A Prospective Study to Evaluate the Suture Pattern With the Endomina Suturing Device for Endoscopic Sutured Gastroplasty (ESG). (Pattern)

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 (1).

Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is CE mark device that may be attached to an endoscope inside the body and allows remote manipulation of the arms of the device during a peroral intervention. It offers the possibilities of making transoral surgical full thickness sutures and may allow performing endoscopic therapeutic interventions, via a transoral route.

A first trial including 11 patients assessed feasibility and safety of the technique (2). There were no complications and the short-term results were encouraging. Then a multicentric efficacy study was conducted, including 51 patients (3). The results where EWL of 31% at one year and TBWL of 9% without complications.

Finally a randomized controlled study was done including 73 patients in a 2/1 randomized fashion with a crossover at 6 months. Treated group was with the endomina device and controlled group was diet only. The follow-up was the same in each group. Primary endpoint was to reach the ASGE guideline "difference between a control group and a treatment group of minimum 15%" (4).

Technique and suture pattern have evolved since the first study. The aim of this prospective evaluation is to compare different suture patterns and their mechanism of action.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Device: Endomina

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Anderlecht, Belgium, 1070
    • CUB Hôpital Erasme
  • Brussels, Belgium, 1070
    • Gastroenterology Department Erasme Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age between 18-64 years;
2. 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, gastric emptying scintigraphy, satiety test, as well as laboratory investigations.
4. Must be able to understand and be willing to provide written informed consent.
5. Must have completed the multidisciplinary workup

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. GI stenosis or obstruction
6. Pregnancy or breastfeeding or willing to become pregnant within study duration
7. History of gastric surgery (any type)
8. Impending gastric surgery 60 days post intervention
9. History of weight changes (±5% TBWL) within the previous 6 months
10. Placement/removal of an intragastric balloon in less than 6 months
11. Currently participating in other study
12. HP positive

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Volume reduction; Intragastric sutures are done to reduce the volume of the stomach	Device: Endomina; The intervention will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of transmural anterior-posterior sutures in the stomach in order to achieve a gastric remodelling. Patient will be kept overnight after the procedure.
ACTIVE_COMPARATOR: Gastric emptying reduction; Intragastric sutures are done to slower the gastric emptying	Device: Endomina; The intervention will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of transmural anterior-posterior sutures in the stomach in order to achieve a gastric remodelling. Patient will be kept overnight after the procedure.
ACTIVE_COMPARATOR: Increasing distension; Intragastric sutures are done to maximalize the gastric distension	Device: Endomina; The intervention will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of transmural anterior-posterior sutures in the stomach in order to achieve a gastric remodelling. Patient will be kept overnight after the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	no difference in weight loss between groups	one year from procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric emptying	Evaluation of the correlation between gastric emptying scintigraphy results and the suture pattern related to motility disruption	one year from procedure
Satiety test assessed by the correlation between satiety test and the suture pattern related to volume reduction	Evaluation of the correlation between satiety test and the suture pattern related to volume reduction	one year from procedure
sutures	Evaluation of the correlation between the number of remaining sutures (with gastric remodeling) and weight loss	one year from procedure
Excess weight loss	Percentage of patients, total and per group, reaching ASGE guidelines of 25% Excess weight loss at 1-year	one year from procedure

Collaborators and Investigators

• Sponsor: Erasme University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 2, 2019
• Primary Completion (ACTUAL): November 26, 2020
• Study Completion (ACTUAL): November 26, 2020

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (ACTUAL): February 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Endoscopy; Mini invasive
• Other Study ID Numbers: CCB : / B406201838475

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No