Barrett's EsophagusOFDINCT01439594
Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation
A study testing MGH OFDI Imaging in people with Barrett's Esophagus, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this research is to conduct a pilot clinical study to evaluate the potential use of esophageal Optical Frequency Domain Imaging (OFDI) for assessing the success and degree of injury associated with therapeutic radiofrequency ablation techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- MGH OFDI Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of Barrett's esophagus
- Patients undergoing an Esophagogastroduodenoscopy (EGD)
- Patients scheduled for treatment with RF ablation or patients that have had previous BARRX RF ablation
- Patients must be over the age of 18
- Patient must be able to give informed consent
- Women with child bearing potential must have a negative pregnancy test prior to procedure
Who cannot join
- Patients on oral anticoagulation medications
- Patients with a history of hemostasis disorders
- Patients that are pregnant
- Patients with esophageal strictures
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing the Tissue Response to Radiofrequency Ablation
The goal of this research is to conduct a pilot clinical study to evaluate the potential use of esophageal Optical Frequency Domain Imaging (OFDI) for assessing the success and degree of injury associated with therapeutic radiofrequency ablation techniques.
Read the detailed description
This is a single center pilot study conducted in 30 patients scheduled for therapeutic intervention. As the purpose of the study is to assess the response of the esophagus to radio frequency (RF) ablation, and the degree of residual Barrett's Esophagus (BE) remaining following treatment, OFDI imaging of study participants will occur prior to the scheduled BARRX RF treatment, and at the standard 3 and 6 month follow-up visits.
Following initial visual surveillance of the esophagus, the study experimental procedure will begin. Imaging will be performed with the OFDI system in 4 longitudinal (~5cm) volumetric segments that are spaced equally circumferentially along the esophagus in a similar fashion to the standard 4-quadrant biopsy protocol.
Each of the 4 OFDI imaging segments will be acquired in less than 1 minute.
- Conditions
- Barrett's Esophagus
- Being tested
- MGH OFDI Imaging
- Keywords
- Barrett's Esophagus, Esophagus, OCT, Imaging, Radiofrequency Ablation, BARRX
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGH OFDI ImagingDevice
Imaging of Esophagus with OFDI system
| Study group | Role | What they receive |
|---|---|---|
| MGH OFDI Imaging | Experimental | OFDI imaging Receives: Device: MGH OFDI Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions
Images will be taken and compared to standard of care biopsy to assess the success and degree of injury associated with radiofrequency ablation techniques. A successful imaging session is defined as any session where the OFDI device was able to take and produce discernible and clear data that is comparable to corresponding biopsy histopathology. It is considered unsuccessful if we were unable to produce OFDI data and/or attain a corresponding biopsy.
Measured: During the OFDI imaging session (about 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startOct 2008
- Primary completionMar 2014
- Study completionMar 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.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Tearney, Massachusetts General Hospital
- Investigators
- Guillermo Tearney, MD PhD, Principal investigator, Massachusetts General HospitalNorman Nishioka, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439594
- Sponsor's protocol ID
- 2008-P000793
- Acronym
- OFDI
- Status last verified
- Nov 2019
- First submitted
- 20 Sep 2011
- Last updated
- 22 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing the Tissue Response to Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT01439594
- Acronym / sponsor ID
- OFDI / 2008-P000793
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's Esophagus, Esophagus, OCT, Imaging, Radiofrequency Ablation, BARRX
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Oct 2008 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 23 Sep 2011 (estimated)
- Results
- Posted 22 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research is to conduct a pilot clinical study to evaluate the potential use of esophageal Optical Frequency Domain Imaging (OFDI) for assessing the success and degree of injury associated with therapeutic radiofrequency ablation techniques.
Detailed description
This is a single center pilot study conducted in 30 patients scheduled for therapeutic intervention. As the purpose of the study is to assess the response of the esophagus to radio frequency (RF) ablation, and the degree of residual Barrett's Esophagus (BE) remaining following treatment, OFDI imaging of study participants will occur prior to the scheduled BARRX RF treatment, and at the standard 3 and 6 month follow-up visits.
Following initial visual surveillance of the esophagus, the study experimental procedure will begin. Imaging will be performed with the OFDI system in 4 longitudinal (~5cm) volumetric segments that are spaced equally circumferentially along the esophagus in a similar fashion to the standard 4-quadrant biopsy protocol.
Each of the 4 OFDI imaging segments will be acquired in less than 1 minute.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MGH OFDI Imaging | Experimental | Device: MGH OFDI ImagingOFDI imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a diagnosis of Barrett's esophagus
- Patients undergoing an Esophagogastroduodenoscopy (EGD)
- Patients scheduled for treatment with RF ablation or patients that have had previous BARRX RF ablation
- Patients must be over the age of 18
- Patient must be able to give informed consent
Key exclusion criteria (4 listed)
- Patients on oral anticoagulation medications
- Patients with a history of hemostasis disorders
- Patients that are pregnant
- Patients with esophageal strictures
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 |
|---|---|---|
| MGH OFDI ImagingImaging of Esophagus with OFDI system | Device | MGH OFDI Imaging |
Primary outcome
Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions
Time frame: During the OFDI imaging session (about 5 minutes)
Images will be taken and compared to standard of care biopsy to assess the success and degree of injury associated with radiofrequency ablation techniques. A successful imaging session is defined as any session where the OFDI device was able to take and produce discernible and clear data that is comparable to corresponding biopsy histopathology. It is considered unsuccessful if we were unable to produce OFDI data and/or attain a corresponding biopsy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Guillermo Tearney, MD PhD principal investigator
Massachusetts General Hospital
Norman Nishioka, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MGH OFDI Imaging in people with Barrett's Esophagus, run by Massachusetts General Hospital 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 6 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 22 Nov 2019. 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 22 Nov 2019). 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?
Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions (time frame: During the OFDI imaging session (about 5 minutes)). 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 22 Nov 2019.