Barrett EsophagusNCT03670134
Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia
A study testing The Nvision VLE Imaging System in people with Barrett Esophagus, run by Mayo Clinic.
Trial summary
Researchers are trying to see if the Nvision® Imaging System (VLE) can accurately determine the risk of recurrent Barrett's esophagus in patients with Barrett's esophagus which have been clear of disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- The Nvision VLE Imaging System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 Aug 2018to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient undergoing an upper endoscopy with prior biopsy confirmed Barrett's Esophagus.
- Ability to provide written, informed consent
- No significant esophagitis (LA grade <B, C, and D)
Who cannot join
- Patients for whom use of the NvisionVLE device would be in conflict with the instruction for use.
- Prior esophageal or gastric surgical resection
- Significant esophageal stricture requiring dilatation
- Patients who require anti-coagulation for who biopsy would be contraindicated
- Patients who are known to be pregnant
About this study
Official title: The Use of Volumetric Laser Endomicroscopy to Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia
Researchers are trying to see if the Nvision® Imaging System (VLE) can accurately determine the risk of recurrent Barrett's esophagus in patients with Barrett's esophagus which have been clear of disease.
Read the detailed description
Patients with Barrett's Esophagus (BE) undergoing endoscopic therapy through our Barrett's Esophagus Unit will be approached for study enrollment. Patients with no endoscopic evidence of BE will be considered for the study. Surveillance biopsies will be obtained per standard clinical protocol and reviewed to confirm absence of intestinal metaplasia. Patients who have achieved complete eradication of intestinal metaplasia (CRIM) will be enrolled in the study and will undergo the Nvision® Imaging System (VLE). Patients enrolled in the study will undergo clinical follow-up consisting of surveillance endoscopy every 3 months for 1 year. Surveillance endoscopy intervals may be prolonged to every 6 months in the second year, and annually thereafter. At each follow-up visit, endoscopic data will be collected to determine if patients remain in CRIM or show evidence of recurrent disease. Patients will be followed for 1 year (endpoint 1) and 3 years (endpoint 2).
.
- Conditions
- Barrett Esophagus
- Being tested
- The Nvision VLE Imaging System
- Keywords
- Laser Endomicroscopy, Intestinal Metaplasia
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Nvision VLE Imaging SystemDevice
Volumetric laser Endomicroscopy (VLE) will be performed by using the Nvision VLE Imaging System (Nine Point Medical, MA) consists of an imaging console, monitor and optical probe. The optical probe is centered by a balloon (diameter: 14 mm, 17 mm, 20 mm; length: 6 cm) that is deployed through a diagnostic gastroscope's instrument channel. Imaging is performed by automatic helical pullback of the probe from the distal to the proximal end of the balloon over 90 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Volumetric laser Endomicroscopy (VLE) | Experimental | Volumetric laser Endomicroscopy (VLE) is a second-generation optical coherence tomography platform that can image the human esophagus in cross-section at microscopic resolution this will performed by using the Nvision VLE Imaging System. Receives: Device: The Nvision VLE Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine association between number of glandular structures measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy
Measure the number of glandular structures observed with volumetric laser endomicroscopy in patients who remain free of Barrett's esophagus and in those with recurrent disease. Report the mean and standard-deviation of this metric and determine a statistical significant difference using the Student's t-test.
Measured: 1 year
Determine association between distribution of glandular structures measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy
Measure the distribution (gastric cardia versus esophagus) of glandular structures observed with volumetric laser endomicroscopy in patients who remain free of Barrett's esophagus and in those with recurrent disease. Report the mean and standard-deviation of this metric and determine a statistical significant difference using the Student's t-test.
Measured: 1 year
Determine association between thickness of neosquamous epithelium measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy
Measure the thickness of neosquamous epithelium (mm) with volumetric laser endomicroscopy in patients who remain free of Barrett's esophagus and in those with recurrent disease. Report the mean and standard-deviation of this metric and determine a statistical significant difference using the Student's t-test.
Measured: 1 year
Secondary outcomes (1)
Develop a volumetric laser endomicrosopy feature scoring index to stratify the risk of disease recurrence in patients with Barrett's esophagus following treatment
The proposed model will stratify patients into two categories (1) low risk of recurrence and (2) high risk of recurrence. Low risk of disease recurrence is defined by a rate of <5% per patient-year. High risk of disease recurrence is defined by a rate of >10% per patient year.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start6 Aug 2018
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: The company that supported the technology (volumetric laser endomicroscopy) is no longer operational due to the pandemic.
