Barrett's Esophagusablation IN BENCT00587314
The Effect of Ablation Therapy on Barrett's Esophagus
An observational study of Barrett's Esophagus and Early Esophageal Adenocarcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
To assess the effect of ablative therapy (Photodynamic Therapy or Radiofrequency ablation ) on Barrett's Esophagus Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Barrett's Esophagus, Early Esophageal Adenocarcinoma
- What is being tested?
- Biopsy
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have had or qualify for ablation therapy for treatment of their barrett's esophagus
Who may be able to join
- Patients who have had or qualify for ablation therapy for treatment of their barrett's esophagus with high grade dysplasia or early esophageal adenocarcinoma
- Ability to provide informed consent
Who cannot join
- Eastern Cooperative Oncology Group performance status 3 or 4
- Inability to tolerate endoscopic procedures
- Pregnancy: Females of child-bearing age will be screened with pregnancy test.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
To assess the effect of ablative therapy (Photodynamic Therapy or Radiofrequency ablation ) on Barrett's Esophagus
Read the detailed description
To assess the effect of ablation therapy on Barrett's esophagus. Proposal Ablation therapy is an FDA approved treatment to decrease cancer risk in Barrett's esophagus mucosa. This is being performed in our Barrett's Esophagus Unit on a regular basis. However, the longterm outcomes of this therapy is not established and there are patients who have been treated who later re-develop Barrett's mucosa. This study will allow us store tissue samples that can later be used to assess the effect of ablative therapy on Barrett's esophagus.
- Being tested
- Biopsy
- Keywords
- Photodynamic Therapy, Barrett's Esophagus, Early Esophageal Adenocarcinoma
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyOther
Biopsies for research purposes will be obtained when returning for clinically indicated surveillance of Barrett's Esophagus
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with Barrett's Esophagus or early esophageal adenocarcinoma who will or have had ablation therapy will be enrolled in this long term follow up study Receives: Other: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment
presence of persistent or recurrence of barrett's esophagus and/or dysplasia
Measured: at time of surveillance intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startJan 2004
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (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.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cadman Leggett, Mayo Clinic
- Investigators
- Cadman Leggett, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587314
- Sponsor's protocol ID
- 258-04
- Acronym
- ablation IN BE
- Status last verified
- Mar 2026
- First submitted
- 21 Dec 2007
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ablation Therapy on Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT00587314
- Acronym / sponsor ID
- ablation IN BE / 258-04
- Keywords
- Photodynamic Therapy, Barrett's Esophagus, Early Esophageal Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 7 Jan 2008 (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.
To assess the effect of ablative therapy (Photodynamic Therapy or Radiofrequency ablation ) on Barrett's Esophagus
Detailed description
To assess the effect of ablation therapy on Barrett's esophagus. Proposal Ablation therapy is an FDA approved treatment to decrease cancer risk in Barrett's esophagus mucosa. This is being performed in our Barrett's Esophagus Unit on a regular basis. However, the longterm outcomes of this therapy is not established and there are patients who have been treated who later re-develop Barrett's mucosa. This study will allow us store tissue samples that can later be used to assess the effect of ablative therapy on Barrett's esophagus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: BiopsyPatients with Barrett's Esophagus or early esophageal adenocarcinoma who will or have had ablation therapy will be enrolled in this long term follow up study |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have had or qualify for ablation therapy for treatment of their barrett's esophagus
Key inclusion criteria (2 listed)
- Patients who have had or qualify for ablation therapy for treatment of their barrett's esophagus with high grade dysplasia or early esophageal adenocarcinoma
- Ability to provide informed consent
Key exclusion criteria (3 listed)
- Eastern Cooperative Oncology Group performance status 3 or 4
- Inability to tolerate endoscopic procedures
- Pregnancy: Females of child-bearing age will be screened with pregnancy test.
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 |
|---|---|---|
| BiopsyBiopsies for research purposes will be obtained when returning for clinically indicated surveillance of Barrett's Esophagus | Other | 1 |
Primary outcome
Response to treatment
Time frame: at time of surveillance intervals
presence of persistent or recurrence of barrett's esophagus and/or dysplasia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
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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.
Cadman Leggett, MD principal investigator
Mayo Clinic
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 and Early Esophageal Adenocarcinoma, run by Mayo Clinic 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 3 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: enrolling by invitation, as of the sponsor's last update on 11 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Response to treatment (time frame: at time of surveillance intervals). 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 11 Mar 2026.