Barrett EsophagusNCT02994693
Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
An observational study of Barrett Esophagus and Barretts Esophagus With Dysplasia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this research is to determine the natural history of Barrett's esophagus (BE) using tethered capsule endomicroscopy (TCE) in participants undergoing surveillance endoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus, Barretts Esophagus With Dysplasia
- What is being tested?
- OFDI capsule imaging
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Dec 2029
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with known BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy.
Who may be able to join
- Participants with known BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy,
- Participants over the age of 18
- Participants who are capable of giving informed consent
- Participants who had or will have a standard of care EGD within 9 to 15 months
- Participants must have no solid food for at least 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.
Who cannot join
- Participants with prior endoscopic ablation or resection treatment of BE
- Participants with esophageal fistula and/or esophageal strictures with a luminal stricture diameter that is smaller than the diameter of the capsule
- Participants with the inability to swallow capsules.
- Pregnancy, according to participant information
- Thrombocytopenia, coagulopathy, previous bone marrow transplant
- History or diagnosis of leukemia
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The goal of this research is to determine the natural history of Barrett's esophagus (BE) using tethered capsule endomicroscopy (TCE) in participants undergoing surveillance endoscopy.
Read the detailed description
The MGH will be the first site in the multi-center study to begin enrolling. At the MGH 100 participants with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled.
Each subject will undergo a minimum of 2 esophagogastroduodenoscopies (EGD), one around the time of inclusion into the study and one at the end of the study, and 4 TCE imaging sessions (baseline, 1-year, 2-years and at the end of the 3-years follow-up). If it is determined by the treating physician that additional EGDs are needed, for extended follow-up or treatment, capsule imaging will be performed whenever possible.
Participants will have received written information prior to the day of the capsule procedure and participants will have another chance to discuss the procedure with the study coordinator and clinical study staff during the consent process prior to the capsule procedure. Participation in this study is completely voluntary, and the participant can stop the procedure at any time.
For each of the imaged participants, inclusion criteria and clinical characteristics such as age, sex, body mass index (BMI), current medication regimen, smoking history and GI related history will be recorded in the clinical form.
Participants will be seated and asked to sip water to facilitate swallowing the capsule.
The device will be operated by experienced study staff trained in the procedure such as a registered nurse or one of the endoscopist co-investigators in this study. Emergency phone and/or pager contact of the collaborating GI clinician(s) will be provided. They will also be accessible during the procedure if any problems are encountered that require their expertise.
Imaging will be performed in the same manner as in our other current IRB approved tethered capsule endomicroscopy studies. The capsule position will be controlled manually via the tether outside of the participant's mouth by the catheter operator. Recorded real-time cross-sectional images displayed on the monitor and distance marks on the tether will be used for confirmation of capsule position in the esophagus. Images will be viewed in real time to determine when the capsule has reached the stomach. The resistance of the tether can also give information of the cardia position. Once in the stomach, the capsule will be gradually pulled back up through the esophagus to the mouth, also while imaging. The capsule may be repositioned for imaging up to 4 times up and 4 times down the esophagus. The participant may be asked to swallow a different size capsule (ranging from 5-12.8 mm in diameter and 20-30 cm in length) to obtain the best distal esophageal images. It is expected that the maximum experimental time including swallowing the capsule, the imaging procedure, and removal of the capsule will take approximately 10 minutes in total.
- Being tested
- OFDI capsule imaging
- Keywords
- Barrett's Esophagus, Natural History, Device, OCT, Capsule, Tethered Capsule Endomicroscopy
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OFDI capsule imagingDevice
Imaging of Barrett's esophagus (BE) using OFDI capsule imaging
| Study group | Role | What they receive |
|---|---|---|
| OFDI capsule imaging | Participants will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system. Receives: Device: OFDI capsule imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal assessment of the Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. They will assess how the images change over time.
Measured: Approximate 25 minutes visit (10 min image acquisition)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
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
- NCT02994693
- Sponsor's protocol ID
- 2016-P000919
- Other IDs
- 5R01CA184102-02
- Status last verified
- Sep 2026
- First submitted
- 13 Dec 2016
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Dong J, Grant C, Vuong B, Nishioka N, Gao AH, Beatty M, Baldwin G, Baillargeon A, Bablouzian A, Grahmann P, Bhat N, Ryan E, Barrios A, Giddings S, Ford T, Beaulieu-Ouellet E, Hosseiny SH, Lerman I, Trasischker W, Reddy R, Singh K, Gora M, Hyun D, Queneherve L, Wallace M, Wolfsen H, Sharma P, Wang KK, Leggett CL, Poneros J, Abrams JA, Lightdale C, Leeds S, Rosenberg M, Tearney GJ. Feasibility and Safety of Tethered Capsule Endomicroscopy in Patients With Barrett's Esophagus in a Multi-Center Study. Clin Gastroenterol Hepatol. 2022 Apr;20(4):756-765.e3. doi: 10.1016/j.cgh.2021.02.008. Epub 2021 Feb 4.
