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Endomina Post RYGB

NCT03675035 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-01-22

No results posted yet for this study

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

Interventions

DEVICE

Endomina

Reduction of the gastro-jejunal anastomosis through sutures

Sponsors & Collaborators

  • Erasme University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-13
Primary Completion
2019-09-24
Completion
2019-09-24

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03675035 on ClinicalTrials.gov