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
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