Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus

Not Applicable

Terminated

• Conditions: Barrett's Esophagus
• Interventions: Device: Polar Wand carbon dioxide cryotherapy

• Registration Number: NCT01477177
• Lead Sponsor: Mayo Clinic

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2019-04
• Results First Submitted: 2019-04-23
• Results First Submitted QC: 2019-04-23
• Last Update Submitted: 2019-04-23
• Results First Posted: 2019-05-15
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Polar Wand Treatment	Polar Wand carbon dioxide cryotherapy	Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia

Primary Outcome Measures

Name	Time	Method
Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification	12 months	The reduction of Barrett's segment length and histology classification will be measured at 12 months.

Secondary Outcome Measures

Name	Time	Method
Reduction in Barrett's Segment Length, Using the Prague Classification	6 and 12 months
Assessment of Complications	12 months	Specific complications are GI Bleeding and Perforation and Stricture and Ulceration
Assessment of Post-ablation Symptoms	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	6 months	The reduction of Barrett's segment length and histology classification will be measured at 6 months.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States