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

Antonios Likourezos

Status and phase: Withdrawn; Phase 3

Conditions: Gastric Cancer; Colon Cancer

Treatments: Drug: Cook Medical EMR Gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02519140

2014-05-06

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Cook medical EMR Gel

Experimental group

Description:

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.

Treatment:

Drug: Cook Medical EMR Gel