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Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections
Phase 3
Waitlist Available
Led By Danny Sherwinter, MD
Research Sponsored by Antonios Likourezos
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing a special gel to see how its thickness affects the ease of a specific type of surgery. The gel is injected under the tissue to lift it, making the surgery easier. The study uses tissues from routine surgeries to simulate real conditions.
Eligible Conditions
- Stomach Cancer
- Colon Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Lift Efficacy
Secondary study objectives
Dissection Adequacy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cook medical EMR GelExperimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
Antonios LikourezosLead Sponsor
40 Previous Clinical Trials
8,634 Total Patients Enrolled
Maimonides Medical CenterLead Sponsor
71 Previous Clinical Trials
15,510 Total Patients Enrolled
Danny Sherwinter, MDPrincipal InvestigatorMaimonides Medical Center
3 Previous Clinical Trials
117 Total Patients Enrolled