Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT03493620
Status:
COMPLETED
Last Update Posted:
2022-08-17
First Post:
2018-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Results of Endoscopic Gastroplasty Using Overstitch in Patients With Class I and II 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-16', 'studyFirstSubmitDate': '2018-03-14', 'studyFirstSubmitQcDate': '2018-04-03', 'lastUpdatePostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': 'outcome will be evaluated for 2 years', 'description': 'weight in kg'}], 'secondaryOutcomes': [{'measure': 'Weight maintenance', 'timeFrame': '2 years', 'description': 'weight in kg'}, {'measure': 'Surgical related complications', 'timeFrame': '2 years'}, {'measure': 'Comorbidities', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'Obesity is a chronic disease that has grown to epidemic proportions in Brazil and throughout the world in recent years. Bariatric surgery has been the most effective method for the treatment and prophylaxis of complications caused by morbid obesity, thereby increasing the longevity and quality of life of patients. The treatment of patients with Class III obesity or higher or Class II with comorbidities is already well established with bariatric surgery being the best option. However, there is no consensus as to the best treatment in cases of Class I or II obesity without comorbidities. The objective of this research will be to make a gastric tube similar to that obtained by surgical gastroplication but using endoscopic intragastric sutures.', 'detailedDescription': 'The primary objective of this research will be to make a gastric tube similar to that obtained by surgical gastroplication but using endoscopic intragastric sutures. The secondary objective will be to correlate demographic, endoscopic and laboratory data with the outcomes.\n\nThis study will be carried out in two institutions. The Kaiser Clinic and Day Hospital and the Faculty of Medicine of ABC. Sixty patients will be randomly selected for treatment by Endospore Endoscopy (ESG) or as controls (only the endoscopist will know which group each patient belongs to). The draw will take place only after upper endoscopy has been carried out to avoid possible contraindications for the procedure due to injuries. Once the criteria for endoscopic evaluation have been met, randomization will be carried out in loco with the patient still sedated. Gastric Endo Sutures will be performed when the patient is randomized for Group I; Group II will be the control group. All patients will be followed up for two years by a multidisciplinary team (endoscopist, surgeon, nutritionist and psychologist). The data will be obtained during the outpatient follow-up at the Hospital Mario Covas and will include demographic (gender, age), clinical (height, weight, BMI, time after procedure, hypertension, diabetes, dyslipidemia, smoking, alcoholism) and operative data (complications).\n\nPreparation to perform the examination/procedure: All exams will be performed with the patients within eight hours. The procedure will begin with the patient in left lateral decubitus position and under general anesthesia performed by an anesthesiologist. Endoscopic suturing will be performed with 2-0 prolene stitches until a tubular-shaped stomach is formed similar to vertical gastrectomy.\n\nRecovery after the procedure: After this procedure and recovery from the anesthesia, all patients will only be discharged in the company of a companion. All patients will be counseled to enter in touch with the physician to report any signs or symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged over 18 years,\n* BMI \\> 30 and \\< 36 kg/m2, with or without comorbidities,\n* BMI \\> 36 and \\< 40 without comorbidities\n\nExclusion Criteria:\n\n* Previous gastric surgery\n* Taking anticoagulant drugs\n* Psychiatric disorders\n* Severe esophagitis'}, 'identificationModule': {'nctId': 'NCT03493620', 'briefTitle': 'Efficacy and Results of Endoscopic Gastroplasty Using Overstitch in Patients With Class I and II Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Clinic and Hospital'}, 'officialTitle': 'Multicenter Randomized Prospective Study With Sham Group to Evaluate the Efficacy and Results of Endoscopic Gastroplasty Using Overstitch in Patients With Class I and II Obesity', 'orgStudyIdInfo': {'id': 'ApolloSham'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device arm', 'description': 'Gastric endosuturing will be performed until the entire gastric body is sutured in the form of a tube.', 'interventionNames': ['Procedure: Device arm']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham arm', 'description': 'Group II is a control group (only the endoscopist will know which group each patient belongs to)', 'interventionNames': ['Procedure: Sham arm']}], 'interventions': [{'name': 'Device arm', 'type': 'PROCEDURE', 'description': 'Make a gastric tube (endoscopic sleeve gastroplasty) using the Apollo Overstitch suturing device through endoscopy.', 'armGroupLabels': ['Device arm']}, {'name': 'Sham arm', 'type': 'PROCEDURE', 'description': 'Group II will be conducted identically to Group I except for the procedure itself, and only the endoscopist, that is the researcher, will be aware of which group each patient belongs to.', 'armGroupLabels': ['Sham arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santo André', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Faculty of Medicine of ABC', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'city': 'São José do Rio Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Kaiser Clinic and Day Hospital', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}], 'overallOfficials': [{'name': 'Luiz Gustavo de Quadros, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Clinica and Day Hospital'}, {'name': 'Eduardo Grecco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ABC Medical School'}, {'name': 'Manoel Galvao Neto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ABC Medical School'}, {'name': 'Thiago Ferreira de Souza, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ABC Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Clinic and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}