NCT04431232

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2026

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

6.1 years

First QC Date

May 28, 2020

Last Update Submit

August 26, 2024

Conditions

Keywords

ObesityBMI

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    BMI Change

    3 months

Study Arms (1)

Band Ligation

EXPERIMENTAL

Band ligation of gastric body for weight loss

Device: Endoscopic Band Ligation

Interventions

Band ligation of the gastric body for weight loss

Band Ligation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \> 27

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El Katib Hospital (Celopatra Group)

Giza, Dokki, 12311, Egypt

RECRUITING

Related Publications (3)

  • 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.

    PMID: 23808945BACKGROUND
  • 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.

    PMID: 32001332BACKGROUND
  • 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.

    PMID: 30627991BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed Abeid, MD

    Endoscopy Unit Faculty of Medicine Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Abeid, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Gastroenterologist/ Bariatric Endoscopist Cairo University

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 16, 2020

Study Start

February 1, 2020

Primary Completion

March 7, 2026

Study Completion

March 7, 2026

Last Updated

August 27, 2024

Record last verified: 2024-08

Locations