Endoscopic Band Ligation for Treating Reflux Disease | NCT06126055

Studies
Endoscopic Band Ligation for Treating Reflux Disease

NCT06126055

Sponsor

El Katib Hospital

Status

Not yet recruiting

Last Update Posted

Aug 8, 2025Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

GERD

Interventions

Band Ligation

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2025Estimated

Primary Completion Date

Dec 1, 2027Estimated

Completion Date

Dec 1, 2027Estimated

First Submitted Date

Nov 3, 2023

First Submission Date that Met QC Criteria

Nov 8, 2023

First Posted Date

Nov 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2025

Last Update Posted Date

Aug 8, 2025Actual

Name	Class
Kasr El Aini Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Off PPI	Experimental	No symptoms of reflux	Device: Band Ligation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Band Ligation	Device	Placing bands in distal esophagus	Off PPI

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptomatic GERD

Exclusion Criteria:

Any previous surgery for GERD

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed Abeid, MD	Contact	+201001222254		mohamedabeid@gmail.com

Overall Officials

Name	Affiliation	Role
Mohamed Abeid, MD	Endoscopy Unit Faculty of Medicine Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Endoscopy Unit Cairo University		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Yes

Types

Study Protocol

Time Frame

1 year

Access Criteria

Free

URL

http://www.MohamedAbeid.com

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided