Cryo Balloon for Residual Barrett's Esophagus

NCT02230410 | Completed Results FDA Device

• 1 other identifier: 14-004771
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to see if treating residual Barrett's Esophagus after previously having undergone Radiofrequency ablation or Endoscopic Mucosal resection can be eliminated with focal cryotherapy.

Conditions

Barrett's Esophagus

Keywords

Barrett's; high grade dysplasia; ablation; cyrotherapy

Outcome Measures

Primary Outcomes (1)

• Eradication of Barrett's Esophagus

  Number of subjects to have eradication of barrett's esophagus after Cryoballoon Focal Ablation

  3 months post Cryoballon Focal Ablation

Study Arms (1)

focal cryo ablation

EXPERIMENTAL

Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment

Device: CryoBalloon Focal Ablation

Interventions

CryoBalloon Focal Ablation DEVICE

focal cryo ablation

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years old
• Able to provide informed consent
• 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,

You may not qualify if:

• Age younger than 18 years old
• Presence of esophageal varices
• Esophageal stricture precluding passage of an endoscope
• Inability to provide informed consent
• Esophageal cancer (T2 and above)
• Coagulopathy with INR \> 2.0, thrombocytopenia with platelet counts \< 50,000
• Pregnancy (if required a pregnancy test would be performed as part of routine clinical care)

Sponsors & Collaborators

• Mayo Clinic: lead
• Pentax Medical: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, 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: Dr. Kenneth K. Wang
• Organization: Mayo Clinic

wang.kenneth@mayo.edu

507-293-7911

Study Officials

• Kenneth Wang, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: September 3, 2014
• Study Start: August 1, 2014
• Primary Completion: May 26, 2017
• Study Completion: May 26, 2017
• Last Updated: February 10, 2022
• Results First Posted: February 10, 2022

Record last verified: 2022-01

Locations

US (1)