Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2014
Longer than P75 for phase_3 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 17, 2014
CompletedFirst Posted
Study publicly available on registry
August 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedDecember 4, 2023
October 1, 2023
8.3 years
August 17, 2014
November 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lift Efficacy
Lifting characteristics which would be measured by height of the mucosa after submucosal gel injection.
1 hour
Secondary Outcomes (1)
Dissection Adequacy
1 hour
Study Arms (1)
Cook medical EMR Gel
EXPERIMENTALProspective 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.
Interventions
Cook Medical EMR Gel will be injected submucosally into ex-vivo gastric or colonic tissue specimens
Eligibility Criteria
You may qualify if:
- Pts undergoing sleeve gastrectomy
- Pts undergoing colectomy
You may not qualify if:
- Unable to give or understand consent
- All of the excised tissue will be needed for diagnostic purposes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Related 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.
PMID: 23392984BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danny Sherwinter, MD
Maimonides Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Administration Director
Study Record Dates
First Submitted
August 17, 2014
First Posted
August 10, 2015
Study Start
August 1, 2014
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
December 4, 2023
Record last verified: 2023-10