Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus

NCT01477177 | Terminated Results

• 1 other identifier: 11-004237
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Barrett's Esophagus

Keywords

Barrett's esophagus dysplasia

Outcome Measures

Primary Outcomes (1)

• Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification

  The reduction of Barrett's segment length and histology classification will be measured at 12 months.

  12 months

Secondary Outcomes (4)

• Reduction in Barrett's Segment Length, Using the Prague Classification

  6 and 12 months

• Assessment of Complications

  12 months

• Assessment of Post-ablation Symptoms

  12 months

• Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification

  6 months

Study Arms (1)

Polar Wand Treatment

EXPERIMENTAL

Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia

Device: Polar Wand carbon dioxide cryotherapy

Interventions

Polar Wand carbon dioxide cryotherapy DEVICE

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.

Polar Wand Treatment

Eligibility Criteria

• Age: 18 Years - 98 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead
• Chek-Med Systems, Inc.: collaborator

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Herbert C. Wolfsen, M.D.
• Organization: Mayo Clinic

Wolfsen.Herbert@mayo.edu

904-953-6319

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Mayo College of Medicine

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: November 22, 2011
• Study Start: August 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 15, 2019
• Results First Posted: May 15, 2019

Record last verified: 2019-04

Locations

US (1)