Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-02-23 @ 4:31 AM
Study NCT ID:
NCT05715892
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-12
First Post:
2023-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examining Patterns in the Involvement of Gastric Bypass Patients in Clinical Studies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-26', 'size': 79337, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-01-27T00:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-09', 'studyFirstSubmitDate': '2023-01-27', 'studyFirstSubmitQcDate': '2023-01-27', 'lastUpdatePostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who decide to participate in a gastric bypass clinical study', 'timeFrame': '3 months'}, {'measure': 'Rate of gastric bypass patients who remain until trial completion', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric bypass', 'weight loss surgery'], 'conditions': ['Gastric Bypass', 'Weight Loss Surgery']}, 'referencesModule': {'references': [{'pmid': '25105982', 'type': 'BACKGROUND', 'citation': 'Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev. 2014 Aug 8;2014(8):CD003641. doi: 10.1002/14651858.CD003641.pub4.'}, {'pmid': '10102217', 'type': 'BACKGROUND', 'citation': 'Fisher BL, Barber AE. Gastric bypass procedures. Eur J Gastroenterol Hepatol. 1999 Feb;11(2):93-7. doi: 10.1097/00042737-199902000-00007.'}, {'pmid': '17938315', 'type': 'BACKGROUND', 'citation': 'Collins BJ, Miyashita T, Schweitzer M, Magnuson T, Harmon JW. Gastric bypass: why Roux-en-Y? A review of experimental data. Arch Surg. 2007 Oct;142(10):1000-3; discussion 1004. doi: 10.1001/archsurg.142.10.1000.'}]}, 'descriptionModule': {'briefSummary': "Clinical trial participation has historically been heavily biased toward specific demographics.\n\nSeveral people will be invited to enroll in this study so that it may collect a variety of data about gastric bypass clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.\n\nThe information collected from this study can be used to improve patient experience and outcomes for future patients and an opportunity to contribute to the advancement of medical knowledge and treatments for gastric bypass."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Gastric bypass patients who are actively considering participating in an observational clinical trial, but have not yet completed enrollment and randomization.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and older\n* Diagnosis of obesity or disorder of metabolism undergoing routine gastric bypass surgical intervention\n* Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n* ECOG score of 4\n* Ineligible for gastric bypass surgery\n* Pregnant women or women actively seeking to become pregnant.'}, 'identificationModule': {'nctId': 'NCT05715892', 'briefTitle': 'Examining Patterns in the Involvement of Gastric Bypass Patients in Clinical Studies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Power Life Sciences Inc.'}, 'officialTitle': 'An Observational Study Investigating The Experiences of Patients In Gastric Bypass Clinical Trials', 'orgStudyIdInfo': {'id': '80772648'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'bask@withpower.com', 'phone': '4159004227'}], 'overallOfficials': [{'name': 'Michael B Gill', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Power Life Sciences Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Power Life Sciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}