Endoscopic Band Ligation for Treating Reflux Disease
Sponsor
El Katib Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06126055
Collaborator
Kasr El Aini Hospital (Other)
10
1
1
12
0.8
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The aim of the study is the complete resolution of reflux symptoms without the use of any drug.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
EndoBand: Endoscopic Band Ligation for Treating Reflux Disease (GERD)
Anticipated Study Start Date
:
Jan 1, 2024
Anticipated Primary Completion Date
:
Jan 1, 2025
Anticipated Study Completion Date
:
Jan 1, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Off PPI No symptoms of reflux |
Device: Band Ligation
Placing bands in distal esophagus
|
Outcome Measures
Primary Outcome Measures
- Endoscopic Band Ligation for GERD [1 month]
Resolution of reflux symptoms and stopping proton pump inhibitors.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Symptomatic GERD
Exclusion Criteria:
- Any previous surgery for GERD
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Endoscopy Unit Cairo University | Cairo | Egypt |
Sponsors and Collaborators
- El Katib Hospital
- Kasr El Aini Hospital
Investigators
- Principal Investigator: Mohamed Abeid, MD, Endoscopy Unit Faculty of Medicine Cairo University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mohamed Abeid,
Consultant Gastroenterologist,
El Katib Hospital
ClinicalTrials.gov Identifier:
NCT06126055
Other Study ID Numbers:
- GIELUKA
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohamed Abeid,
Consultant Gastroenterologist,
El Katib Hospital
Additional relevant MeSH terms: