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Procedure

Cryotherapy for Barrett's Esophagus and Early Esophageal Cancers

Phase < 1
Waitlist Available
Led By John A. Dumot, D.O.
Research Sponsored by Case Comprehensive Cancer Center
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 at 12 months from start of therapy
Awards & highlights
No Placebo-Only Group

Summary

This is a single center study to evaluate the efficacy and safety of a new ablation technique involving the spray of liquid nitrogen through a catheter (cryotherapy) via an upper endoscopy (EGD) to ablate Barrett's esophagus with changes of high-grade dysplasia (HGD) or intramucosal cancer (IMCA) and patients with esophageal cancer limited to the esophageal wall, in whom there are no standard treatment options available.

Eligible Conditions
  • Barrett's Esophagus
  • Esophageal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months from start of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months from start of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients that achieved successful ablation of dysplasia and neoplasia Barrett's Esophagus.
Number of patients that experience toxicity with cryotherapy
Secondary study objectives
Assess the degree of tumor ablation of inoperable early esophageal cancer

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Barrett's Esophagus with intramucosal carcinoma (IMCA)Experimental Treatment1 Intervention
Group II: Barrett's Esophagus with High Grade Dysplasia (HGD)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryospray Ablation
2005
Completed Early Phase 1
~40

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
469 Previous Clinical Trials
33,433 Total Patients Enrolled
John A. Dumot, D.O.Principal InvestigatorThe Cleveland Clinic
~2 spots leftby Jan 2026
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