Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System for the Treatment of Patients With Previously Untreated Dysplastic Barrett's Epithelium

Status: Active, not recruiting
Location: See all (11) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated (treatment naïve) Barrett's Esophagus (BE)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Low- or high-grade non-nodular, previously untreated (treatment naïve) dysplastic BE, confirmed by histopathological analysis. If nodular BE or Intramuscosal Cancer (ImCA) is identified during patient screening, this may be treated with Endoscopic Mucosal Resection (EMR) ≥6 weeks prior to treatment under this protocol. If previous EMR was performed, follow-up endoscopy must be negative for nodular BE. Patients with ImCA must be at low risk for recurrence, confirmed by EMR pathology results negative for positive margin, poorly differentiated carcinoma, and lymphovascular invasion.

• BE length ≤6cm excluding visible BE islands, and Prague Classification C ≥0 / M ≥1

• Older than 18 years of age at time of consent

• Operable per institution's standards

• Provides written informed consent on the approved informed consent form

• Willing and able to comply with study requirements for follow-up

Locations
United States
California
UC Irvine
Orange
Florida
Sarasota Memorial Hospital
Sarasota
Illinois
University of Chicago
Chicago
Maryland
John Hopkins
Baltimore
Minnesota
Mayo Clinic
Rochester
North Carolina
University of North Carolina School of Medicine
Chapel Hill
New York
Northwell Health
Manhasset
New York Presbyterian Hospital-Columbia University Medical Center
New York
Ohio
University Hospitals Cleveland Medical Center
Cleveland
Pennsylvania
Geisinger Medical Center
Danville
Thomas Jefferson University
Philadelphia
Time Frame
Start Date: March 2016
Estimated Completion Date: June 2023
Participants
Target number of participants: 150
Treatments
Other: CryoBalloon Ablation System
Cryoablation treatment of patients with previously untreated (treatment naïve) Barrett's epithelium.
Related Therapeutic Areas
Sponsors
Leads: Pentax Medical

This content was sourced from clinicaltrials.gov

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