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

Phase 3

Withdrawn

• Conditions: Gastric Cancer; Colon Cancer
• Interventions: Drug: Cook Medical EMR Gel

• Registration Number: NCT02519140
• Lead Sponsor: Antonios Likourezos

Brief 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.

Study Timeline

• Study Start: 2014-08-01
• Study First Submitted: 2014-08-17
• Study First Submitted QC: 2015-08-07
• Study First Posted: 2015-08-10
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Pts undergoing sleeve gastrectomy
• Pts undergoing colectomy

Exclusion Criteria

• Unable to give or understand consent
• All of the excised tissue will be needed for diagnostic purposes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cook medical EMR Gel	Cook Medical EMR Gel	Prospective study involving excised human stomachs and colon harvested from sleeve gastrectomies and colectomies performed for benign or malignant disease. Different Cook submucosal injections of varying viscosities will be injected into different areas of the excised stomachs or colons. Data collected will involve lifting characteristics and dissection adequacy of the varying viscosities of gel.

Primary Outcome Measures

Name	Time	Method
Lift Efficacy	1 hour	Lifting characteristics which would be measured by height of the mucosa after submucosal gel injection.

Secondary Outcome Measures

Name	Time	Method
Dissection Adequacy	1 hour	Dissection adequacy which would be measured by time which the gel stays within the tissues. Anything less than one hour will be considered failure.

Trial Locations

Locations (1)

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States