Endoscopic Band Ligation for Treating Reflux Disease

March 7, 2024 updated by: Mohamed Abeid, El Katib Hospital

EndoBand: Endoscopic Band Ligation for Treating Reflux Disease (GERD)

GERD is a chronic disease the require different treatment modalities; non have proven long term efficacy with concerns about their safety. The use of band ligation in endoscopy appears safe, repeatable with short learning curve. Placing multiple bands at the Z-line can create a fibrous ring in the distal esophagus acting as a barrier against reflux of gastric content.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of the study is the complete resolution of reflux symptoms without the use of any drug.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Endoscopy Unit Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Symptomatic GERD

Exclusion Criteria:

  • Any previous surgery for GERD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Off PPI
No symptoms of reflux
Device: Band Ligation
Placing bands in distal esophagus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic Band Ligation for GERD
Time Frame: 1 month
Resolution of reflux symptoms and stopping proton pump inhibitors.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

El Katib Hospital

Collaborators

Kasr El Aini Hospital

Investigators

  • Principal Investigator: Mohamed Abeid, MD, Endoscopy Unit Faculty of Medicine Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

November 3, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIELUKA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Yes

IPD Sharing Time Frame

1 year

IPD Sharing Access Criteria

Free

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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