Barrett EsophagusNCT00848237
HALO Patient Registry: Ablation of Barrett's Esophagus
A study testing Radiofrequency Ablation (HALO Ablation Systems) in people with Barrett Esophagus, run by Medtronic - MITG at 1 site in United States.
Trial summary
The HALO Patient Registry is a prospective/retrospective, multi-center patient registry. It provides a framework for treatment and follow-up of patients with Barrett's esophagus (non-dysplastic IM, LGD and HGD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- Radiofrequency Ablation (HALO Ablation Systems)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,521 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must be a candidate for ablation of Barrett's esophagus with the HALO Ablation System.
- Must agree to the proposed follow-up schedule and provide informed consent for participation.
Who cannot join
- Pregnancy
- Prior radiation therapy to the esophagus
- Esophageal varices at risk for bleeding
- Prior Heller Myotomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Gastrointestinal Associates and sites across the US
Knoxville and Other US Cities, California, 27599-7080
About this study
Official title: HALO Patient Registry: Ablation of Barrett's Esophagus, A Multi-Center Patient Registry
The HALO Patient Registry is a prospective/retrospective, multi-center patient registry. It provides a framework for treatment and follow-up of patients with Barrett's 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.
Read the detailed description
Summary The HALO Patient Registry provides a framework for treatment and follow-up of patients with Barrett's 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.
- Conditions
- Barrett Esophagus
- Being tested
- Radiofrequency Ablation (HALO Ablation Systems)
- Keywords
- Barrett's Esophagus, Dysplasia, Intestinal Metaplasia
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency Ablation (HALO Ablation Systems)Device
Also called HALO 90, HALO 360
Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system. Receives: Device: Radiofrequency Ablation (HALO Ablation Systems) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up
% of patients with 100 % resolution at 1 year follow-up. This endpoint is a visual and not reliable or accurate. A better measure of clearance of Barrett's esophagus is based on biopsies.
Measured: 1 year
Histological Clearance Rate for Intestinal Metaplasia (CE-IM)
Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up
Measured: 1 year
Histological Clearance Rate for Dysplasia (CE-D)
percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up
Measured: 1 year
Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up
Percentage of patients at 1 year follow-up with sub-squamous intestinal metaplasia, with or without dysplasia, that is covered completely by an intact layer of squamous epithelium with no communication with the surface
Measured: 1 year
Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month
Patient who completed both baseline and follow-up Quality of Life: Scores (0-10) of quality of life at baseline and 12 month follow-up were measured and changes were calculated ( 12 months minus baseline) in: concerns about the condition of esophagus, negative impact on life and esophageal cancer worry. Scale range is 0-10, 0 is min and 10 is max. Higher value represent worse outcome (such as higher concern about the condition of esophagus, negative impact on life and higher esophageal cancer worry).
Measured: 12 month
Adverse Event Incidence
Adverse and Serious Adverse event with Definite device relationship
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startJul 2007
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,521 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas J Shaheen, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848237
- Sponsor's protocol ID
- B-500
- Status last verified
- Jan 2016
- First submitted
- 20 Dec 2007
- Last updated
- 5 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Shaheen NJ, Kim HP, Bulsiewicz WJ, Lyday WD, Triadafilopoulos G, Wolfsen HC, Komanduri S, Chmielewski GW, Ertan A, Corbett FS, Camara DS, Rothstein RI, Overholt BF. Prior fundoplication does not improve safety or efficacy outcomes of radiofrequency ablation: results from the U.S. RFA Registry. J Gastrointest Surg. 2013 Jan;17(1):21-8; discussion p.28-9. doi: 10.1007/s11605-012-2001-8. Epub 2012 Sep 11.
PubMed 22965650
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HALO Patient Registry: Ablation of Barrett's Esophagus, A Multi-Center Patient Registry
- ClinicalTrials.gov ID
- NCT00848237
- Acronym / sponsor ID
- B-500
- Conditions
- Barrett Esophagus
- Keywords
- Barrett's Esophagus, Dysplasia, Intestinal Metaplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,521 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Feb 2009 (estimated)
- Results
- Posted 5 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The HALO Patient Registry is a prospective/retrospective, multi-center patient registry. It provides a framework for treatment and follow-up of patients with Barrett's 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 Barrett's 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Radiofrequency Ablation (HALO Ablation Systems)All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Must be a candidate for ablation of Barrett's esophagus with the HALO Ablation System.
- Must agree to the proposed follow-up schedule and provide informed consent for participation.
Key exclusion criteria (4 listed)
- Pregnancy
- Prior radiation therapy to the esophagus
- Esophageal varices at risk for bleeding
- Prior Heller Myotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency Ablation (HALO Ablation Systems)Also: HALO 90, HALO 360Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy. | Device | Treatment |
Primary outcome
Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up
Time frame: 1 year
% of patients with 100 % resolution at 1 year follow-up. This endpoint is a visual and not reliable or accurate. A better measure of clearance of Barrett's esophagus is based on biopsies.
Histological Clearance Rate for Intestinal Metaplasia (CE-IM)
Time frame: 1 year
Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up
Histological Clearance Rate for Dysplasia (CE-D)
Time frame: 1 year
percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up
Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up
Time frame: 1 year
Percentage of patients at 1 year follow-up with sub-squamous intestinal metaplasia, with or without dysplasia, that is covered completely by an intact layer of squamous epithelium with no communication with the surface
Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month
Time frame: 12 month
Patient who completed both baseline and follow-up Quality of Life: Scores (0-10) of quality of life at baseline and 12 month follow-up were measured and changes were calculated ( 12 months minus baseline) in: concerns about the condition of esophagus, negative impact on life and esophageal cancer worry. Scale range is 0-10, 0 is min and 10 is max. Higher value represent worse outcome (such as higher concern about the condition of esophagus, negative impact on life and higher esophageal cancer worry).
Adverse Event Incidence
Time frame: 12 month
Adverse and Serious Adverse event with Definite device relationship
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22965650Shaheen NJ, Kim HP, Bulsiewicz WJ, Lyday WD, Triadafilopoulos G, Wolfsen HC, Komanduri S, Chmielewski GW, Ertan A, Corbett FS, Camara DS, Rothstein RI, Overholt BF. Prior fundoplication does not improve safety or efficacy outcomes of radiofrequency ablation: results from the U.S. RFA Registry. J Gastrointest Surg. 2013 Jan;17(1):21-8; discussion p.28-9. doi: 10.1007/s11605-012-2001-8. Epub 2012 Sep 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas J Shaheen, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Ablation (HALO Ablation Systems) in people with Barrett Esophagus, run by Medtronic - MITG at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00848237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2016.