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

NCT02534662 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-04-27

No results posted yet for this study

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

Interventions

DEVICE

ENDOMINA

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

  • Theodor Bilharz Research Institute

    lead OTHER

Principal Investigators

  • Jacques Deviere, PHD · Université Libre de Bruxelles

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
2015-05-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Belgium

Study Locations

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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 NCT02534662 on ClinicalTrials.gov