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

NCT ID: NCT03843801

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2020-11-26

Brief Summary

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Volume reduction

Intragastric sutures are done to reduce the volume of the stomach

Group Type: ACTIVE_COMPARATOR

Endomina

Intervention Type: DEVICE

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.

Gastric emptying reduction

Intragastric sutures are done to slower the gastric emptying

Group Type: ACTIVE_COMPARATOR

Endomina

Intervention Type: DEVICE

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.

Increasing distension

Intragastric sutures are done to maximalize the gastric distension

Group Type: ACTIVE_COMPARATOR

Endomina

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CUB Hopital erasme

Anderlecht, , Belgium

Gastroenterology Department Erasme Hospital

Brussels, , Belgium

Countries

Belgium

Other Identifiers

CCB : / B406201838475

Identifier Type: -

Identifier Source: org_study_id