Barrett's EsophagusNCT02204150
Study to Image the Esophagus Using the OFDI Capsule
A study testing OFDI Capsule in people with Barrett's Esophagus and Eosinophilic Esophagitis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI) Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Barrett's Esophagus, Eosinophilic Esophagitis
- What is being tested?
- OFDI Capsule
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jul 2016
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A previous diagnosis of Barrett's Esophagus
- OR a previous diagnosis of EoE
- OR a previous diagnosis of Gastroesophageal reflux disease (GERD)
- Subject must be 18 years or older in case of Barrett's and GERD, and over the age of 16 years for EoE
- Subject must be able to give informed consent
Who cannot join
- Subjects with known esophageal strictures, intestinal strictures or dysphagia
- OR subjects with a history of prior GI surgery or GI Intestinal Crohn's disease
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 for Imaging of the Esophagus Using an OFDI Capsule
The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)
Read the detailed description
A total of 56 subjects with Barrett's Esophagus, EoE and healthy volunteers will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.
As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.
- Conditions
- Barrett's Esophagus, Eosinophilic Esophagitis
- Being tested
- OFDI Capsule
- Keywords
- Optical Coherence Tomography, Barrett's Esophagus, Esophagus, Imaging
- Medical subject headings
- Barrett Esophagus, Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OFDI CapsuleDevice
Imaging of the esophagus using the OFDI Capsule and system
| Study group | Role | What they receive |
|---|---|---|
| OFDI Capsule Imaging | Experimental | Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system. Receives: Device: OFDI Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule
Number of subjects from whom the quality OFDI imaging was obtained
Measured: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startFeb 2012
- Primary completion31 Jul 2015
- Study completionJul 2016
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Guillermo Tearney, Massachusetts General Hospital
- Investigators
- Guillermo Tearney, MD., PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204150
- Sponsor's protocol ID
- 2011P002619
- Other IDs
- 5R01CA103769-07
- Status last verified
- Apr 2019
- First submitted
- 12 Jun 2014
- Last updated
- 30 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Imaging of the Esophagus Using an OFDI Capsule
- ClinicalTrials.gov ID
- NCT02204150
- Acronym / sponsor ID
- 2011P002619
- Conditions
- Barrett's Esophagus, Eosinophilic Esophagitis
- Keywords
- Optical Coherence Tomography, Barrett's Esophagus, Esophagus, Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Feb 2012 (actual)
- Primary completion
- 31 Jul 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Posted 23 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)
Detailed description
A total of 56 subjects with Barrett's Esophagus, EoE and healthy volunteers will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.
As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OFDI Capsule Imaging | Experimental | Device: OFDI CapsuleSubject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- A previous diagnosis of Barrett's Esophagus
- OR a previous diagnosis of EoE
- OR a previous diagnosis of Gastroesophageal reflux disease (GERD)
- Subject must be 18 years or older in case of Barrett's and GERD, and over the age of 16 years for EoE
- Subject must be able to give informed consent
Key exclusion criteria (2 listed)
- Subjects with known esophageal strictures, intestinal strictures or dysphagia
- OR subjects with a history of prior GI surgery or GI Intestinal Crohn's disease
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 |
|---|---|---|
| OFDI CapsuleImaging of the esophagus using the OFDI Capsule and system | Device | OFDI Capsule Imaging |
Primary outcome
Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule
Time frame: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes
Number of subjects from whom the quality OFDI imaging was obtained
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OFDI Capsule in people with Barrett's Esophagus and Eosinophilic Esophagitis, 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 5 inclusion and 2 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 30 Apr 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 23 Apr 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 in Subjects Swallowing the OFDI Capsule (time frame: Images will be acquired during the OFDI imaging session which should take an average of 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 30 Apr 2019.