NCT02519140

Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Antonios Likourezos · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a study to determine how the viscosity (thickness) of an FDA approved gel affects the ease in which endoscopic mucosal resections (EMR) can be performed.

Detailed description

This is a study to determine how the viscosity (thickness) of an FDA approved gel made by Cook medical affects the ease in which endoscopic mucosal resections (EMR) - a type of endoscopic surgery performed for localised cancer - can be performed when the gel is injected submucosally. The lifting characteristics of the gel will be assessed by height and diameter and ease with which the subsequent EMR dissection can be performed. These characteristics would be assessed on excised human stomachs and colon, which are harvested during routine sleeve gastrectomy surgeries or colectomies, in an ex-vivo manner.

Conditions

• Gastric Cancer
• Colon Cancer

Interventions

Type	Name	Description
DRUG	Cook Medical EMR Gel	Cook Medical EMR Gel will be injected submucosally into ex-vivo gastric or colonic tissue specimens

Timeline

• Start date: 2014-08-01
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2015-08-10
• Last updated: 2023-12-04

Locations

1 site across 1 country: United States