Cryotherapy -BEATS-RF Ablation Trial | NCT01882478

Studies
Cryotherapy -BEATS-RF Ablation Trial

NCT01882478

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Oct 20, 2021Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Barrett's Esophagus With Persistent Dysplasia or
Early Esophageal Adenocarcinoma Post Radio Frequency Ablation

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jun 2021Actual

Completion Date

Jun 2021Actual

First Submitted Date

Jun 18, 2013

First Submission Date that Met QC Criteria

Jun 18, 2013

First Posted Date

Jun 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2021

Last Update Posted Date

Oct 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether cryotherapy is effective in the treatment of persistent high grade dysplasia (HGD) or early esophageal adenocarcinoma (IMCA) in patients who have not responded to radiofrequency ablation (RFA).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Label	Type	Description	Intervention Names
failure to respond to RF ablation		patients undergoing endoscopic RF ablation therapy with persistent BE with HGD or IMCA despite 2 or more serial RF ablation treatment sessions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response	To assess efficacy of achieving elimination of dysplasia in patients with RFA-refractory BE with HGD or IMCA	2 years

Secondary Outcomes

Measure	Description	Time Frame
Predictors of response	To identify potential predictors of CE-D and CE-IM in patients requiring rescue CSA treatment after failed RFA therapy	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years old
Able to provide informed consent
Patients with unifocal or multifocal BE with HGD or IMCA who have failed at least 2 serial RFA therapy.
Patients who refused esophagectomy or deemed inoperable or whose BE dysplasia is not amenable to endoscopic mucosal resection (EMR) treatment alone due to: (1) extensive multifocal lesions (2) severe coagulopathy or any medical condition deemed high risk for EMR (3) patient refuses EMR
Patients with a nodular BE lesions may undergo clinically-indicated EMR and still be eligible for enrollment as long as they have BE-HGD lesion/s that are still candidate for ablative treatment

Exclusion Criteria:

Age younger than 18 years old
Life expectancy less than 12 months
Pregnancy
Presence of esophageal varices
Esophageal stricture precluding passage of an endoscope and suction tubing
Any procedure that has impeded normal gastric emptying or limited gastric volume distention, including but not limited to gastric bypass, stomach stapling, gastrojejunostomy or any disease state has significantly reduced the elasticity in the GI tract (e.g. Marfan's syndrome, Scleroderma or any Connective Tissue Disease)
Esophageal cancer (T2 and above)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with persistent BE with HGD or IMCA despite 2 or more serial RF ablation treatment sessions in a cohort of patients undergoing endoscopic therapy.

Sampling Method

Probability Sample

Name	Affiliation	Role
Kenneth K Wang, MD	Mayo Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

Condition Browse Module

MeSH Terms

ID	Term
D001471	Barrett Esophagus
C562730	Adenocarcinoma Of Esophagus

Ancestor Terms

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided