Barrett EsophagusNCT03434834
OCT Pilot in Esophagus
A study testing optical coherence tomography in people with Barrett Esophagus, run by Duke University at 1 site in United States.
Trial summary
This is a pilot study to test a newly developed optical coherence tomography (OCT) device to determine 1) whether adequate tissue contact can be attained to acquire high quality images, and 2) to identify if these images can discern whether the imaged tissue is squamous or Barrett's Esophagus (BE) epithelium. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- optical coherence tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2018to 25 Mar 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presenting to University of North Carolina (UNC) for routine care upper endoscopy
- Meet one of the following criteria:
- Presenting to UNC for upper endoscopy of GI conditions without esophageal symptomology for with no history of gastroesophageal reflux disease (GERD) or other esophageal condition affecting the epithelium (asymptomatic controls), OR,
- History of dysplastic or non-dysplastic Barrett's Esophagus with prague criteria C1+ or M3+
- Aged 18 to 80
- Able to read, comprehend, and understand the informed consent document.
Who cannot join
- Prior esophageal surgery (uncomplicated nissen fundoplication OK)
- Pregnant women
- Unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An Optical Coherence Tomography (OCT) Pilot Study
This is a pilot study to test a newly developed optical coherence tomography (OCT) device to determine 1) whether adequate tissue contact can be attained to acquire high quality images, and 2) to identify if these images can discern whether the imaged tissue is squamous or Barrett's Esophagus (BE) epithelium.
- Conditions
- Barrett Esophagus
- Being tested
- optical coherence tomography
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomographyDevice
OCT measurements of 5 locations in the esophagus
| Study group | Role | What they receive |
|---|---|---|
| OCT of esophagus | Experimental | optical coherence tomography of esophagus Receives: Device: optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa
Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy.
Measured: at baseline
Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa
Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy.
Measured: at baseline
Secondary outcomes (1)
Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image
Percentage of imaged sites that achieved adequate tissue contact to acquire high quality OCT images.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start25 Sep 2018
- Primary completion25 Feb 2020
- Study completion25 Mar 2020
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 EsophagusStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Adam Wax, Ph.D., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434834
- Sponsor's protocol ID
- Pro00090173
- Other IDs
- R01CA210544
- Status last verified
- Mar 2021
- First submitted
- 29 Jan 2018
- Last updated
- 6 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An Optical Coherence Tomography (OCT) Pilot Study
- ClinicalTrials.gov ID
- NCT03434834
- Acronym / sponsor ID
- Pro00090173
- Conditions
- Barrett Esophagus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, National Cancer Institute (NCI)
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Posted 6 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to test a newly developed optical coherence tomography (OCT) device to determine 1) whether adequate tissue contact can be attained to acquire high quality images, and 2) to identify if these images can discern whether the imaged tissue is squamous or Barrett's Esophagus (BE) epithelium.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCT of esophagus | Experimental | Device: optical coherence tomographyoptical coherence tomography of esophagus |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presenting to University of North Carolina (UNC) for routine care upper endoscopy
- Meet one of the following criteria:
- Aged 18 to 80
- Able to read, comprehend, and understand the informed consent document.
Key exclusion criteria (3 listed)
- Prior esophageal surgery (uncomplicated nissen fundoplication OK)
- Pregnant women
- Unable to provide written informed consent
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 |
|---|---|---|
| optical coherence tomographyOCT measurements of 5 locations in the esophagus | Device | OCT of esophagus |
Primary outcome
Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa
Time frame: at baseline
Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy.
Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa
Time frame: at baseline
Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy.
1 secondary outcome
Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image
Time frame: at baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Adam Wax, Ph.D. principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing optical coherence tomography in people with Barrett Esophagus, run by Duke University 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 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 6 Apr 2021. 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 6 Apr 2021). 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?
Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa (time frame: at baseline). 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 6 Apr 2021.