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Trial record 7 of 147 for:    barretts and mayo

Cryo Balloon for Residual Barrett's Esophagus (Cryoballoon)

This study is enrolling participants by invitation only.
C2 Therapeutics, Inc.
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic Identifier:
First received: August 27, 2014
Last updated: January 4, 2016
Last verified: January 2016
To assess the response of persistent Barrett's Esophagus and/or dysplasia to focal cyro ablation .

Condition Intervention Phase
Barrett's Esophagus
Device: CryoBalloon Focal Ablation
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CryoBalloon Focal Ablation System for Residual Barretts Esophagus Post Ablation; a Pilot Study.

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • eradication of barrett's esophagus and/or dysplasia [ Time Frame: 3 to 6 months post treatment ] [ Designated as safety issue: No ]
    Surveillance endoscopy with 4-quadrant biopsies every 1 cm from the gastric cardia, proceeding proximally at the length of the original BE lesion/s will be performed per standard clinical practice at 3 or 6 months post ablation. The presence of Barrett's Esophagus and degree of dysplasia will be confirmed by histopathologic diagnosis

Estimated Enrollment: 10
Study Start Date: August 2014
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: focal cryo ablation
in this pilot study 10 subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment
Device: CryoBalloon Focal Ablation

Detailed Description:
Observational study of patients undergoing clinically indicated focal cryo ablation

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Eligible patients for enrollment in this study must fulfill all of the following criteria:

  1. Age > 18 years old
  2. Able to provide informed consent
  3. Patients with unifocal or multifocal BE with 2 cm who have failed at least 2 serial RFA or other endoscopic therapy such as Endoscopic Mucosal resection,

Exclusion from the study with any of the following:

  1. Age younger than 18 years old
  2. Presence of esophageal varices
  3. Esophageal stricture precluding passage of an endoscope
  4. Inability to provide informed consent
  5. Esophageal cancer (T2 and above)
  6. Coagulopathy with INR > 2.0, thrombocytopenia with platelet counts < 50,000
  7. pregnancy (if required a pregnancy test would be performed as part of routine clinical care)
  Contacts and Locations
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Please refer to this study by its identifier: NCT02230410

United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
C2 Therapeutics, Inc.
Principal Investigator: Kenneth Wang, MD Mayo Clinic
  More Information

Additional Information:
Responsible Party: Kenneth K. Wang, VanCleve Professor of Gastroenterology Reserach, Mayo Clinic Identifier: NCT02230410     History of Changes
Other Study ID Numbers: 14-004771 
Study First Received: August 27, 2014
Last Updated: January 4, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
high grade dysplasia

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases processed this record on October 21, 2016