Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-31 @ 7:32 AM
Study NCT ID:
NCT06407193
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastric Emptying After Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2024-04-25', 'studyFirstSubmitQcDate': '2024-05-06', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric emptying compared between patients with poor and successful weight loss', 'timeFrame': '2-3 years', 'description': 'Gastric emptying (T1/2 \\[min\\] and retention \\[%/min\\])'}, {'measure': 'Gastric emptying compared between measured with MRI and scintigraphy', 'timeFrame': '2-3 years', 'description': 'Gastric emptying (T1/2 \\[min\\] and retention \\[%/min\\])'}], 'secondaryOutcomes': [{'measure': 'Sleeve characteristics compared between patients with successful and unsuccessful (poor) weight loss', 'timeFrame': '2-3 years', 'description': 'Volume (sleeve size \\[mL\\] and gastric acid \\[mL\\])'}, {'measure': 'to assess the association between gastric emptying rate and gastric sleeve characteristics in each group', 'timeFrame': '2-3 years', 'description': 'association between outcome 1, 2 and 3'}, {'measure': 'to compare subjective ratings of gastric fullness and wellbeing between patients with successful and unsuccessful weight loss', 'timeFrame': '2-3 years', 'description': 'questionnaires (VAS-scale, MAIA, HADS, EBBS, Power of food scale, and Food tolerance test)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric emptying', 'Gastric sleeve', 'MRI', 'Scintigraphy'], 'conditions': ['Gastric Emptying', 'Bariatric Surgery']}, 'descriptionModule': {'briefSummary': 'Sleeve gastrectomy (SG) increases gastrointestinal motility, which influences feelings of fullness and satiety. By understanding the differences in gastric emptying (GE) between patients with sufficient weight loss (Total weight loss \\[TWL\\] \\> 35%) and insufficient weight loss (TWL \\< 25%), better insight in the aetiology of weight loss after sleeve gastrectomy may be obtained. GE will be measured with scintigraphy and MRI.', 'detailedDescription': "Sleeve gastrectomy (SG) increases gastrointestinal motility, which influences feelings of fullness and satiety. Patients' weight loss response on SG varies widely and is difficult to predict. By understanding the differences in gastric emptying (GE) between patients with sufficient weight loss (Total weight loss \\[TWL\\] \\> 35%) and insufficient weight loss (TWL \\< 25%), better insight in the aetiology of weight loss after sleeve gastrectomy may be obtained. GE will be measured with scintigraphy and MRI. MRI is a non-invasive imaging method which provides more detailed images of the SG compared to the conventionally used scintigraphy scans."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women after sleeve gastrectomy with either good or poor weight loss', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with either TWL \\< 25% or TWL \\> 35%.\n* Patients who had a follow-up period of 2-3 years after sleeve gastrectomy\n\nExclusion Criteria:\n\n* Maximum BMI \\>50 kg/m2\n* Patients with a disease known to affect appetite, gastric emptying or gastrointestinal motility\n* Patients who are unable to stop medications that affect gastric emptying and/or motility prior to measurements. It is depending on t1/2 for how long they need to stop medication\n* Patients who started menopause\n* Patients with gastrointestinal problems or, gastric or intestinal diseases\n* Patients with a drug or alcohol addiction\n* Patients who are unable to stop smoking for 24h\n* Patients who are pregnant or lactating\n* Patients who have an intolerance or allergy for one of the components of the test product\n* Patients who have a contra-indication to MRI scanning'}, 'identificationModule': {'nctId': 'NCT06407193', 'acronym': 'EMRISS', 'briefTitle': 'Gastric Emptying After Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Rijnstate Hospital'}, 'officialTitle': 'Gastric Emptying Measured With MRI and Scintigraphy in Patients With Successful Versus Unsuccessful Weight Loss After Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': '2020-1690'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Poor weight loss group', 'description': 'Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with TWL \\< 25%', 'interventionNames': ['Other: MRI and scintigraphy']}, {'label': 'Successful weight loss group', 'description': 'Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with TWL \\> 35%', 'interventionNames': ['Other: MRI and scintigraphy']}], 'interventions': [{'name': 'MRI and scintigraphy', 'type': 'OTHER', 'description': 'Gastric emptying measured with MRI and scintigraphy', 'armGroupLabels': ['Poor weight loss group', 'Successful weight loss group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6815AD', 'city': 'Arnhem', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Veerbeek', 'role': 'CONTACT', 'email': 'tveerbeek@rijnstate.nl', 'phone': '+31 880052115'}], 'facility': 'Rijnstate Hospital', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}], 'centralContacts': [{'name': 'Veerbeek', 'role': 'CONTACT', 'email': 'tveerbeek@rijnstate.nl', 'phone': '+31 880052115'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wageningen University and Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}