Barrett EsophagusNCT04561791
Evaluation of Tethered Capsule Endomicroscopy as a Screening Tool for Barrett's Esophagus in the Primary Care Setting
A study testing Tethered Capsule Endomicroscopy in people with Barrett Esophagus and Barrett's Esophagus Without Dysplasia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators will conduct a large study in the primary care clinic to determine the feasibility of using tethered capsule endomicroscopy as a screening method for Barrett's esophagus (BE) in the primary care practice environment. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Barrett Esophagus, Barrett's Esophagus Without Dysplasia, Barretts Esophagus With Dysplasia
- What is being tested?
- Tethered Capsule Endomicroscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2019to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants registered as patients at the Assembly Row primary care practice, MGH Broadway Primary Care - Revere, or Pentucket Medical Associates
- 18 years or older
- Able to give informed consent
- Participants must have no food for 1 hour before the procedure
Who cannot join
- Participants older than 75 years.
- Participants with current symptoms of dysphagia
- Participants with gastro-intestinal strictures with a diameter less than 8mm, prior GI surgery (Esophageal and/or stomach surgeries), or history of intestinal Crohn's disease
- Pregnancy
- Participants scheduled for an urgent care visit for the following symptoms: fever, sore throat, upper respiratory infection symptoms, nausea, vomiting, diarrhea, abdominal pain, or other symptoms as per clinical staff discretion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The investigators will conduct a large study in the primary care clinic to determine the feasibility of using tethered capsule endomicroscopy as a screening method for Barrett's esophagus (BE) in the primary care practice environment. The investigators are also determining the prevalence of Barrett's esophagus in a primary care practice cohort at MGH.
Read the detailed description
The investigators have developed a tethered capsule OCT device intended as an inexpensive screening tool for BE. The capsule, which is attached to a thin, flexible tether, is reusable after being processed by a standard disinfection technique. Used without sedation, the capsule is swallowed by the participant and travels in the esophagus to the gastroesophageal junction (GEJ) via peristalsis. Cross-sectional microscopic OCT images of the entire esophagus are collected during transit. The total time needed for swallowing, imaging and retrieval does not exceed 10 minutes, with a total of 30 minutes for the procedure. The investigators have tested the feasibility and the tolerability of this new OCT screening technology in 250 procedures in healthy volunteers and participants with various esophageal diseases including BE. The procedure has been safe and well tolerated. High quality microscopic images of the esophagus have been obtained in 90% of the enrolled participants.
- Conditions
- Barrett Esophagus, Barrett's Esophagus Without Dysplasia, Barretts Esophagus With Dysplasia
- Being tested
- Tethered Capsule Endomicroscopy
- Keywords
- OCT, Optical Coherence Tomography, Endomicroscopy, Capsule Endomicroscopy, Tethered Capsule Endomicroscopy, TCE
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tethered Capsule EndomicroscopyDevice
Participants will be asked to swallow the TCE device. Participants may use mild numbing spray, and lubrication spray to help swallowing. Imaging will be conducted once the TCE device is past the pharynx. The TCE device will be advanced until the stomach and then slowly pull the TCE back up the esophagus. This may be repeated twice.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility of TCE & Prevalence of BE | Experimental | 1. Feasibility of using tethered capsule endomicroscopy as a screening method for Barrett's esophagus in the primary care practice environment
2. Determine the prevalence of Barrett's esophagus in a primary care practice cohort at MGH Receives: Device: Tethered Capsule Endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Tolerability of Tethered Capsule Endomicroscopy Swallow
The study team will ask the participant about their comfort level throughout the procedure. Participants will be asked to score the tolerability of the procedure using a scoring system from 0-10. 0= the least tolerable, 10= the most tolerable. The title of the scale is Subject Tolerability Questionnaire.
Measured: During the single study visit (avg 30.mins), and before leaving, the participant will fill out the tolerability survey
Prevalence of Barrett's esophagus within the single Primary Care Practice cohort.
The PI will identify signs of Barrett's esophagus from the imaging data. This is a qualitative assessment performed by the PI, as this imaging technique is to novel to have standard quality grading.
