NCT03843801

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-02
• Primary completion: 2020-11-26
• Completion: 2020-11-26
• First posted: 2019-02-18
• Last updated: 2021-03-02

Locations

2 sites across 1 country: Belgium