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Endomina Post RYGB

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675035
Recruitment Status : Completed
First Posted : September 18, 2018
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Erasme University Hospital

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.


Condition or disease Intervention/treatment Phase
Obesity Device: Endomina Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 13, 2017
Actual Primary Completion Date : September 24, 2019
Actual Study Completion Date : September 24, 2019

Arm Intervention/treatment
Experimental: Endomina
Reduction trough sutures of the gastro-jejunal anastomosis
Device: Endomina
Reduction of the gastro-jejunal anastomosis through sutures




Primary Outcome Measures :
  1. Adeverse Device Effect [ Time Frame: 6 months post intervention ]
    Incidence of all adverse device effects


Secondary Outcome Measures :
  1. Weight loss [ Time Frame: 6 months post intervention ]
    difference between weight at intervention and after



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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675035


Locations
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Belgium
Gastroenterology Department Erasme Hospital
Brussels, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
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Responsible Party: Erasme University Hospital
ClinicalTrials.gov Identifier: NCT03675035    
Other Study ID Numbers: P2017/360
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No