Barrett's EsophagusDS-MCE-BENCT06748911
Navicam for Detection of Barrett's Esophagus
A study testing NaviCam Detachable String Capsule in people with Barrett's Esophagus, run by Mayo Clinic at 1 site in United States.
Trial summary
Using a non-invasive capsule system to achieve optimal viewing angles of the esophagus for detection of Barrett's esophagus Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- NaviCam Detachable String Capsule
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2025to 30 Sep 2026
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults greater than or equal to 22 years of age with or without Barrett's Esophagus
- All Patients:
- o Have had an endoscopy within 1 year of baseline enrollment
- Patients with Barrett's Esophagus:
- Presence of at least 1cm of salmon colored mucosa with corresponding biopsies showing intestinal metaplasia who are treatment naïve and undergoing surveillance Or
- Chronic Gastro Esophageal Reflux Disease (GERD) patients with at least 3 additional risk factors that meet Barrett's Esophagus screening criteria per latest clinical guidelines
Who cannot join
- Inability to comprehend or read the consent form
- Have an oropharynx, esophageal, or gastro-esophageal tumor
- Ongoing symptoms of dysphagia
- Presence of active clinically significant stricture
- History of stricture requiring dilation
- Presence of pacemaker or implanted cardiac defibrillator
Show all 10Show fewer
- History of esophageal surgery with the exception of fundoplication
- Pregnancy
- History of surgery or obstructive process of the small bowel
- BMI > 38
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, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Stephanie McNew, B.S., 904-953-0580, mcnew.stephanie@mayo.edu
Swathi Eluri
About this study
Official title: Use of a Detachable String Capsule for Evaluation of Barrett's Esophagus
Using a non-invasive capsule system to achieve optimal viewing angles of the esophagus for detection of Barrett's esophagus
- Conditions
- Barrett's Esophagus
- Being tested
- NaviCam Detachable String Capsule
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaviCam Detachable String CapsuleDevice
Subjects will swallow the NaviCam capsule with 20 ml water while positioned in the upright position. Once the capsule reaches the gastric cardia, the string will slowly be pulled up to systematically inspect the Z-line and upper, middle, and lower thirds of the esophagus guided by real-time viewing and by moving the capsule solely with the tether. Images will be captured at a rate of 2 frames per second.
| Study group | Role | What they receive |
|---|---|---|
| Long Segment Barrett's Esophagus (LSBE) | Experimental | Subjects diagnosed with Long Segment Barrett's Esophagus (LSBE) Receives: Device: NaviCam Detachable String Capsule |
| Short Segment Barrett's Esophagus (SSBE) | Experimental | Subjects diagnosed with Short Segment Barrett's Esophagus (SSBE) Receives: Device: NaviCam Detachable String Capsule |
| Gastro Esophageal Reflux Disease | Experimental | Subjects with Gastro Esophageal Reflux Disease (GERD) who are eligible for Barrett's Esophagus screening Receives: Device: NaviCam Detachable String Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Columnar lined epithelium in the esophagus
Detection of Columnar lined epithelium in the esophagus
Measured: From start of procedure to removal of capsule, assessed up to 30 minutes timeframe from start to end of procedure..
Secondary outcomes (3)
Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) is an 11-tem questionnaire assessing pain, where 0 represents the "worst experience" and 10 the "best experience". Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain.
Measured: 30 minutes post-procedure
Spielberger State-Trait Anxiety Inventory (STAI-6)
Patient anxiety will be measured using the shorter 6 item form of the Spielberger State-Trait Anxiety Inventory (STAI-6), with a score over 40 as a threshold for clinically significant anxiety
Measured: Baseline, 30 minutes post-procedure
Impact of Events Scale (IES)
The Impact of Events Scale (IES) will be used to assess distress associated with the procedure and procedure acceptability. The IES is rated on a scale of 0 (not at all) to 4 (extremely), with higher scores indicating a greater level of distress.
Measured: Baseline, 7 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start20 Feb 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Swathi Eluri, Mayo Clinic
- Investigators
- Swathi Eluri, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748911
- Sponsor's protocol ID
- 24-000150
- Acronym
- DS-MCE-BE
- Status last verified
- Aug 2026
- First submitted
- 10 Dec 2024
- Last updated
- 19 Aug 2026
- 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Detachable String Capsule for Evaluation of Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT06748911
- Acronym / sponsor ID
- DS-MCE-BE / 24-000150
- Conditions
- Barrett's Esophagus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 27 Dec 2024 (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.
Using a non-invasive capsule system to achieve optimal viewing angles of the esophagus for detection of Barrett's esophagus
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Long Segment Barrett's Esophagus (LSBE) | Experimental | Device: NaviCam Detachable String CapsuleSubjects diagnosed with Long Segment Barrett's Esophagus (LSBE) |
| Short Segment Barrett's Esophagus (SSBE) | Experimental | Device: NaviCam Detachable String CapsuleSubjects diagnosed with Short Segment Barrett's Esophagus (SSBE) |
| Gastro Esophageal Reflux Disease | Experimental | Device: NaviCam Detachable String CapsuleSubjects with Gastro Esophageal Reflux Disease (GERD) who are eligible for Barrett's Esophagus screening |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults greater than or equal to 22 years of age with or without Barrett's Esophagus
- All Patients:
- o Have had an endoscopy within 1 year of baseline enrollment
- Patients with Barrett's Esophagus:
Key exclusion criteria (10 listed)
- Inability to comprehend or read the consent form
- Have an oropharynx, esophageal, or gastro-esophageal tumor
- Ongoing symptoms of dysphagia
- Presence of active clinically significant stricture
- History of stricture requiring dilation
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 |
|---|---|---|
| NaviCam Detachable String CapsuleSubjects will swallow the NaviCam capsule with 20 ml water while positioned in the upright position. Once the capsule reaches the gastric cardia, the string will slowly be pulled up to systematically inspect the Z-line and upper, middle, and lower thirds of the esophagus guided by real-time viewing and by moving the capsule solely with the tether. Images will be captured at a rate of 2 frames per second. | Device | Gastro Esophageal Reflux Disease, Long Segment Barrett's Esophagus (LSBE), Short Segment Barrett's Esophagus (SSBE) |
Primary outcome
Detection of Columnar lined epithelium in the esophagus
Time frame: From start of procedure to removal of capsule, assessed up to 30 minutes timeframe from start to end of procedure..
Detection of Columnar lined epithelium in the esophagus
3 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: 30 minutes post-procedure
Spielberger State-Trait Anxiety Inventory (STAI-6)
Time frame: Baseline, 30 minutes post-procedure
Impact of Events Scale (IES)
Time frame: Baseline, 7 days post-procedure
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 19 Aug 2026.
- 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.
Swathi Eluri principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NaviCam Detachable String Capsule in people with Barrett's Esophagus, run by Mayo Clinic 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 10 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: looking for participants now, as of the sponsor's last update on 19 Aug 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?
Contact Stephanie McNew (904-953-5080, McNew.Stephanie@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Columnar lined epithelium in the esophagus (time frame: From start of procedure to removal of capsule, assessed up to 30 minutes timeframe from start to end of 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 19 Aug 2026.