Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01477177
Recruitment Status : Terminated (enrollment much slower than anticipated, and, funding issues)
First Posted : November 22, 2011
Results First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
Chek-Med Systems, Inc.
Information provided by (Responsible Party):
Herbert C. Wolfsen, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE October 24, 2011
First Posted Date  ICMJE November 22, 2011
Results First Submitted Date  ICMJE April 23, 2019
Results First Posted Date  ICMJE May 15, 2019
Last Update Posted Date May 15, 2019
Study Start Date  ICMJE August 2011
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2011)
Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification [ Time Frame: 12 months ]
The reduction of Barrett's segment length and histology classification will be measured at 12 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01477177 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2013)
  • Reduction in Barrett's Segment Length, Using the Prague Classification [ Time Frame: 6 and 12 months ]
  • Assessment of Complications [ Time Frame: 12 months ]
    Specific complications are GI Bleeding and Perforation and Stricture and Ulceration
  • Assessment of Post-ablation Symptoms [ Time Frame: 12 months ]
    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 ]
    The reduction of Barrett's segment length and histology classification will be measured at 6 months.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2011)
  • Reduction in Barrett's segment length, using the Prague clasification [ Time Frame: 6 and 12 months ]
  • Assessment of Complications [ Time Frame: 12 months ]
    Specific complications are GI Bleeding and Perforation and Stricture and Ulceration
  • Assessment of Post-ablation Symptoms [ Time Frame: 12 months ]
    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 ]
    The reduction of Barrett's segment length and histology classification will be measured at 6 months.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus
Official Title  ICMJE Pilot Study of Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus With Low Grade and High Grade Dysplasia
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Barrett's Esophagus
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Polar Wand Treatment
Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia
Intervention: Device: Polar Wand carbon dioxide cryotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 8, 2014)
4
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2011)
14
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 98 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01477177
Other Study ID Numbers  ICMJE 11-004237
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Herbert C. Wolfsen, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Chek-Med Systems, Inc.
Investigators  ICMJE Not Provided
PRS Account Mayo Clinic
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP