Endomina Controlled Study

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Device: Endomina; Behavioral: Diet

• Registration Number: NCT03255005
• Lead Sponsor: Erasme University Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-21
• Study Start: 2017-09-05
• Primary Completion: 2020-03-26
• Study Completion: 2020-03-26
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Controled group	Endomina	Diet for 6 months then Endoscopic sleeve gastroplasty (Endomina) with multidisciplinary follow-up for 1 year
Controled group	Diet	Diet for 6 months then Endoscopic sleeve gastroplasty (Endomina) with multidisciplinary follow-up for 1 year
Treatment group	Endomina	Endoscopic sleeve gastroplasty (Endomina) at J0 with multidisciplinary follow-up for 1 year

Primary Outcome Measures

Name	Time	Method
Incidence of all Adverse Device Effects	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.
Weight loss	one year from procedure	total weight loss and excess weight loss

Secondary Outcome Measures

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

Trial Locations

Locations (2)

APHM Hopital Marseille Nord Hepato-Gastroentérologie et Oncologie Digestive; 🇫🇷 Marseille, France

Gastroenterology Department Erasme Hospital; 🇧🇪 Brussels, Belgium