Cook Medical EMR Gel for Stomach Cancer

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour for reporting.

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.

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