Ignite Creation Date:
2024-05-05 @ 9:14 PM
Last Modification Date:
2024-10-26 @ 10:01 AM
Study NCT ID:
NCT00848237
Status:
COMPLETED
Last Update Posted:
2016-02-05
First Post:
2007-12-20
Brief Title:
HALO Patient Registry Ablation of Barretts Esophagus
Sponsor:
Medtronic - MITG
Organization:
Medtronic - MITG
Study Overview
Official Title:
HALO Patient Registry Ablation of Barretts Esophagus A Multi-Center Patient Registry
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The HALO Patient Registry is a prospectiveretrospective multi-center patient registry It provides a framework for treatment and follow-up of patients with Barretts esophagus non-dysplastic IM LGD and HGD The primary objective is to provide a tool for participating physician investigators to collect outcomes data related to the use of the HALO Ablation Systems
Detailed Description:
Summary The HALO Patient Registry provides a framework for treatment and follow-up of patients with Barretts esophagus non-dysplastic IM LGD and HGD The primary objective is to provide a tool for participating physician investigators to collect outcomes data related to the use of the HALO Ablation Systems
Protocol Design
This is a prospective multi-center patient Registry Sites may choose to also retrospectively enroll previously treated patients after obtaining informed consent and enter retrospective data into case report forms on-line Retrospective data collection is defined as any data other than patient history collected prior to signing of the informed consent A set of case report forms CRFs is provided along with this protocol to track outcomes The CRFs may be completed and retained on site but the site is recommended to utilize the internet-based data entry system
Protocol Design
This is a prospective multi-center patient Registry Sites may choose to also retrospectively enroll previously treated patients after obtaining informed consent and enter retrospective data into case report forms on-line Retrospective data collection is defined as any data other than patient history collected prior to signing of the informed consent A set of case report forms CRFs is provided along with this protocol to track outcomes The CRFs may be completed and retained on site but the site is recommended to utilize the internet-based data entry system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None