Patient Registry: Radio Frequency Ablation of Barrett's E... | NCT02033070

Studies
Patient Registry: Radio Frequency Ablation of Barrett's Esophagus Using HALO System

NCT02033070

Sponsor

Ochsner Health System

Status

Unknown status

Last Update Posted

Jan 10, 2014Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Barrett's Esophagus

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

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Nov 2015Estimated

Completion Date

Not provided

First Submitted Date

Jan 8, 2014

First Submission Date that Met QC Criteria

Jan 9, 2014

First Posted Date

Jan 10, 2014Estimated

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

Jan 9, 2014

Last Update Posted Date

Jan 10, 2014Estimated

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 provide a tool for physicians to compare outcome data related to the use of the HALO Ablation Systems. This study is a single-center patient registry which will contribute to a framework for treatment and follow-up of patients with Barrett's Esophagus.

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

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

Not provided

Label	Type	Description	Intervention Names
Non-Dysplastic IM, LGD, HGD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Endoscopic clearance rate for Barrett's Esophagus		Outcome measure is assessed at Month 12

Secondary Outcomes

Measure	Description	Time Frame
Histological clearance rate for intestinal metaplasia		Biopsy taken at 12 months

Other Outcomes

Measure	Description	Time Frame
Histological clearance rate for dysplasia		Biopsy taken at 12 months to determine effectiveness

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

candidate for ablation of Barrett's Esophagus with the HALO Ablation System (Prospective)
received an ablation with the HALO Ablation System to treat Barrett's Esophagus (Retrospective)
candidate agrees to proposed follow-up schedule of yearly surveillance following treatment
signs consent

Exclusion Criteria:

has not been diagnosed with Barrett's Esophagus

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Adult patients presenting with esophageal intestinal metaplasia (IM), including the pathological subclasses of non-dysplastic IM, low-grade dysplasia (LGD) and high-grade dysplasia (HGD)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Virendra Joshi, MD	Oshsner Clinic Foundation and Medical Center-Kenner	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ochsner Medical Center		Kenner	Louisiana		United States

Condition Browse Module

MeSH Terms

ID	Term
D001471	Barrett Esophagus

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided