Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-02-21 @ 10:11 AM
Study NCT ID:
NCT03554902
Status:
RECRUITING
Last Update Posted:
2025-05-01
First Post:
2018-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Gastric Tubulization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2018-05-16', 'studyFirstSubmitQcDate': '2018-06-12', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in weight loss', 'timeFrame': '7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure', 'description': 'Change in weight loss measured in kilograms.'}, {'measure': 'Change in excess weight loss', 'timeFrame': '7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure', 'description': 'Change in excess weight loss measured in percentage. Excess weight loss = (weight loss at time point / weight loss goal to reach a body mass index of 25 kg/m²) x 100'}, {'measure': 'Change in body mass index variation', 'timeFrame': '7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure', 'description': 'Change in body mass index variation measured in kg/m².'}], 'secondaryOutcomes': [{'measure': 'Number of patients with procedure-related adverse event', 'timeFrame': '7 days, 1 - 3 - 6 - 9 and 12 months after procedure', 'description': 'Number of patients with procedure-related adverse event within 12 months after procedure.'}, {'measure': 'Comorbidities improvement', 'timeFrame': '7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure', 'description': 'Improvement of sleep apnea, arterial hypertension, diabetes, reflux, osteoarticular disorders compared with preoperative data.'}, {'measure': 'Quality of life improvement', 'timeFrame': '3 - 12 - 18 and 24 months after procedure', 'description': 'Improvement of quality of life assessed by Moorehead-Ardelt Quality of Life questionnaire II. Score range from -3.0 to 3.0.\n\n* Score from -3.0 to -2.1: very poor quality of life\n* Score from -2.0 to -1.1: poor quality of life\n* Score from -1.0 to 1.0: fair quality of life\n* Score from 1.1 to 2.0: good quality of life\n* Score from 2.1 to 3.0: very good quality of life.'}, {'measure': 'Gastro-intestinal quality of life improvement', 'timeFrame': '3 - 12 - 18 and 24 months after procedure', 'description': 'Improvement of quality of life assessed by the Gastro-Intestinal Quality of Life Index questionnaire. A global score \\> 125 is considered as normal.'}, {'measure': 'Modification in the feeling of satiety', 'timeFrame': '1 - 3 - 6 - 12 - 18 and 24 months after procedure', 'description': 'Satiety assessed by Three Factors Eating Questionnaire - R18. Three dimensions are assessed. The higher the score is, the more important the dimension is.\n\n* Restrained eating: score from 6 to 24\n* Uncontrolled eating: score from 9 to 36\n* Emotional eating: score from 3 to 12.'}, {'measure': 'Upper GI tract radiologic evaluation', 'timeFrame': '1 day, 6 - 12 and 24 months after procedure', 'description': 'Upper GI control series.'}, {'measure': 'Upper GI tract endoscopic evaluation', 'timeFrame': '6 - 12 and 24 months after procedure', 'description': 'Upper GI control gastroscopy.'}, {'measure': 'Procedure duration', 'timeFrame': 'At time of procedure', 'description': 'Time required to perform the endoscopic gastric tubulization.'}, {'measure': 'Number of stitches in place', 'timeFrame': 'At time of procedure', 'description': 'Number of stitches put in place during the endoscopic gastric tubulization.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endoscopic gastric tubulization', 'Weight loss', 'Quality of life'], 'conditions': ['Morbid Obesity']}, 'referencesModule': {'references': [{'pmid': '25380508', 'type': 'BACKGROUND', 'citation': 'Lopez-Nava G, Galvao MP, da Bautista-Castano I, Jimenez A, De Grado T, Fernandez-Corbelle JP. Endoscopic sleeve gastroplasty for the treatment of obesity. Endoscopy. 2015 May;47(5):449-52. doi: 10.1055/s-0034-1390766. Epub 2014 Nov 7.'}, {'pmid': '26003549', 'type': 'BACKGROUND', 'citation': 'Lopez-Nava G, Galvao MP, Bautista-Castano I, Jimenez-Banos A, Fernandez-Corbelle JP. Endoscopic Sleeve Gastroplasty: How I Do It? Obes Surg. 2015 Aug;25(8):1534-8. doi: 10.1007/s11695-015-1714-7.'