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Endo-Band: Endoscopic Band Ligation for Weight Loss

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endoscopic Band Ligation
Sponsored by
El Katib Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, BMI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI > 27

Exclusion Criteria:

  • Any contraindication for endoscopy
  • Any gastric bleeding lesions
  • Uncontrolled use of anticoagulants or NSAID's

Sites / Locations

  • El Katib Hospital (Celopatra Group)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Band Ligation

Arm Description

Band ligation of gastric body for weight loss

Outcomes

Primary Outcome Measures

Weight Loss
BMI Change

Secondary Outcome Measures

Full Information

First Posted
May 28, 2020
Last Updated
November 29, 2022
Sponsor
El Katib Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04431232
Brief Title
Endo-Band: Endoscopic Band Ligation for Weight Loss
Official Title
Endoscopic Band Ligation for Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
March 7, 2024 (Anticipated)
Study Completion Date
March 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
El Katib Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To the best of our knowledge, this is the first study to use endoscopic band ligation for weight loss. All ligatures will be performed in the gastric body starting at the distal body; 5 parallel rows, with the last one in the proximal body.The entire procedure can be completed in 30 min. Oxygen is used for endoscopic air insufflation.Endoscopy is performed using propofol for sedation.
Detailed Description
The idea of band ligation of the gastric body is to induce multiple gastric ulcers that forms a fibrotic scars which can lead to marginal narrowing of the lumen; same as that occurred in the esophagus following band ligation of esophageal varices or in the antrum following band ligation of GAVE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, BMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Band Ligation
Arm Type
Experimental
Arm Description
Band ligation of gastric body for weight loss
Intervention Type
Device
Intervention Name(s)
Endoscopic Band Ligation
Intervention Description
Band ligation of the gastric body for weight loss
Primary Outcome Measure Information:
Title
Weight Loss
Description
BMI Change
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI > 27 Exclusion Criteria: Any contraindication for endoscopy Any gastric bleeding lesions Uncontrolled use of anticoagulants or NSAID's
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Abeid, MD
Phone
+201001222254
Email
mohamedabeid@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Abeid, MD
Organizational Affiliation
Endoscopy Unit Faculty of Medicine Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
El Katib Hospital (Celopatra Group)
City
Giza
State/Province
Dokki
ZIP/Postal Code
12311
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Abeid, MD
Phone
01001222254
Email
mohamedabeid@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
23808945
Citation
Keohane J, Berro W, Harewood GC, Murray FE, Patchett SE. Band ligation of gastric antral vascular ectasia is a safe and effective endoscopic treatment. Dig Endosc. 2013 Jul;25(4):392-6. doi: 10.1111/j.1443-1661.2012.01410.x. Epub 2012 Dec 17.
Results Reference
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PubMed Identifier
32001332
Citation
Jirapinyo P, Thompson CC. Endoscopic gastric body plication for the treatment of obesity: technical success and safety of a novel technique (with video). Gastrointest Endosc. 2020 Jun;91(6):1388-1394. doi: 10.1016/j.gie.2020.01.030. Epub 2020 Jan 28.
Results Reference
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PubMed Identifier
30627991
Citation
Abeid M, Miller KA, Kaddah T, Zaitoun N. Outcome of Primary Obesity Surgery Endolumenal Procedure as Obesity Treatment in Private Practice Setting: an Intervention Study. Obes Surg. 2019 Apr;29(4):1364-1366. doi: 10.1007/s11695-018-03698-z. No abstract available.
Results Reference
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Endo-Band: Endoscopic Band Ligation for Weight Loss

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