Endomina Post RYGB

Obesity Clinical Trial

Official title:

A Prospective Study to Evaluate the Safety and Feasibility of an Endoluminal Suturing Device (Endominav2Mini) as an Aid for Pouch Reduction After Roux-And-Y-Gastric-Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03675035
• Other study ID #: P2017/360
• Status: Completed
• Phase: N/A
• Start date: October 13, 2017
• Est. completion date: September 24, 2019

Study information

• Verified date: January 2020
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 24, 2019
• Est. primary completion date: September 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

Inclusion Criteria:

1. Age between 21-64 years;

2. BMI > 30 Kg/m2

3. Previous gastric bypass with limited results

4. 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.

5. Must be able to understand and be willing to provide written informed consent.

Exclusion Criteria:

1. Achalasia and any other esophageal motility disorders

2. 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.

3. Hypertension: uncontrolled hypertension during last 3 month

4. Severe renal, hepatic, pulmonary disease or cancer;

5. GIT stenosis or obstruction

6. Pregnancy or breastfeeding

7. Impending gastric surgery 60 days post intervention;

8. Currently participating in other study

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Endomina
Reduction of the gastro-jejunal anastomosis through sutures

Locations

Country	Name	City	State
Belgium	Gastroenterology Department Erasme Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adeverse Device Effect	Incidence of all adverse device effects	6 months post intervention
Secondary	Weight loss	difference between weight at intervention and after	6 months post intervention