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

November 28, 2023 updated by: Antonios Likourezos
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Cook Medical EMR Gel
Cook Medical EMR Gel will be injected submucosally into ex-vivo gastric or colonic tissue specimens
Other Names:
  • Cook Medical EMR Gel will be injected submucosally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lift Efficacy
Time Frame: 1 hour
Lifting characteristics which would be measured by height of the mucosa after submucosal gel injection.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dissection Adequacy
Time Frame: 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.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antonios Likourezos

Investigators

  • Principal Investigator: Danny Sherwinter, MD, Maimonides Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

August 17, 2014

First Submitted That Met QC Criteria

August 7, 2015

First Posted (Estimated)

August 10, 2015

Study Record Updates

Last Update Posted (Actual)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-05-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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