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Trial record 5 of 79 for:    barretts and mayo

Cryo Balloon for Residual Barrett's Esophagus (Cryoballoon)

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ClinicalTrials.gov Identifier: NCT02230410
Recruitment Status : Enrolling by invitation
First Posted : September 3, 2014
Last Update Posted : February 12, 2018
Sponsor:
Collaborator:
C2 Therapeutics, Inc.
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic

Brief Summary:
To assess the response of persistent Barrett's Esophagus and/or dysplasia to focal cyro ablation .

Condition or disease Intervention/treatment Phase
Barrett's Esophagus Device: CryoBalloon Focal Ablation Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CryoBalloon Focal Ablation System for Residual Barretts Esophagus Post Ablation; a Pilot Study.
Study Start Date : August 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. eradication of barrett's esophagus and/or dysplasia [ Time Frame: 3 to 6 months post treatment ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02230410


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

Additional Information:
Responsible Party: Kenneth K. Wang, VanCleve Professor of Gastroenterology Reserach, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02230410     History of Changes
Other Study ID Numbers: 14-004771
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018

Keywords provided by Kenneth K. Wang, Mayo Clinic:
Barrett's
high grade dysplasia
ablation
cyrotherapy

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases