Endomina Controlled Study

May 19, 2020 updated by: Erasme University Hospital

A Controlled Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) as an Aid for Endoscopic Gastric Reduction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Surgery is currently 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 latter 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.

Vertical gastric plication is a novel surgical approach for reducing the stomach capacity. Anterior surface plication and greater curvature plication are variations of vertical gastric plication that reduce the gastric capacity through infolding of the anterior surface or greater curvature of the stomach, respectively. These approaches have been tested, with positive results.

A transoral or endoluminal approach (i.e. a procedure that requires no incision, because access is granted through the mouth) offers the potential for additional benefit to the patient, because the procedures continue to become more and more minimally invasive.

Advances in endoluminal devices are now allowing clinicians the ability to begin exploring bariatric procedures performed via flexible endoscopy. Although these procedures may not be as effective as their surgical counterparts, these less-invasive options may relieve patients of the significant risks associated with surgery and might become part of the armamentarium of obesity management.

Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is a CE marked device that may be attached to an endoscope inside the body and allows remote actuation of the device during a peroral intervention. It offers the possibilities of making transoral full thickness tissue apposition and may allow performing, via a transoral route, large plications with tight serosa to serosa apposition.

After a first trial on pigs (safety), a second trial on human patients was performed. This trial included 11 patients treated with the same technique. There were no complications and the short term results were encouraging with 41% EWL at 6 month.

A multicentric trial NCT02582229 entitled: " A Prospective Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina TM) as an Aid for Endoscopic Gastric Reduction. " is ongoing and inclusion of patients ended in December 2016 with a total of 51 patients included in 3 European centers. Early results of the trial had showed that dietician follow-up is an important part of the success. During that time implementation of the procedure had been done.

The aim of this trial is to compare a control group (diet alone) with a treatment group (Endomina procedure plus diet).

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Gastroenterology Department Erasme Hospital
  • France
      • Marseille, France, 13915
        • APHM Hopital Marseille Nord Hepato-Gastroentérologie et Oncologie Digestive

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 18-65 years;
  2. Class I or class II obesity (i.e. BMI between 30 to 40 kg/m²);
  3. 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;
  4. Must be able to understand and be willing to provide written informed consent;
  5. Must live within 75 km of the treatment site;
  6. Had followed the bariatric multidisciplinary workup (blood analyses, dietician, psychologist and doctor appointments).

Exclusion Criteria:

  1. Achalasia and any other esophageal motility disorders;
  2. Severe esophagitis;
  3. Gastro-duodenal ulcer;
  4. 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;
  5. Hypertension: uncontrolled hypertension during last 3 months;
  6. Diabetes: uncontrolled diabetes (on insulin therapy or oral therapy with Hba1c > 10%);
  7. TBWL >5% over the last 6 months;
  8. Severe renal, hepatic, pulmonary disease or cancer;
  9. GI stenosis or obstruction;
  10. Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months;
  11. Previous bariatric surgery, balloon or other endoscopic obesity-related therapy;
  12. Anticoagulant therapy;
  13. Impending gastric surgery 60 days post intervention;
  14. Currently participating in other study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment group
Endoscopic sleeve gastroplasty (Endomina) at J0 with multidisciplinary follow-up for 1 year
Device: Endomina
Endoscopic sleeve reduction
Active Comparator: Controled group
Diet for 6 months then Endoscopic sleeve gastroplasty (Endomina) with multidisciplinary follow-up for 1 year
Device: Endomina
Endoscopic sleeve reduction
Behavioral: Diet
Multidisciplinary follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of all Adverse Device Effects
Time Frame: one year from procedure
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
Time Frame: one year from procedure
total weight loss and excess weight loss
one year from procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss at 6 months
Time Frame: at 6 months after the procedure (treatment group)
comparison between diet and treatment group at 6 months
at 6 months after the procedure (treatment group)
More than 15% weight loss
Time Frame: one year from procedure
Proportion of patients in the Endomina Group with a loss of weight of more than 15%
one year from procedure
Quality of life
Time Frame: one year from procedure
SF36
one year from procedure
TBWL
Time Frame: one year from procedure
Mean % total body weight loss (%TBWL)
one year from procedure
Weight and height
Time Frame: one year from procedure
To calculate the body mass index (BMI)
one year from procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasme University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2017

Primary Completion (Actual)

March 26, 2020

Study Completion (Actual)

March 26, 2020

Study Registration Dates

First Submitted

August 8, 2017

First Submitted That Met QC Criteria

August 16, 2017

First Posted (Actual)

August 21, 2017

Study Record Updates

Last Update Posted (Actual)

May 20, 2020

Last Update Submitted That Met QC Criteria

May 19, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P2017/401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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