Endomina Post RYGB

NCT03675035 | Completed DMC

• 1 other identifier: P2017/360
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Surgery is the only effective treatment for morbid obesity and can be divided into restrictive surgeries (Lap Band and Sleeve gastrectomy), malabsorptive surgeries (Biliary pancreatic deviation and duodenal switch) or a combination of both (RYGBP). This later technique is the most common and most effective surgical procedure performed worldwide and has been processed to be an effective treatment of morbid obesity and its complications, achieving excess weight loss of 65 to 80 % ; 1-2 years after surgery.1 However, after the initial weight loss induced by RYGBP; 50 % of patients regain some weight 2 and approximately 20 % of the patients will reach again a BMI of 35 at 10 years , defined as a failure rate.3 The reasons for weight regain are multiple but the most two potential contributing factors are related with the loss of the restrictive effect of the RYGBP by stretching of the gastric pouch and/or the gastrojejunal anastomosis (GJA), leading to increased satiety. Surgical options available for treating weight regain after RYGBP include placement of adjustable gastric band, Redo of the anastomosis or Reconstruction of the pouch.4 These procedures are technically difficult especially in patients who had previous single or multiple surgical interventions leading to a morbidity of around 15 % and a mortality of 1 %; Which is twice the one of the original surgery. This justifies the interest in less invasive, peroral revisions that include injection of sclerosant or suturing the anastomosis using Endoluminal gastroplication device (EndoCinch; Bard) 5,6 They have been however of marginal effectiveness compared to the medical treatment may be because their effect is limited to the anastomosis and doesn't reduce the size of the stretched gastric pouch. StomaphyX (Endogastric Solutions, Redmond, WA) is another systems aiming to reduce the gastric pouch has proved initial efficacy but are disappointing on the long term by a lack of persistence of the plicators. 7, 8 Endomina (Endo Tools Therapeutics, Nivelles, Belgium) is CE mark robot driven device that may be attached to an endoscope inside the body and allows remote manipulation of the arms of devices during a peroral intervention. It offers the possibilities of making transoral surgical full thickness sutures and may allow performing, via a transoral route, an intervention combining anastomoses reduction and gastric pouch reduction. It might be an effective treatment option for patients regaining weight after RYGBP and having a stretched pouch and or anastomosis.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Adeverse Device Effect

  Incidence of all adverse device effects

  6 months post intervention

Secondary Outcomes (1)

• Weight loss

  6 months post intervention

Study Arms (1)

Endomina

EXPERIMENTAL

Reduction trough sutures of the gastro-jejunal anastomosis

Device: Endomina

Interventions

Endomina DEVICE

Reduction of the gastro-jejunal anastomosis through sutures

Endomina

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 21-64 years;
• BMI \> 30 Kg/m2
• Previous gastric bypass with limited results
• 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.

You may not qualify if:

• Achalasia and any other esophageal motility disorders
• 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 month
• Severe renal, hepatic, pulmonary disease or cancer;
• GIT stenosis or obstruction
• Pregnancy or breastfeeding
• Impending gastric surgery 60 days post intervention;
• Currently participating in other study

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Gastroenterology Department Erasme Hospital

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: September 18, 2018
• Study Start: October 13, 2017
• Primary Completion: September 24, 2019
• Study Completion: September 24, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

BE (1)