PubMed 33549871
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
- ClinicalTrials.gov ID
- NCT02994693
- Acronym / sponsor ID
- 2016-P000919
- Keywords
- Barrett's Esophagus, Natural History, Device, OCT, Capsule, Tethered Capsule Endomicroscopy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 16 Dec 2016 (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 goal of this research is to determine the natural history of Barrett's esophagus (BE) using tethered capsule endomicroscopy (TCE) in participants undergoing surveillance endoscopy.
Detailed description
The MGH will be the first site in the multi-center study to begin enrolling. At the MGH 100 participants with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled.
Each subject will undergo a minimum of 2 esophagogastroduodenoscopies (EGD), one around the time of inclusion into the study and one at the end of the study, and 4 TCE imaging sessions (baseline, 1-year, 2-years and at the end of the 3-years follow-up). If it is determined by the treating physician that additional EGDs are needed, for extended follow-up or treatment, capsule imaging will be performed whenever possible.
Participants will have received written information prior to the day of the capsule procedure and participants will have another chance to discuss the procedure with the study coordinator and clinical study staff during the consent process prior to the capsule procedure. Participation in this study is completely voluntary, and the participant can stop the procedure at any time.
For each of the imaged participants, inclusion criteria and clinical characteristics such as age, sex, body mass index (BMI), current medication regimen, smoking history and GI related history will be recorded in the clinical form.
Participants will be seated and asked to sip water to facilitate swallowing the capsule.
The device will be operated by experienced study staff trained in the procedure such as a registered nurse or one of the endoscopist co-investigators in this study. Emergency phone and/or pager contact of the collaborating GI clinician(s) will be provided. They will also be accessible during the procedure if any problems are encountered that require their expertise.
Imaging will be performed in the same manner as in our other current IRB approved tethered capsule endomicroscopy studies. The capsule position will be controlled manually via the tether outside of the participant's mouth by the catheter operator. Recorded real-time cross-sectional images displayed on the monitor and distance marks on the tether will be used for confirmation of capsule position in the esophagus. Images will be viewed in real time to determine when the capsule has reached the stomach. The resistance of the tether can also give information of the cardia position. Once in the stomach, the capsule will be gradually pulled back up through the esophagus to the mouth, also while imaging. The capsule may be repositioned for imaging up to 4 times up and 4 times down the esophagus. The participant may be asked to swallow a different size capsule (ranging from 5-12.8 mm in diameter and 20-30 cm in length) to obtain the best distal esophageal images. It is expected that the maximum experimental time including swallowing the capsule, the imaging procedure, and removal of the capsule will take approximately 10 minutes in total.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OFDI capsule imaging | – | Device: OFDI capsule imagingParticipants will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with known BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy.
Key inclusion criteria (5 listed)
- Participants with known BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy,
- Participants over the age of 18
- Participants who are capable of giving informed consent
- Participants who had or will have a standard of care EGD within 9 to 15 months
- Participants must have no solid food for at least 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.
Key exclusion criteria (6 listed)
- Participants with prior endoscopic ablation or resection treatment of BE
- Participants with esophageal fistula and/or esophageal strictures with a luminal stricture diameter that is smaller than the diameter of the capsule
- Participants with the inability to swallow capsules.
- Pregnancy, according to participant information
- Thrombocytopenia, coagulopathy, previous bone marrow transplant
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 capsule imagingImaging of Barrett's esophagus (BE) using OFDI capsule imaging | Device | OFDI capsule imaging |
Primary outcome
Longitudinal assessment of the Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Time frame: Approximate 25 minutes visit (10 min image acquisition)
An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. They will assess how the images change over time.
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 2 Oct 2026.
- Derived from this study: PubMed 33549871Dong J, Grant C, Vuong B, Nishioka N, Gao AH, Beatty M, Baldwin G, Baillargeon A, Bablouzian A, Grahmann P, Bhat N, Ryan E, Barrios A, Giddings S, Ford T, Beaulieu-Ouellet E, Hosseiny SH, Lerman I, Trasischker W, Reddy R, Singh K, Gora M, Hyun D, Queneherve L, Wallace M, Wolfsen H, Sharma P, Wang KK, Leggett CL, Poneros J, Abrams JA, Lightdale C, Leeds S, Rosenberg M, Tearney GJ. Feasibility and Safety of Tethered Capsule Endomicroscopy in Patients With Barrett's Esophagus in a Multi-Center Study. Clin Gastroenterol Hepatol. 2022 Apr;20(4):756-765.e3. doi: 10.1016/j.cgh.2021.02.008. Epub 2021 Feb 4.
- 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?
An observational study of Barrett Esophagus and Barretts Esophagus With 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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. 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?
Longitudinal assessment of the Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy (time frame: Approximate 25 minutes visit (10 min image acquisition)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02994693, which also lists 1 linked publication.
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 2 Oct 2026.