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 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
- Responsible party
- Principal investigator, Cadman Leggett, Mayo Clinic
- Investigators
- Cadman L Leggett, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670134
- Sponsor's protocol ID
- 18-003333
- Status last verified
- Mar 2022
- First submitted
- 30 Aug 2018
- Last updated
- 31 Mar 2022
- 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Volumetric Laser Endomicroscopy to Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia
- ClinicalTrials.gov ID
- NCT03670134
- Acronym / sponsor ID
- 18-003333
- Conditions
- Barrett Esophagus
- Keywords
- Laser Endomicroscopy, Intestinal Metaplasia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The company that supported the technology (volumetric laser endomicroscopy) is no longer operational due to the pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 13 Sep 2018 (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.
Researchers are trying to see if the Nvision® Imaging System (VLE) can accurately determine the risk of recurrent Barrett's esophagus in patients with Barrett's esophagus which have been clear of disease.
Detailed description
Patients with Barrett's Esophagus (BE) undergoing endoscopic therapy through our Barrett's Esophagus Unit will be approached for study enrollment. Patients with no endoscopic evidence of BE will be considered for the study. Surveillance biopsies will be obtained per standard clinical protocol and reviewed to confirm absence of intestinal metaplasia. Patients who have achieved complete eradication of intestinal metaplasia (CRIM) will be enrolled in the study and will undergo the Nvision® Imaging System (VLE). Patients enrolled in the study will undergo clinical follow-up consisting of surveillance endoscopy every 3 months for 1 year. Surveillance endoscopy intervals may be prolonged to every 6 months in the second year, and annually thereafter. At each follow-up visit, endoscopic data will be collected to determine if patients remain in CRIM or show evidence of recurrent disease. Patients will be followed for 1 year (endpoint 1) and 3 years (endpoint 2).
.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volumetric laser Endomicroscopy (VLE) | Experimental | Device: The Nvision VLE Imaging SystemVolumetric laser Endomicroscopy (VLE) is a second-generation optical coherence tomography platform that can image the human esophagus in cross-section at microscopic resolution this will performed by using the Nvision VLE 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)
- Patient undergoing an upper endoscopy with prior biopsy confirmed Barrett's Esophagus.
- Ability to provide written, informed consent
- No significant esophagitis (LA grade <B, C, and D)
Key exclusion criteria (5 listed)
- Patients for whom use of the NvisionVLE device would be in conflict with the instruction for use.
- Prior esophageal or gastric surgical resection
- Significant esophageal stricture requiring dilatation
- Patients who require anti-coagulation for who biopsy would be contraindicated
- Patients who are known to be pregnant
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 |
|---|---|---|
| The Nvision VLE Imaging SystemVolumetric laser Endomicroscopy (VLE) will be performed by using the Nvision VLE Imaging System (Nine Point Medical, MA) consists of an imaging console, monitor and optical probe. The optical probe is centered by a balloon (diameter: 14 mm, 17 mm, 20 mm; length: 6 cm) that is deployed through a diagnostic gastroscope's instrument channel. Imaging is performed by automatic helical pullback of the probe from the distal to the proximal end of the balloon over 90 seconds. | Device | Volumetric laser Endomicroscopy (VLE) |
Primary outcome
Determine association between number of glandular structures measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy
Time frame: 1 year
Measure the number of glandular structures observed with volumetric laser endomicroscopy in patients who remain free of Barrett's esophagus and in those with recurrent disease. Report the mean and standard-deviation of this metric and determine a statistical significant difference using the Student's t-test.
Determine association between distribution of glandular structures measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy
Time frame: 1 year
Measure the distribution (gastric cardia versus esophagus) of glandular structures observed with volumetric laser endomicroscopy in patients who remain free of Barrett's esophagus and in those with recurrent disease. Report the mean and standard-deviation of this metric and determine a statistical significant difference using the Student's t-test.
Determine association between thickness of neosquamous epithelium measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy
Time frame: 1 year
Measure the thickness of neosquamous epithelium (mm) with volumetric laser endomicroscopy in patients who remain free of Barrett's esophagus and in those with recurrent disease. Report the mean and standard-deviation of this metric and determine a statistical significant difference using the Student's t-test.
1 secondary outcome
Develop a volumetric laser endomicrosopy feature scoring index to stratify the risk of disease recurrence in patients with Barrett's esophagus following treatment
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Cadman L Leggett, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing The Nvision VLE Imaging System in people with Barrett Esophagus, run by Mayo Clinic.
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 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: withdrawn, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Determine association between number of glandular structures measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy (time frame: 1 year). The study lists 3 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 31 Mar 2022.