Measured: Imaging data is collected during the procedure, and analyzed within 1 year of collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start2 Jan 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett 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
- 650 participants (estimated)
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, M.D, PhD., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561791
- Sponsor's protocol ID
- 2018P002403
- Status last verified
- Oct 2025
- First submitted
- 11 Aug 2020
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tethered Capsule Endomicroscopy as a Screening Tool for Barrett's Esophagus in the Primary Care Setting
- ClinicalTrials.gov ID
- NCT04561791
- Acronym / sponsor ID
- 2018P002403
- Conditions
- Barrett Esophagus, Barrett's Esophagus Without Dysplasia, Barretts Esophagus With Dysplasia
- Keywords
- OCT, Optical Coherence Tomography, Endomicroscopy, Capsule Endomicroscopy, Tethered Capsule Endomicroscopy, TCE
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 24 Sep 2020 (actual)
- 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 investigators will conduct a large study in the primary care clinic to determine the feasibility of using tethered capsule endomicroscopy as a screening method for Barrett's esophagus (BE) in the primary care practice environment. The investigators are also determining the prevalence of Barrett's esophagus in a primary care practice cohort at MGH.
Detailed description
The investigators have developed a tethered capsule OCT device intended as an inexpensive screening tool for BE. The capsule, which is attached to a thin, flexible tether, is reusable after being processed by a standard disinfection technique. Used without sedation, the capsule is swallowed by the participant and travels in the esophagus to the gastroesophageal junction (GEJ) via peristalsis. Cross-sectional microscopic OCT images of the entire esophagus are collected during transit. The total time needed for swallowing, imaging and retrieval does not exceed 10 minutes, with a total of 30 minutes for the procedure. The investigators have tested the feasibility and the tolerability of this new OCT screening technology in 250 procedures in healthy volunteers and participants with various esophageal diseases including BE. The procedure has been safe and well tolerated. High quality microscopic images of the esophagus have been obtained in 90% of the enrolled participants.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility of TCE & Prevalence of BE | Experimental | Device: Tethered Capsule Endomicroscopy1. Feasibility of using tethered capsule endomicroscopy as a screening method for Barrett's esophagus in the primary care practice environment 2. Determine the prevalence of Barrett's esophagus in a primary care practice cohort at MGH |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants registered as patients at the Assembly Row primary care practice, MGH Broadway Primary Care - Revere, or Pentucket Medical Associates
- 18 years or older
- Able to give informed consent
- Participants must have no food for 1 hour before the procedure
Key exclusion criteria (5 listed)
- Participants older than 75 years.
- Participants with current symptoms of dysphagia
- Participants with gastro-intestinal strictures with a diameter less than 8mm, prior GI surgery (Esophageal and/or stomach surgeries), or history of intestinal Crohn's disease
- Pregnancy
- Participants scheduled for an urgent care visit for the following symptoms: fever, sore throat, upper respiratory infection symptoms, nausea, vomiting, diarrhea, abdominal pain, or other symptoms as per clinical staff discretion.
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 |
|---|---|---|
| Tethered Capsule EndomicroscopyParticipants will be asked to swallow the TCE device. Participants may use mild numbing spray, and lubrication spray to help swallowing. Imaging will be conducted once the TCE device is past the pharynx. The TCE device will be advanced until the stomach and then slowly pull the TCE back up the esophagus. This may be repeated twice. | Device | Feasibility of TCE & Prevalence of BE |
Primary outcome
Subject Tolerability of Tethered Capsule Endomicroscopy Swallow
Time frame: During the single study visit (avg 30.mins), and before leaving, the participant will fill out the tolerability survey
The study team will ask the participant about their comfort level throughout the procedure. Participants will be asked to score the tolerability of the procedure using a scoring system from 0-10. 0= the least tolerable, 10= the most tolerable. The title of the scale is Subject Tolerability Questionnaire.
Prevalence of Barrett's esophagus within the single Primary Care Practice cohort.
Time frame: Imaging data is collected during the procedure, and analyzed within 1 year of collection.
The PI will identify signs of Barrett's esophagus from the imaging data. This is a qualitative assessment performed by the PI, as this imaging technique is to novel to have standard quality grading.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Barrett Esophagus
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"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
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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.
Guillermo Tearney, M.D, 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 Tethered Capsule Endomicroscopy in people with Barrett Esophagus and Barrett's Esophagus Without Dysplasia, 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 4 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 22 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Subject Tolerability of Tethered Capsule Endomicroscopy Swallow (time frame: During the single study visit (avg 30.mins), and before leaving, the participant will fill out the tolerability survey). The study lists 2 primary outcomes in all. 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 Oct 2025.