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A Prospective Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina TM) as an Aid for Endoscopic Gastric Reduction.

NCT02582229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-09-13

No results posted yet for this study

Summary

Surgery is 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 later 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 (1,2).

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 (3,4).

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 (5).

Conditions

Interventions

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 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.

Sponsors & Collaborators

  • Erasme University Hospital

    lead OTHER

Principal Investigators

  • Jacques Deviere, MD,PhD · Hopital Erasme, Gastroenterology Department

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Belgium
  • Czechia
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02582229 on ClinicalTrials.gov