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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02519140
• Other study ID #: 2014-05-06
• Status: Withdrawn
• Phase: Phase 3
• Start date: August 1, 2014
• Est. completion date: November 30, 2022

Study information

• Verified date: October 2023
• Source: Maimonides Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Antonios Likourezos

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lift Efficacy	Lifting characteristics which would be measured by height of the mucosa after submucosal gel injection.	1 hour
Secondary	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.	1 hour