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

NCT ID: NCT02519140

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-01

Study Completion Date

2022-11-30

Brief Summary

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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

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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

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Gastric Cancer Colon Cancer

Keywords

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Gastric cancer colon cancer EMR biopsy bariatric surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cook Medical EMR Gel

Intervention Type DRUG

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

Interventions

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Cook Medical EMR Gel

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

Intervention Type DRUG

Other Intervention Names

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Cook Medical EMR Gel will be injected submucosally

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Antonios Likourezos

OTHER

Sponsor Role lead

Responsible Party

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Antonios Likourezos

Research Administration Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Danny Sherwinter, MD

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Locations

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Maimonides Medical Center

Brooklyn, New York, United States

Site Status

Countries

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United States

References

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Chandrasekhara V, Sigmon JC Jr, Surti VC, Kochman ML. A novel gel provides durable submucosal cushion for endoscopic mucosal resection and endoscopic submucosal dissection. Surg Endosc. 2013 Aug;27(8):3039-42. doi: 10.1007/s00464-013-2813-y. Epub 2013 Feb 8.

Reference Type BACKGROUND
PMID: 23392984 (View on PubMed)

Other Identifiers

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2014-05-06

Identifier Type: -

Identifier Source: org_study_id