Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-02 @ 10:19 AM
Study NCT ID:
NCT04972357
Status:
COMPLETED
Last Update Posted:
2021-07-22
First Post:
2021-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bariatric Procedures and Changes Gastric Passage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-12', 'studyFirstSubmitDate': '2021-07-12', 'studyFirstSubmitQcDate': '2021-07-12', 'lastUpdatePostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric emptying rate', 'timeFrame': 'cross-sectional study. Measured once over a period of 45-60 minutes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Emptying', 'Roux-en-Y Gastric Bypass', 'Bariatric Surgery']}, 'descriptionModule': {'briefSummary': 'Gastric emptying measured with scintigraphy in patients after standard Roux-en-Y Gastric Bypass (S-RYGB), Banded-RYGB (B-RYGB) or Extended pouch-RYGB (E-RYGB).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients who inderwent S-RYGB, B-RYGB or E-RYGB as a primary bariatric surgery.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nFemale patients who underwent S-RYGB, B-RYGB or E-RYGB as a primary bariatric surgery.\n\nExclusion Criteria:\n\n(1) had a disease known to affect appetite, gastric emptying or gastrointestinal motility (e.g., diabetes mellitus or hyper-/hypothyroidism); (2) were unable to stop medications that affect gastric emptying and/or motility three days prior to measurements (e.g., anti-cholinergic drugs, prokinetics, theophylline, calcium blocking agents, opioids); (3) started menopause; (4) were pregnant or lactating; (5) had a drug or alcohol addiction; (6) were unable to stop smoking for 24 hours.'}, 'identificationModule': {'nctId': 'NCT04972357', 'acronym': 'BIP', 'briefTitle': 'Bariatric Procedures and Changes Gastric Passage', 'organization': {'class': 'OTHER', 'fullName': 'Rijnstate Hospital'}, 'officialTitle': 'Bariatric Procedures and Changes in Gut Hormone and Gastric Passage', 'orgStudyIdInfo': {'id': '2018-1172'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard RYGB'}, {'label': 'Banded RYGB'}, {'label': 'Extended pouch RYGB'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Rijnstate Hospital', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}