Cryoballoon: Cryo Balloon for Residual Barrett's Esophagus

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02230410
• Collaborator: Pentax Medical (Industry)
• Enrollment: 18
• Location: 1
• Arm: 1
• Duration (Months): 33.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Barrett's Esophagus	Device: CryoBalloon Focal Ablation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CryoBalloon Focal Ablation System for Residual Barretts Esophagus Post Ablation; a Pilot Study.
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: May 26, 2017
• Actual Study Completion Date: May 26, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: focal cryo ablation Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment	Device: CryoBalloon Focal Ablation

Outcome Measures

Primary Outcome Measures

1. Eradication of Barrett's Esophagus [3 months post Cryoballon Focal Ablation]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• 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,

Exclusion criteria:

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• Pentax Medical

Investigators

• Principal Investigator: Kenneth Wang, MD, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol - Apr 4, 2016

More Information

Additional Information:

• research lab web site related information
• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Kenneth K. Wang, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02230410
• Other Study ID Numbers: 14-004771
• First Posted: Sep 3, 2014
• Last Update Posted: Feb 10, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Kenneth K. Wang, Principal Investigator, Mayo Clinic: Barrett's; high grade dysplasia; ablation; cyrotherapy
• Additional relevant MeSH terms: Barrett Esophagus

Study Results

Participant Flow

Arm/Group Title	Focal Cryo Ablation
Arm/Group Description	Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment CryoBalloon Focal Ablation
Period Title: Overall Study
STARTED	18
COMPLETED	15
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Focal Cryo Ablation
Arm/Group Description	Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment CryoBalloon Focal Ablation
Overall Participants	18
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.94 (7.99)
Sex: Female, Male (Count of Participants)
Female	2 11.1%
Male	16 88.9%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	18 100%

Outcome Measures

1. Primary Outcome

Title	Eradication of Barrett's Esophagus
Description	Number of subjects to have eradication of barrett's esophagus after Cryoballoon Focal Ablation
Time Frame	3 months post Cryoballon Focal Ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Focal Cryo Ablation
Arm/Group Description	Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment CryoBalloon Focal Ablation
Measure Participants	15
Count of Participants [Participants]	2 11.1%

Adverse Events

Time Frame	Adverse events were collected from baseline to end of study for a total of approximately 3 months on all participants.
Arm/Group Title	Focal Cryo Ablation
Arm/Group Description	Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment CryoBalloon Focal Ablation
All Cause Mortality
	Focal Cryo Ablation
	Affected / at Risk (%)	# Events
Total	1/18 (5.6%)
Serious Adverse Events
	Focal Cryo Ablation
	Affected / at Risk (%)	# Events
Total	0/18 (0%)
Other (Not Including Serious) Adverse Events
	Focal Cryo Ablation
	Affected / at Risk (%)	# Events
Total	1/18 (5.6%)
Gastrointestinal disorders
Difficulty Swallowing	1/18 (5.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.