Text Size

Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Chek-Med Systems, Inc.
Information provided by (Responsible Party):
Herbert C. Wolfsen, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01477177
First received: October 24, 2011
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this pilot study is to provide an initial assessment of the feasibility, safety and efficacy of Polar Wand carbon dioxide cryotherapy for treatment of Barrett's low grade and high grade dysplasia by use in a small number of patients so as to support, or otherwise, the development of a full-scale trial.


Condition Intervention
Barrett's Esophagus
 Device: Polar Wand carbon dioxide cryotherapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus With Low Grade and High Grade Dysplasia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Reduction in Barrett's histology grade, using the modified Vienna classification [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The reduction of Barrett's segment length and histology classification will be measured at 12 months.


Secondary Outcome Measures:
  • Reduction in Barrett's segment length, using the Prague classification [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Assessment of complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Specific complications are GI Bleeding and Perforation and Stricture and Ulceration

  • Assessment of post-ablation symptoms [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Specific symptoms (frequency and severity) are chest pain, difficulty swallowing, painful swallowing, nausea or vomiting, sore throat

  • Reduction in Barrett's histology grade, using the modified Vienna classification [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The reduction of Barrett's segment length and histology classification will be measured at 6 months.


Estimated Enrollment: 14
Study Start Date: August 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Polar Wand Treatment
Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia
 Device: Polar Wand carbon dioxide cryotherapy
Patients with Barrett's esophagus dysplasia will be treated with the Polar Wand device at 0 month, 2 and 4 months,6 months (with four quadrant surveillance biopsies), 8 and 10 months (treatment as necessary), and, at 12 months for final surveillance with biopsies throughout entire initial Barrett's segment length.

Detailed Description:

Prospective pilot study to be performed in 14 Barrett's Esophagus patients with low grade and high grade dysplasia, referred for standard of care treatment. Patients will receive treatments with carbon dioxide Polar Wand cryotherapy at 0, 2 and 4 months, followed by surveillance endoscopy with four quadrant biopsies throughout the entire Barrett's esophagus (BE)segment at 6 months, followed by endoscopy with additional treatments (if needed) at 8 and 10 months, followed by a final surveillance endoscopy at 12 months, with four quadrant biopsies throughout the entire initial BE segment length.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients referred for treatment with Barrett's esophagus with dysplasia as the original indication for ablative treatment.
  • Previous fundoplication surgery is permitted
  • Age 18 years to 98 years
  • Ability to provide written, informed consent

Exclusion Criteria:

  • Inability to obtain biopsies due to anticoagulation, varices, etc.
  • Previous ablation therapy, wide area mucosal resection or external beam radiation to the thorax.
  • Intolerance to twice daily proton pump inhibitor medication or inability to undergo sedation or endoscopic procedures.
  • Worse than Grade B erosive esophagitis
  • Less than 3 weeks from previous endoscopy with biopsy or 6 weeks from previous endoscopic therapy (resection).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477177

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Chek-Med Systems, Inc.
  More Information

No publications provided

Responsible Party: Herbert C. Wolfsen, Professor of Medicine, Division of Gastroenterology and Hepatology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01477177     History of Changes
Other Study ID Numbers: 11-004237
Study First Received: October 24, 2011
Last Updated: February 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Barrett's esophagus dysplasia

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

ClinicalTrials.gov processed this record on May 19, 2013