}, {'pmid': '26878054', 'type': 'BACKGROUND', 'citation': 'Lopez-Nava G, Galvao M, Bautista-Castano I, Fernandez-Corbelle JP, Trell M. Endoscopic sleeve gastroplasty with 1-year follow-up: factors predictive of success. Endosc Int Open. 2016 Feb;4(2):E222-7. doi: 10.1055/s-0041-110771. Epub 2016 Jan 15.'}, {'pmid': '25380510', 'type': 'BACKGROUND', 'citation': 'Sharaiha RZ, Kedia P, Kumta N, DeFilippis EM, Gaidhane M, Shukla A, Aronne LJ, Kahaleh M. Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population. Endoscopy. 2015 Feb;47(2):164-6. doi: 10.1055/s-0034-1390773. Epub 2014 Nov 7.'}, {'pmid': '23711556', 'type': 'BACKGROUND', 'citation': 'Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013 Sep;78(3):530-5. doi: 10.1016/j.gie.2013.04.197. Epub 2013 May 24.'}]}, 'descriptionModule': {'briefSummary': 'Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). It is standard practice since October 2016.\n\nThe objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. These data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.', 'detailedDescription': 'Gastric restriction is one of the fundamental principles of gastric bypass and gastric banding. Despite its advantages (long term weight loss, comorbidities related to obesity improvement…), bariatric surgery is risky. In fact, complications putting the patient into a life-threatening condition can occur. Endoscopic approaches are similar to current surgical methods but less invasive, safer and allow ambulatory care.\n\nNowadays, practitioners have the possibility to reduce stomach size by merging tissues through an endoscopic endoluminal suture approach without any incision. This leads to similar results (gastric restriction, weight loss, quality of life and comorbidities improvement) compared with standard surgical procedure while reducing the risk of complications.\n\nOne of the major benefit of this technique is its reversibility. A new surgical or endoscopic procedure is possible at a later stage.\n\nEndoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). It is standard practice since October 2016.\n\nThe objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. These data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 18 years old requiring a treatment for morbid obesity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for an endoscopic gastric tubulization in the Nouvel Hôpital Civil, Strasbourg, France'}, 'identificationModule': {'nctId': 'NCT03554902', 'acronym': 'Endosleeve', 'briefTitle': 'Endoscopic Gastric Tubulization', 'organization': {'class': 'OTHER', 'fullName': 'IHU Strasbourg'}, 'officialTitle': 'Endoscopic Gastric Tubulization', 'orgStudyIdInfo': {'id': '16-001-OBS (CPP)'}, 'secondaryIdInfos': [{'id': '2017-A03599-44', 'type': 'OTHER', 'domain': 'ANSM France'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endoscopic gastric tubulization', 'description': 'Endoscopic gastric tubulization is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA).', 'interventionNames': ['Procedure: Endoscopic gastric tubulization']}], 'interventions': [{'name': 'Endoscopic gastric tubulization', 'type': 'PROCEDURE', 'description': 'Endoscopic gastric tubulization is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA).', 'armGroupLabels': ['Endoscopic gastric tubulization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Silvana Perretta, MD, PhD', 'role': 'CONTACT', 'email': 'silvana.perretta@ircad.fr', 'phone': '+ 33 3 69 55 05 31'}, {'name': 'Michel Vix, MD', 'role': 'CONTACT', 'email': 'michel.vix@chru-strasbourg.fr', 'phone': '+33 3 69 55 13 09'}, {'name': 'Silvana Perretta, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michel Vix, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': "Antonio D'Urso, MD", 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Silvana Perretta, MD, PhD', 'role': 'CONTACT', 'email': 'silvana.perretta@ircad.fr', 'phone': '+ 33 3 69 55 05 31'}, {'name': 'Michel Vix, MD', 'role': 'CONTACT', 'email': 'michel.vix@chru-strasbourg.fr', 'phone': '+ 33 3 69 55 13 03'}], 'overallOfficials': [{'name': 'Silvana Perretta, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg'}, {'name': 'Michel Vix, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IHU Strasbourg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}