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NCT04431232 Clinical Trial

Endo-Band: Endoscopic Band Ligation for Weight Loss

Obesity Clinical Trial

Official title:
Endoscopic Band Ligation for Weight Loss

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04431232
Other study ID # MohamedAbeid1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date March 7, 2024

Study information
Verified date March 2024
Source El Katib Hospital
Contact Mohamed Abeid, MD
Phone +201001222254
Email mohamedabeid@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 5
Est. completion date March 7, 2024
Est. primary completion date March 7, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - BMI > 27 Exclusion Criteria: - Any contraindication for endoscopy - Any gastric bleeding lesions - Uncontrolled use of anticoagulants or NSAID's

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Endoscopic Band Ligation
Band ligation of the gastric body for weight loss

Locations
Country Name City State
Egypt El Katib Hospital (Celopatra Group) Giza Dokki

Sponsors (1)
Lead Sponsor Collaborator
El Katib Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Weight Loss BMI Change 3 months
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