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Endomina Suturing Device as a Treatment of GERD.

NCT03999502 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-03-02

No results posted yet for this study

Summary

Gastroesophageal Reflux Disease (GERD) is a common problem affecting 10-20% of the population in the Western World.

Surgical therapy is able to restore the EGJ barrier function against reflux of the gastric content, decreases symptoms and improves the quality of life in GERD patients. However, there remain concerns regarding postoperative adverse events and the durability of the surgical procedure.

The ability to perform endoscopic full-thickness plications with Endomina-v2 will be used to assess safety and feasibility of the procedure in reducing GERD in patients suffering with chronic GERD, unsatisfied with PPIs, and/or complaining of persistent GERD symptoms despite PPI use.

Conditions

  • GERD

Interventions

DEVICE

Endomina

The procedure will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over a guidewire and then fixed to the endoscope. The procedure will include at least one suture of the gastric cardia to tighten it. Patients will be kept overnight after the procedure.

Sponsors & Collaborators

  • Erasme University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-15
Primary Completion
2021-05-12
Completion
2022-05-12

Countries

  • Belgium

Study Locations

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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 NCT03999502 on ClinicalTrials.gov