Barrett's Esophagus With Persistent Dysplasia orNCT01882478
Cryotherapy -BEATS-RF Ablation Trial
An observational study of Barrett's Esophagus With Persistent Dysplasia or and Early Esophageal Adenocarcinoma Post Radio Frequency Ablation, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine whether cryotherapy is effective in the treatment of persistent high grade dysplasia (HGD) or early esophageal adenocarcinoma (IMCA) in patients who have not responded to radiofrequency ablation (RFA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus With Persistent Dysplasia or, Early Esophageal Adenocarcinoma Post Radio Frequency Ablation
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with persistent BE with HGD or IMCA despite 2 or more serial RF ablation treatment sessions in a cohort of patients undergoing endoscopic therapy.
Who may be able to join
- Age > 18 years old
- Able to provide informed consent
- Patients with unifocal or multifocal BE with HGD or IMCA who have failed at least 2 serial RFA therapy.
- Patients who refused esophagectomy or deemed inoperable or whose BE dysplasia is not amenable to endoscopic mucosal resection (EMR) treatment alone due to: (1) extensive multifocal lesions (2) severe coagulopathy or any medical condition deemed high risk for EMR (3) patient refuses EMR
- Patients with a nodular BE lesions may undergo clinically-indicated EMR and still be eligible for enrollment as long as they have BE-HGD lesion/s that are still candidate for ablative treatment
Who cannot join
- Age younger than 18 years old
- Life expectancy less than 12 months
- Pregnancy
- Presence of esophageal varices
- Esophageal stricture precluding passage of an endoscope and suction tubing
- Any procedure that has impeded normal gastric emptying or limited gastric volume distention, including but not limited to gastric bypass, stomach stapling, gastrojejunostomy or any disease state has significantly reduced the elasticity in the GI tract (e.g. Marfan's syndrome, Scleroderma or any Connective Tissue Disease)
- Esophageal cancer (T2 and above)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CryoSpray Ablation for Barrett's Esophagus After Treatment Failure With Serial RadioFrequency Ablation
The purpose of this study is to determine whether cryotherapy is effective in the treatment of persistent high grade dysplasia (HGD) or early esophageal adenocarcinoma (IMCA) in patients who have not responded to radiofrequency ablation (RFA).
- Conditions
- Barrett's Esophagus With Persistent Dysplasia or, Early Esophageal Adenocarcinoma Post Radio Frequency Ablation
- Keywords
- Barrett's esophagus, Early esophageal adenocarcinoma, Radio Frequency Ablation, Cryotherapy
- 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.
| Study group | Role | What they receive |
|---|---|---|
| failure to respond to RF ablation | patients undergoing endoscopic RF ablation therapy with persistent BE with HGD or IMCA despite 2 or more serial RF ablation treatment sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
To assess efficacy of achieving elimination of dysplasia in patients with RFA-refractory BE with HGD or IMCA
Measured: 2 years
Secondary outcomes (1)
Predictors of response
To identify potential predictors of CE-D and CE-IM in patients requiring rescue CSA treatment after failed RFA therapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's Esophagus With Persistent Dysplasia orStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth K. Wang, Mayo Clinic
- Investigators
- Kenneth K Wang, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882478
- Sponsor's protocol ID
- 12-006030
- Status last verified
- Oct 2021
- First submitted
- 18 Jun 2013
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CryoSpray Ablation for Barrett's Esophagus After Treatment Failure With Serial RadioFrequency Ablation
- ClinicalTrials.gov ID
- NCT01882478
- Acronym / sponsor ID
- 12-006030
- Conditions
- Barrett's Esophagus With Persistent Dysplasia or, Early Esophageal Adenocarcinoma Post Radio Frequency Ablation
- Keywords
- Barrett's esophagus, Early esophageal adenocarcinoma, Radio Frequency Ablation, Cryotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 20 Jun 2013 (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 determine whether cryotherapy is effective in the treatment of persistent high grade dysplasia (HGD) or early esophageal adenocarcinoma (IMCA) in patients who have not responded to radiofrequency ablation (RFA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| failure to respond to RF ablation | – | –patients undergoing endoscopic RF ablation therapy with persistent BE with HGD or IMCA despite 2 or more serial RF ablation treatment sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with persistent BE with HGD or IMCA despite 2 or more serial RF ablation treatment sessions in a cohort of patients undergoing endoscopic therapy.
Key inclusion criteria (5 listed)
- Age > 18 years old
- Able to provide informed consent
- Patients with unifocal or multifocal BE with HGD or IMCA who have failed at least 2 serial RFA therapy.
- Patients who refused esophagectomy or deemed inoperable or whose BE dysplasia is not amenable to endoscopic mucosal resection (EMR) treatment alone due to: (1) extensive multifocal lesions (2) severe coagulopathy or any medical condition deemed high risk for EMR (3) patient refuses EMR
- Patients with a nodular BE lesions may undergo clinically-indicated EMR and still be eligible for enrollment as long as they have BE-HGD lesion/s that are still candidate for ablative treatment
Key exclusion criteria (7 listed)
- Age younger than 18 years old
- Life expectancy less than 12 months
- Pregnancy
- Presence of esophageal varices
- Esophageal stricture precluding passage of an endoscope and suction tubing
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
Response
Time frame: 2 years
To assess efficacy of achieving elimination of dysplasia in patients with RFA-refractory BE with HGD or IMCA
1 secondary outcome
Predictors of response
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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.
Kenneth K Wang, 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 With Persistent Dysplasia or and Early Esophageal Adenocarcinoma Post Radio Frequency Ablation, 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 5 inclusion and 7 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 20 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 2 years). 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 20 Oct 2021.