Barrett's EsophagusNCT02210039
Using Spectrally Encoded Confocal Microscopy (SECM) to Visualise the Esophagus Using an SECM Probe
A study testing SECM Probe in people with Barrett's Esophagus, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The study is being done to test the feasibility and tolerability of a SECM imaging probe in patients with Barrett's Esophagus (BE). Subjects will undergo SECM probe imaging while they are under conscious sedation. Spiral SECM imaging will be performed continuously over a pre-determined length. 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?
- SECM Probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 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
- A previous diagnosis of Barrett's Esophagus
- Patients must be over the age of 18
- Patient must be able to give informed consent
Who cannot join
- Subjects with any history of intestinal strictures
- OR subjects with a history of prior GI surgery
- OR subjects with a history of 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 to Image the Esophagus Using a SECM Probe
The study is being done to test the feasibility and tolerability of a SECM imaging probe in patients with Barrett's Esophagus (BE).
Subjects will undergo SECM probe imaging while they are under conscious sedation. Spiral SECM imaging will be performed continuously over a pre-determined length. Patients will later be asked for their feedback.
Read the detailed description
Subjects with a previous diagnosis of Barrett's Esophagus will be recruited in the study and undergo SECM probe imaging while using conscious sedation, pulse oximetry and blood pressure monitoring. The probe will be inserted the predetermined required distance in the esophagus using a guide wire.
Once the SECM imaging probe is in place, spiral SECM image data will be continuously collected over a pre-determined length (approximately 5cm).
- Conditions
- Barrett's Esophagus
- Being tested
- SECM Probe
- Keywords
- SECM, Esophagus, Imaging
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SECM ProbeDevice
Imaging of the esophagus using SECM probe and system.
| Study group | Role | What they receive |
|---|---|---|
| SECM Probe Imaging | Experimental | SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System. Receives: Device: SECM Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Tolerability of the Procedure
We were monitoring the number of participants able to tolerate the procedure. All six participating subjects have been asked for a feedback about tolerability of the procedure using a specific tolerability questionnaire.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionDec 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210039
- Sponsor's protocol ID
- 2013-P-001213
- Status last verified
- Apr 2019
- First submitted
- 4 Aug 2014
- Last updated
- 3 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 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Image the Esophagus Using a SECM Probe
- ClinicalTrials.gov ID
- NCT02210039
- Acronym / sponsor ID
- 2013-P-001213
- Conditions
- Barrett's Esophagus
- Keywords
- SECM, Esophagus, Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Aug 2014 (estimated)
- Results
- Posted 23 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being done to test the feasibility and tolerability of a SECM imaging probe in patients with Barrett's Esophagus (BE).
Subjects will undergo SECM probe imaging while they are under conscious sedation. Spiral SECM imaging will be performed continuously over a pre-determined length. Patients will later be asked for their feedback.
Detailed description
Subjects with a previous diagnosis of Barrett's Esophagus will be recruited in the study and undergo SECM probe imaging while using conscious sedation, pulse oximetry and blood pressure monitoring. The probe will be inserted the predetermined required distance in the esophagus using a guide wire.
Once the SECM imaging probe is in place, spiral SECM image data will be continuously collected over a pre-determined length (approximately 5cm).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SECM Probe Imaging | Experimental | Device: SECM ProbeSECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A previous diagnosis of Barrett's Esophagus
- Patients must be over the age of 18
- Patient must be able to give informed consent
Key exclusion criteria (3 listed)
- Subjects with any history of intestinal strictures
- OR subjects with a history of prior GI surgery
- OR subjects with a history of 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 |
|---|---|---|
| SECM ProbeImaging of the esophagus using SECM probe and system. | Device | SECM Probe Imaging |
Primary outcome
Number of Participants With Tolerability of the Procedure
Time frame: During the procedure
We were monitoring the number of participants able to tolerate the procedure. All six participating subjects have been asked for a feedback about tolerability of the procedure using a specific tolerability questionnaire.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Barrett Esophagus
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 SECM Probe 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 3 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: finished, as of the sponsor's last update on 3 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 Oct 2018). 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?
Number of Participants With Tolerability of the Procedure (time frame: During the procedure). 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 3 Apr 2019.