Safety and Feasibility of an Endoluminal-suturing Device (Endomina TM) for Gastric Reduction

NCT02534662 | Completed DMC

• 1 other identifier: ENDOMINA
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: Study to evaluate safety and feasibility of an endoluminal vertical gastroplasty (EVG) using an endoluminal-suturing device. Briefly, 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 (ie, 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. Study duration and number of subjects A period of approximately 6 months is anticipated form the time the time the first patient is enrolled to the completion of the last patient. The participants will be followed as follow: Day (0): Procedure Day (+1): Clinical Follow up and discharge (i.e. if no adverse effects observed) 1 month: Follow up endoscopy, Clinical assessment 3 month: Follow up endoscopy, Clinical assessment 6 month: Final assessment (Endoscopically and Clinical) On Parallel a nutritional specialist will monitor the patient on quarterly basis (1,3,6,12). Study procedures 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 4-6 transmural anterior-posterior sutures after argon plasma coagulation of the tissue opposition areas in order to ensure persistence of the pouch reduction. Patient will be kept overnight after the procedure.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Safety characterized by the incidence of all Adverse Device Effects (ADEs), physical examination (vital signs), laboratory tests, and subsequent adverse events

  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. In addition, safety assessments will be determined based on physical examination (vital signs) and laboratory tests during scheduled visits. Safety evaluations will also be performed to ensure no subsequent adverse events have occurred and to ensure any adverse events during the trial that are considered on-going are stable or have resolved. Safety will be assessed at 1 and 6 month following the intervention.

  12 month

Secondary Outcomes (1)

• Feasibility assessment obtained by measurements of total weight loss and excess weight loss

  12 month

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of 4-6 transmural anterior-posterior sutures after argon plasma coagulation of the tissue opposition areas in order to ensure persistence of the pouch reduction. Patient will be kept overnight after the procedure.

Device: ENDOMINA

Interventions

ENDOMINA DEVICE

Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of 4-6 transmural anterior-posterior sutures after argon plasma coagulation of the tissue opposition areas in order to ensure persistence of the pouch reduction. Patient will be kept overnight after the procedure.

Treatment Arm

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 21-64 years;
• BMI \> 40 Kg/m2 or BMI \>35 Kg/m2 with comorbidities
• 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.
• Must be able to understand and be willing to provide written informed consent.

You may not qualify if:

• Achalasia and any other esophageal motility disorders
• 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.
• Hypertension: uncontrolled hypertension during last 3 month
• Severe renal, hepatic, pulmonary disease or cancer;
• GIT stenosis or obstruction
• Pregnancy or breastfeeding
• Impending gastric surgery 60 days post intervention;
• Currently participating in other study

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Erasme Hospital , ULB

Brussels, 1070, Belgium

Location

Related Publications (1)

• Huberty V, Ibrahim M, Hiernaux M, Chau A, Dugardeyn S, Deviere J. Safety and feasibility of an endoluminal-suturing device for endoscopic gastric reduction (with video). Gastrointest Endosc. 2017 Apr;85(4):833-837. doi: 10.1016/j.gie.2016.08.007. Epub 2016 Aug 22.

  PMID: 27562938 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacques Deviere, PHD

  Université Libre de Bruxelles

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology and Hepatopancreatology Physician

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: August 28, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)