Endomina Controlled Study

NCT03255005 | Completed DMC

• 1 other identifier: P2017/401
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 2

Brief Summary

The aim of this trial is to evaluate the efficacy of an endoluminal vertical gastroplasty (EVG) using an endoluminal-suturing device. Safety will also be characterized, in particular by the incidence of all Adverse Device Effects (ADEs). A secondary endpoint is to compare a delayed treatment control group (diet alone; crossover at 6 months) with a treatment group (EVG plus diet). Other secondary endpoints include improvements in other obesity measures.

Conditions

Obesity

Keywords

obesity; endoscopy; endoscopic sleeve gastroplasty

Outcome Measures

Primary Outcomes (2)

• Incidence of all Adverse Device Effects

  Safety will be characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants.

  one year from procedure

• Weight loss

  total weight loss and excess weight loss

  one year from procedure

Secondary Outcomes (5)

• Weight loss at 6 months

  at 6 months after the procedure (treatment group)

• More than 15% weight loss

  one year from procedure

• Quality of life

  one year from procedure

• TBWL

  one year from procedure

• Weight and height

  one year from procedure

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

Endoscopic sleeve gastroplasty (Endomina) at J0 with multidisciplinary follow-up for 1 year

Device: Endomina

Controled group

ACTIVE COMPARATOR

Diet for 6 months then Endoscopic sleeve gastroplasty (Endomina) with multidisciplinary follow-up for 1 year

Device: Endomina; Behavioral: Diet

Interventions

Endomina DEVICE

Endoscopic sleeve reduction

Controled group; Treatment group

Diet BEHAVIORAL

Multidisciplinary follow-up

Controled group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-65 years;
• Class I or class II obesity (i.e. BMI between 30 to 40 kg/m²);
• Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: clinical assessment, endoscopy, radiography, as well as laboratory investigations;
• Must be able to understand and be willing to provide written informed consent;
• Must live within 75 km of the treatment site;
• Had followed the bariatric multidisciplinary workup (blood analyses, dietician, psychologist and doctor appointments).

You may not qualify if:

• Achalasia and any other esophageal motility disorders;
• Severe esophagitis;
• Gastro-duodenal ulcer;
• Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
• Hypertension: uncontrolled hypertension during last 3 months;
• Diabetes: uncontrolled diabetes (on insulin therapy or oral therapy with Hba1c \> 10%);
• TBWL \>5% over the last 6 months;
• Severe renal, hepatic, pulmonary disease or cancer;
• GI stenosis or obstruction;
• Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months;
• Previous bariatric surgery, balloon or other endoscopic obesity-related therapy;
• Anticoagulant therapy;
• Impending gastric surgery 60 days post intervention;
• Currently participating in other study

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (2)

Gastroenterology Department Erasme Hospital

Brussels, 1070, Belgium

Location

APHM Hopital Marseille Nord Hepato-Gastroentérologie et Oncologie Digestive

Marseille, 13915, France

Location

Related Publications (10)

• ASGE Bariatric Endoscopy Task Force and ASGE Technology Committee; Abu Dayyeh BK, Kumar N, Edmundowicz SA, Jonnalagadda S, Larsen M, Sullivan S, Thompson CC, Banerjee S. ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointest Endosc. 2015 Sep;82(3):425-38.e5. doi: 10.1016/j.gie.2015.03.1964. Epub 2015 Jul 29.

  PMID: 26232362 RESULT

• Magro DO, Geloneze B, Delfini R, Pareja BC, Callejas F, Pareja JC. Long-term weight regain after gastric bypass: a 5-year prospective study. Obes Surg. 2008 Jun;18(6):648-51. doi: 10.1007/s11695-007-9265-1. Epub 2008 Apr 8.

  PMID: 18392907 RESULT

• Menchaca HJ, Harris JL, Thompson SE, Mootoo M, Michalek VN, Buchwald H. Gastric plication: preclinical study of durability of serosa-to-serosa apposition. Surg Obes Relat Dis. 2011 Jan-Feb;7(1):8-14. doi: 10.1016/j.soard.2010.11.002. Epub 2010 Nov 12.

  PMID: 21255733 RESULT

• Fogel R, De Fogel J, Bonilla Y, De La Fuente R. Clinical experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patients. Gastrointest Endosc. 2008 Jul;68(1):51-8. doi: 10.1016/j.gie.2007.10.061. Epub 2008 Mar 19.

  PMID: 18355825 RESULT

• Paxton JH, Matthews JB. The cost effectiveness of laparoscopic versus open gastric bypass surgery. Obes Surg. 2005 Jan;15(1):24-34. doi: 10.1381/0960892052993477.

  PMID: 15760496 RESULT

• Huberty V, Ibrahim M, Hiernaux M, Chau A, Dugardeyn S, Deviere J. Safety and feasibility of an endoluminal-suturing device for endoscopic gastric reduction (with video). Gastrointest Endosc. 2017 Apr;85(4):833-837. doi: 10.1016/j.gie.2016.08.007. Epub 2016 Aug 22.

  PMID: 27562938 RESULT

• ASGE Bariatric Endoscopy Task Force; ASGE Technology Committee; Abu Dayyeh BK, Edmundowicz SA, Jonnalagadda S, Kumar N, Larsen M, Sullivan S, Thompson CC, Banerjee S. Endoscopic bariatric therapies. Gastrointest Endosc. 2015 May;81(5):1073-86. doi: 10.1016/j.gie.2015.02.023. Epub 2015 Mar 28. No abstract available.

  PMID: 25828245 RESULT

• ASGE/ASMBS Task Force on Endoscopic Bariatric Therapy; Ginsberg GG, Chand B, Cote GA, Dallal RM, Edmundowicz SA, Nguyen NT, Pryor A, Thompson CC. A pathway to endoscopic bariatric therapies. Gastrointest Endosc. 2011 Nov;74(5):943-53. doi: 10.1016/j.gie.2011.08.053. No abstract available.

  PMID: 22032311 RESULT

• Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.

  PMID: 15479938 RESULT

• Huberty V, Boskoski I, Bove V, Van Ouytsel P, Costamagna G, Barthet MA, Deviere J. Endoscopic sutured gastroplasty in addition to lifestyle modification: short-term efficacy in a controlled randomised trial. Gut. 2020 Oct 28:gutjnl-2020-322026. doi: 10.1136/gutjnl-2020-322026. Online ahead of print.

  PMID: 33115727 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group A: treatment J0 + Diet 1 year Group B: Diet 6 months - Treatment - Diet 1 year

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 21, 2017
• Study Start: September 5, 2017
• Primary Completion: March 26, 2020
• Study Completion: March 26, 2020
• Last Updated: May 20, 2020

Record last verified: 2020-05

Locations

FR (1); BE (1)