Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Endo-Band: Endoscopic Band Ligation for Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04431232
Recruitment Status : Suspended (Due to COVID-19 pandemic)
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Abeid, El Katib Hospital

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.

Condition or disease Intervention/treatment Phase
Obesity Device: Endoscopic Band Ligation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Band Ligation for Weight Loss
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : March 7, 2021
Estimated Study Completion Date : March 7, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Band Ligation
Band ligation of gastric body for weight loss
Device: Endoscopic Band Ligation
Band ligation of the gastric body for weight loss




Primary Outcome Measures :
  1. Weight Loss [ Time Frame: 3 months ]
    BMI Change



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI > 27

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04431232


Locations
Layout table for location information
Egypt
El Katib Hospital (Celopatra Group)
Giza, Dokki, Egypt, 12311
Sponsors and Collaborators
El Katib Hospital
Investigators
Layout table for investigator information
Principal Investigator: Mohamed Abeid, MD Endoscopy Unit Faculty of Medicine Cairo University
Publications:
Layout table for additonal information
Responsible Party: Mohamed Abeid, Consultant Gastroenterologist/ Bariatric Endoscopist Cairo University, El Katib Hospital
ClinicalTrials.gov Identifier: NCT04431232    
Other Study ID Numbers: MohamedAbeid1
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Abeid, El Katib Hospital:
Obesity
BMI
Additional relevant MeSH terms:
Layout table for MeSH terms
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes