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

Primary Purpose

Gastric Cancer, Colon Cancer

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cook Medical EMR Gel
Sponsored by
Maimonides Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, colon cancer, EMR, biopsy, bariatric surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Maimonides Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cook medical EMR Gel

Arm 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.

Outcomes

Primary Outcome Measures

Lift Efficacy
Lifting characteristics which would be measured by height of the mucosa after submucosal gel injection.

Secondary Outcome Measures

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

Full Information

First Posted
August 17, 2014
Last Updated
April 8, 2022
Sponsor
Maimonides Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02519140
Brief Title
Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections
Official Title
Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maimonides Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Colon Cancer
Keywords
Gastric cancer, colon cancer, EMR, biopsy, bariatric surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cook medical EMR Gel
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Cook Medical EMR Gel
Other Intervention Name(s)
Cook Medical EMR Gel will be injected submucosally
Intervention Description
Cook Medical EMR Gel will be injected submucosally into ex-vivo gastric or colonic tissue specimens
Primary Outcome Measure Information:
Title
Lift Efficacy
Description
Lifting characteristics which would be measured by height of the mucosa after submucosal gel injection.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Dissection Adequacy
Description
Dissection adequacy which would be measured by time which the gel stays within the tissues. Anything less than one hour will be considered failure.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danny A Sherwinter, MD
Phone
7182837952
Email
dsherwinter@maimonidesmed.org
First Name & Middle Initial & Last Name or Official Title & Degree
Julya Fuzaylova
Phone
7182837952
Email
jfuzaylova@maimonidesmed.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danny Sherwinter, MD
Organizational Affiliation
Maimonides Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danny A Sherwinter, MD
Phone
718-283-7952
Email
dsherwinter@maimonidesmed.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
23392984
Citation
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.
Results Reference
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Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections

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