Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-26 @ 7:18 AM
Study NCT ID:
NCT03088332
Status:
COMPLETED
Last Update Posted:
2022-08-17
First Post:
2017-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy and Results of Endoscopic Gastroplasty Performed Using Overstitch in Patients With Obesity.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-16', 'studyFirstSubmitDate': '2017-03-06', 'studyFirstSubmitQcDate': '2017-03-17', 'lastUpdatePostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': '48 weeks', 'description': 'Weight in Kg and Body Mass Index (BMI) in kilograms by meters squared'}], 'secondaryOutcomes': [{'measure': 'Blood count', 'timeFrame': '48 weeks', 'description': 'Measured in cmm'}, {'measure': 'Hb1AC', 'timeFrame': '48 weeks', 'description': 'Measured in percentage'}, {'measure': 'Cholesterol', 'timeFrame': '48 weeks', 'description': 'Measured in mg/dL'}, {'measure': 'Fasting blood glucose', 'timeFrame': '48 weeks', 'description': 'Measured in mg/dL'}, {'measure': 'Procedural complications', 'timeFrame': 'At the time of procedure and at 6 months and 1 year follow-up period', 'description': 'Complications related to the procedure, either at the time of the procedure (bleeding, perforation and suture rupture) or in the postoperative period, performing an endoscopy at 6 months and 1 year to evaluate the suture line.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'Obesity is a chronic disease that has grown to epidemic characteristics in Brazil and around the world in recent years. Treatment for patients with class III or class II obesity with comorbidities is already well established, with bariatric surgery being the best option. However, there is no consensus as to the best treatment for cases of class I and class II obesity without comorbidities. The objective of this research will be to make a gastric tube similar to that obtained in surgical gastroplication however it will be created using intragastric endoscopic sutures. The procedures will be performed at the Endoscopy Service of the Mario Covas Hospital in São Paulo, SP. Data collection will be performed at the same location.', 'detailedDescription': 'The objective of this research will be to make a gastric tube similar to that obtained in surgical gastroplication however it will be created using intragastric endoscopic sutures. The secondary objective will be to correlate demographic, endoscopic and laboratory data with the results of this procedure.\n\nPatients and Methods: Patients with class I obesity with or without comorbidities and patients with class II obesity without comorbidities, irrespective of gender and ethnic background, from the state of São Paulo and other states of the country will be submitted to vertical endoscopic gastroplasty. The procedures will be performed at the Endoscopy Service of the Mario Covas Hospital in São Paulo, SP. Data collection will be performed at the same location.\n\nInformation will be obtained during the outpatient follow-up at the Hospital Mario Covas including demographic (gender, age), clinical (height, weight, time after procedure, systemic arterial hypertension, diabetes, dyslipidemia, smoking, alcohol consumption) and operative data (complications).\n\nPreparation for the procedure: All the exams will be performed at the Hospital Mario Covas after the patients have fasted for at least 8 hours. The procedure will begin with the patient in left lateral decubitus under general anesthesia performed by an anesthesiologist. Endoscopic sutures will be performed using 2-0 prolene thread until a tubular-shaped stomach is formed similar to a vertical gastrectomy.\n\nRecovery after the procedure: After the procedure and recovery from anesthesia, all patients will be discharged but only together with a companion. All patients will receive guidance and will remain in touch with a physician to report any adverse signs or symptoms.\n\nOutcomes Primary outcome: To confirm the efficacy of endoscopic sutures in the primary treatment of obesity.\n\nSecondary outcome: To evaluate the use of the endoscopic sutures in relation to demographic data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 30 and \\< 36 with or without comorbidities\n* BMI \\> 36 and \\< 40 without comorbidities\n\nExclusion Criteria:\n\n* Prior gastric surgery\n* Use of anticoagulants\n* Psychiatric disorders\n* Severe esophagitis'}, 'identificationModule': {'nctId': 'NCT03088332', 'briefTitle': 'Evaluating the Efficacy and Results of Endoscopic Gastroplasty Performed Using Overstitch in Patients With Obesity.', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Clinic and Hospital'}, 'officialTitle': 'Prospective Multicenter Study to Evaluate the Efficacy and Results of Endoscopic Gastroplasty Performed Using Overstitch in Patients With Class I and II Obesity.', 'orgStudyIdInfo': {'id': '1854540'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endoscopic gastroplasty', 'description': 'Make a gastric tube similar to that obtained in surgical gastroplication however it will be created using intragastric endoscopic sutures.', 'interventionNames': ['Procedure: Endoscopic gastroplasty']}], 'interventions': [{'name': 'Endoscopic gastroplasty', 'type': 'PROCEDURE', 'description': 'Vertical endoscopic gastroplasty', 'armGroupLabels': ['Endoscopic gastroplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09190-615', 'city': 'Santo André', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Mario Covas Hospital', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'city': 'São José do Rio Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Kaiser Day hospital', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}, {'zip': '01409-002', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': '9 de Julho Hospital', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Luiz Guatavo de Quadros, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Clinica and Day Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Clinic and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}