Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2016-10-31
2020-05-31
Brief Summary
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The primary objective of this study is to assess weight loss after endoscopic sleeve gastroplasty in patients with morbid obesity.
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Detailed Description
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The primary objective of this study is to assess weight loss after endoscopic sleeve gastroplasty in patients with morbid obesity according to the technique described in the literature: reduction of the gastric pouch into a sleeve structure by modification of the stomach greater curvature thanks to a plication.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Endoscopic sleeve gastroplasty
Endoscopic sleeve gastroplasty is performed using a CE marked endoscopic suture device (Overstitch, Apollo Endosurgery, Austin, Tx. USA). Continuous stitches are placed to create a sleeve-shaped gastric path of 2 cm diameter to reduce stomach volume from the proximal antrum to the oeso-gastric junction.
Endoscopic sleeve gastroplasty
Endoscopic sleeve gastroplasty is performed using a CE marked endoscopic suture device (Overstitch, Apollo Endosurgery, Austin, Tx. USA). Continuous stitches are placed to create a sleeve-shaped gastric path of 2 cm diameter to reduce stomach volume from the proximal antrum to the oeso-gastric junction.
Interventions
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Endoscopic sleeve gastroplasty
Endoscopic sleeve gastroplasty is performed using a CE marked endoscopic suture device (Overstitch, Apollo Endosurgery, Austin, Tx. USA). Continuous stitches are placed to create a sleeve-shaped gastric path of 2 cm diameter to reduce stomach volume from the proximal antrum to the oeso-gastric junction.
Eligibility Criteria
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Inclusion Criteria
* Patient with morbid obesity for at least 2 years
* Patient who failed medical and diet treatment of obesity
* Patient with no contraindication to anesthesia
* Patient able to understand the study and to provide informed consent.
Exclusion Criteria
* Patient with a history of gastro-intestinal inflammatory disease, stenosis or intestinal adhesions, kidney or liver failure, chronic pancreatic disease
* Patient with a history and/or signs and/or symptoms of gastroduodenal ulcerous disease and/or progressive gastroduodenal ulcerous disease
* Patient with an oesophageal pathology as Zenker's diverticulum, peptic oesophagitis stage 3-4, oesophageal stenosis, Barrett syndrome, oesophageal cancer, dysphagia, achalasia
* Patient with previous bariatric, gastric or oesophageal surgery, intestinal obstruction, portal hypertension, gastro-intestinal tumors, oesophageal or gastric varices, gastroparesis
* Patient with a severe coagulopathy (prothrombin time \> 3 seconds or thrombocytic count \< 50 000/mm3) or treated with heparin, coumadin, warfarin or any other anticoagulants and drugs preventing coagulation or platelet aggregation, except aspirin and nonsteroidal anti-inflammatory drugs
* Pregnancy, breastfeeding or woman without contraception
* Patient with a congestive heart failure, arrhythmia or unstable coronary heart disease
* Patient using or having used diet drugs within the last 30 days or intending to use them during study follow-up
* Patient under drug treatment within the last 3 months known to induce weight gain
* Patient with eating disorders or uncontrolled, poorly controlled or suspected psychiatric disease
* Patient in a poor condition according to investigator
* Patient in exclusion period (determined by a previous study or in progress)
* Patient with significative weight loss between date of enrollment in the study and date of procedure
* Patient with a systemic infection the day of procedure.
18 Years
60 Years
ALL
No
Sponsors
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IHU Strasbourg
OTHER
Responsible Party
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Principal Investigators
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Silvana Perretta, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg
Michel Vix, MD
Role: PRINCIPAL_INVESTIGATOR
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg
Locations
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Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg
Strasbourg, , France
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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16-001-OBS
Identifier Type: -
Identifier Source: org_study_id
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