- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04431232
Endo-Band: Endoscopic Band Ligation for Weight Loss
March 7, 2024 updated by: Mohamed Abeid, El Katib Hospital
Endoscopic Band Ligation for Weight Loss
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Estimated)
5
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
- Name: Mohamed Abeid, MD
- Phone Number: +201001222254
- Email: mohamedabeid@gmail.com
Study Locations
-
-
Dokki
-
Giza, Dokki, Egypt, 12311
- Recruiting
- El Katib Hospital (Celopatra Group)
-
Contact:
- Mohamed Abeid, MD
- Phone Number: 01001222254
- Email: mohamedabeid@gmail.com
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- BMI > 27
Exclusion Criteria:
- Any contraindication for endoscopy
- Any gastric bleeding lesions
- Uncontrolled use of anticoagulants or NSAID's
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: Band Ligation
Band ligation of gastric body for weight loss
|
Band ligation of the gastric body for weight loss
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight Loss
Time Frame: 3 months
|
BMI Change
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohamed Abeid, MD, Endoscopy Unit Faculty of Medicine Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
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 (Actual)
February 1, 2020
Primary Completion (Estimated)
March 7, 2024
Study Completion (Estimated)
March 7, 2024
Study Registration Dates
First Submitted
May 28, 2020
First Submitted That Met QC Criteria
June 11, 2020
First Posted (Actual)
June 16, 2020
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- MohamedAbeid1
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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