical Challenges During Capillary Fingerstick Sampling Preclude Its Widespread Use in Adult Hospitalized Patients. Am J Clin Pathol. 2021 Feb 11;155(3):412-417. doi: 10.1093/ajcp/aqaa138.'}, {'pmid': '29705575', 'type': 'BACKGROUND', 'citation': 'Kertes DA, Kamin HS, Liu J, Bhatt SS, Kelly M. Putting a finger on the problem: Finger stick blood draw and immunization at the well-child exam elicit a cortisol response to stress among one-year-old children. Psychoneuroendocrinology. 2018 Jul;93:103-106. doi: 10.1016/j.psyneuen.2018.04.021. Epub 2018 Apr 22.'}, {'pmid': '29162770', 'type': 'BACKGROUND', 'citation': 'Iwasawa H, Nishimura T, Nemoto S, Aikawa N, Watanabe K. Correlation of the Blood Test Results Obtained between Assays Using Microliter-scale Fingertip Blood Samples Collected with a Novel Blood Collection Device and Conventional Venous Blood Assays: a Secondary Publication in English. Keio J Med. 2018 Jun 25;67(2):26-34. doi: 10.2302/kjm.2017-0009-OA. Epub 2017 Nov 21.'}, {'pmid': '24800498', 'type': 'BACKGROUND', 'citation': 'Sugimoto S, Tateishi A, Osawa S. [Development of the fingertip blood dilution method for blood cell counting]. Rinsho Byori. 2014 Mar;62(3):235-40. Japanese.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigators seek to evaluate a novel tissue-cooling device for pain management during needle sticks and /or blood draw on the fingertips.', 'detailedDescription': "Patient compliance with laboratory testing is one of the most underrecognized challenges in developing a treatment plan for acute and chronically ill patients. The ability to offer alternatives to standard venipuncture blood draws would greatly increase a laboratory's ability to provide testing to patients and health care providers.The fingerstick blood draw has been used as an alternative.\n\nAiming a less painful, potentially easier alternative we devised a novel that can be applied distally on the digit prior to the blood collection procedure and may provide analgesia through a liquid coolant that is run through tubes in the device to safely cool tissue to achieve numbing. We hypothesize that this device will safely and effectively reduce the pain associated with the fingertip pricks and increase the amount of capillary blood collected.\n\nMultiple punctures with a large lancet were a frequent cause of discomfort among patients.With this new device the discomfort will be reduced by its application followed by the numbness of the finger.\n\nThe investigators plan to have 12 patients to complete the study. Subjects must be equal to greater than 18 years old and younger than 60 years older and may be any gender or Fitzpatrick skin type."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent to participate in the study.\n\n * Male or Female subjects, ≥ 18 and ≤ 60 years of age at the time of enrollment.\n * All Fitzpatrick Skin Types are eligible\n * General good health confirmed by medical history and skin examination of the area to be treated\n * Subjects fifth finger is 17-23mm in diameter at the distal phalanges.\n\nExclusion Criteria:\n\n* • Subject has had a surgical procedure(s) in the intended area of treatment in the last 6 months.\n\n * Sensitivity to the cold or history of cold-induced diseases including Raynaud's disease and cryoglobulinemia\n * Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.\n * Suffering from significant skin conditions in treatment areas or inflammatory skin condition, including but not limited to open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Principal Investigator's discretion) or during the treatment course.\n * History of keloid scarring, abnormal wound healing and /or prone to bruising.\n * History of epidermal or dermal disorders (Particularly if involving collagen or micro vascularity) including collagen vascular disease or vasculitis disorders\n * Subject is unable or unwilling to comply with the study requirements.\n * Subject is currently enrolled or has been enrolled within the prior 3 months in a clinical study of any other unapproved investigational drug or device.\n * Any other condition that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject."}, 'identificationModule': {'nctId': 'NCT05329493', 'briefTitle': 'A Novel Cooling Device for Pain Management During Fingerstick Blood Draw', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'A Novel Cooling Device for Pain Management During Fingerstick Blood Draw', 'orgStudyIdInfo': {'id': '2022P000271'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cooling digit device application', 'description': 'Device: Cooling digit device. The cooling finger device will be applied in the subjects on their right hand. Subjects will serve as their own control.', 'interventionNames': ['Device: Cooling digit device application']}], 'interventions': [{'name': 'Cooling digit device application', 'type': 'DEVICE', 'otherNames': ['cooling finger device'], 'description': "Cooling digit device will be applied on subject's right hand ( fifth finger).", 'armGroupLabels': ['Cooling digit device application']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'MGH Clinical Unit for Research Trials & Outcomes in Skin', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Dieter Manstein, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data (IPD) available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dieter Manstein, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}