Barrett's EsophagusHALONCT02033070
Patient Registry: Radio Frequency Ablation of Barrett's Esophagus Using HALO System
An observational study of Barrett's Esophagus, run by Ochsner Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Barrett's Esophagus
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Nov 2015
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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
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)
Who may be able to join
- 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
Who cannot join
- has not been diagnosed with Barrett's Esophagus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Center Patient Registry Using Radio Frequency Ablation of Barrett's Esophagus Using HALO System
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.
- Conditions
- Barrett's Esophagus
- Keywords
- RFA
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-Dysplastic IM, LGD, HGD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic clearance rate for Barrett's Esophagus
Measured: Outcome measure is assessed at Month 12
Secondary outcomes (1)
Histological clearance rate for intestinal metaplasia
Measured: Biopsy taken at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virendra Joshi, Ochsner Health System
- Investigators
- Virendra Joshi, MD, Principal investigator, Oshsner Clinic Foundation and Medical Center-Kenner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033070
- Sponsor's protocol ID
- Barrett's RFA
- Acronym
- HALO
- Status last verified
- Jan 2014
- First submitted
- 8 Jan 2014
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Patient Registry Using Radio Frequency Ablation of Barrett's Esophagus Using HALO System
- ClinicalTrials.gov ID
- NCT02033070
- Acronym / sponsor ID
- HALO / Barrett's RFA
- Conditions
- Barrett's Esophagus
- Keywords
- RFA
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2015 (estimated)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Dysplastic IM, LGD, HGD | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- has not been diagnosed with Barrett's Esophagus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Endoscopic clearance rate for Barrett's Esophagus
Time frame: Outcome measure is assessed at Month 12
1 secondary outcome
Histological clearance rate for intestinal metaplasia
Time frame: Biopsy taken at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
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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.
Virendra Joshi, MD principal investigator
Oshsner Clinic Foundation and Medical Center-Kenner
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett's Esophagus, run by Ochsner Health System 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Jan 2014. 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?
Results are not available in the source record.
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 (time frame: Outcome measure is assessed at Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2014.