Barrett's EsophagusDDPNCT02864043
Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System
A study testing NvisionVLE with Real Time Targeting and esophagogastroduodenoscopy (EGD) in people with Barrett's Esophagus, run by NinePoint Medical at 5 sites in United States.
Trial summary
The NvisionVLE® Dysplasia Detection Pilot Study is a prospective, non-randomized trial for participants who have a prior biopsy-confirmed diagnosis of BE with dysplasia and are scheduled to have an endoscopic evaluation of your esophagus for BE surveillance by a standard procedure called EGD… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- NvisionVLE with Real Time Targeting and esophagogastroduodenoscopy (EGD)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2016to 1 Jun 2020
- 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
- Patients over the age of 18.
- Patients undergoing an upper endoscopy for BE surveillance with prior biopsy-confirmed BE with dysplasia (at least LGD).
- Ability to provide written, informed consent.
- No significant esophagitis (LA grade < B, C and D).
Who cannot join
- Patients who have achieved complete remission of intestinal metaplasia (CR-IM)
- Patients without visible BE at time of study EGD.
- Patients for whom use of the NvisionVLE device would be in conflict with the Instructions for Use (IFU).
- Prior esophageal or gastric surgical resection.
- Significant esophageal stricture requiring dilatation.
- Patients who require anticoagulation for whom biopsy would be contraindicated.
- Patients who are known to be pregnant.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
VA Boston
Boston, Massachusetts, 02130
UC Irvine Medical Center
Irvine, California, 92617
North Shore University Hospital
Manhasset, New York, 11030
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Mayo Clinic
Rochester, Minnesota, 55901
About this study
Official title: Identification of Features Associated With Dysplasia Using the NvisionVLE® Imaging System Pilot Trial
The NvisionVLE® Dysplasia Detection Pilot Study is a prospective, non-randomized trial for participants who have a prior biopsy-confirmed diagnosis of BE with dysplasia and are scheduled to have an endoscopic evaluation of your esophagus for BE surveillance by a standard procedure called EGD (esophagogastroduodenoscopy) as well as an imaging procedure called VLE (volumetric laser endomicroscopy).
Read the detailed description
The NvisionVLE® Dysplasia Detection Pilot Study is a collection of data for research. Participation is completely voluntary and does not affect the patient's medical care that chooses not to participate. The purpose of this Study is to determine the performance of the NvisionVLE® Imaging System in determining features of dysplastic Barrett's Esophagus (BE). This is done by the collection and analysis of the medical record information, imaging data, and pathology results. The information is then stored and may be used at a later time for various future analyses and publications. Any future analyses involving this Study will only use the information collected in this Study. No further involvement or additional informed consent of participants will be needed if future analyses are performed.
This Study is designed for participants who have a prior biopsy-confirmed diagnosis of BE with dysplasia and are scheduled to have an endoscopic evaluation of your esophagus for BE surveillance by a standard procedure called EGD (esophagogastroduodenoscopy) as well as an imaging procedure called VLE (volumetric laser endomicroscopy).
The NvisionVLE® Imaging System is cleared for use by the U.S. Food and Drug Administration (FDA).
Patients who undergo an endoscopic evaluation of the esophagus with the NvisionVLE® Imaging System at participating hospitals will be invited to participate in this Study. The Study is taking place at up to 4 hospitals, and as many as 100 patients may participate in this Study.
- Conditions
- Barrett's Esophagus
- Being tested
- NvisionVLE with Real Time Targeting, esophagogastroduodenoscopy (EGD)
- Keywords
- Barrett's Esophagus, Barrett's, OCT, VLE
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NvisionVLE with Real Time TargetingDevice
Physician will complete a VLE scan of the esophagus and target areas of interest using the VLE optical marking probe
esophagogastroduodenoscopy (EGD)Procedure or surgery
Standard of care EGD
| Study group | Role | What they receive |
|---|---|---|
| EGD with NvisionVLE with Real Time Targeting | Other | Physician will complete a VLE scan of the esophagus and target areas of interest using the VLE optical marking probe following standard of care endoscopy Receives: Device: NvisionVLE with Real Time Targeting; Procedure: esophagogastroduodenoscopy (EGD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of manually identified VLE features in predicting biopsy defined dysplasia
To determine the per-biopsy performance of a multivariable model consisting of manually-identified VLE features for predicting biopsy-defined dysplasia
Measured: Up to 2 years post data collection
Secondary outcomes (3)
Per Patient Sensitivity and specificity for detecting dysplasia
- To determine the absolute per-patient sensitivity and specificity of a multivariable model consisting of manually-identified VLE features for predicting biopsy-defined dysplasia.
Measured: Up to 2 years post data collection
Per Biopsy Sensitivity and specificity for detecting dysplasia
- To determine the absolute per-biopsy sensitivity and specificity of a multivariable model consisting of manually-identified VLE features for predicting biopsy-defined dysplasia.
Measured: Up to 2 years post data collection
Per Biopsy performance of VLE compared to standard-of-care for detecting dysplasia
- To compare, on a per-biopsy basis, the performance of VLE and standard-of-care to standard-of-care alone in detecting dysplasia.
Measured: Up to 2 years post data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startSep 2016
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (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.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- NinePoint Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Wang, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864043
- Sponsor's protocol ID
- 16-01
- Acronym
- DDP
- Status last verified
- Mar 2020
- First submitted
- 2 Aug 2016
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Features Associated With Dysplasia Using the NvisionVLE® Imaging System Pilot Trial
- ClinicalTrials.gov ID
- NCT02864043
- Acronym / sponsor ID
- DDP / 16-01
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's Esophagus, Barrett's, OCT, VLE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- NinePoint MedicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 11 Aug 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 NvisionVLE® Dysplasia Detection Pilot Study is a prospective, non-randomized trial for participants who have a prior biopsy-confirmed diagnosis of BE with dysplasia and are scheduled to have an endoscopic evaluation of your esophagus for BE surveillance by a standard procedure called EGD (esophagogastroduodenoscopy) as well as an imaging procedure called VLE (volumetric laser endomicroscopy).
Detailed description
The NvisionVLE® Dysplasia Detection Pilot Study is a collection of data for research. Participation is completely voluntary and does not affect the patient's medical care that chooses not to participate. The purpose of this Study is to determine the performance of the NvisionVLE® Imaging System in determining features of dysplastic Barrett's Esophagus (BE). This is done by the collection and analysis of the medical record information, imaging data, and pathology results. The information is then stored and may be used at a later time for various future analyses and publications. Any future analyses involving this Study will only use the information collected in this Study. No further involvement or additional informed consent of participants will be needed if future analyses are performed.
This Study is designed for participants who have a prior biopsy-confirmed diagnosis of BE with dysplasia and are scheduled to have an endoscopic evaluation of your esophagus for BE surveillance by a standard procedure called EGD (esophagogastroduodenoscopy) as well as an imaging procedure called VLE (volumetric laser endomicroscopy).
The NvisionVLE® Imaging System is cleared for use by the U.S. Food and Drug Administration (FDA).
Patients who undergo an endoscopic evaluation of the esophagus with the NvisionVLE® Imaging System at participating hospitals will be invited to participate in this Study. The Study is taking place at up to 4 hospitals, and as many as 100 patients may participate in this Study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGD with NvisionVLE with Real Time Targeting | Other | Device: NvisionVLE with Real Time Targeting, Procedure: esophagogastroduodenoscopy (EGD)Physician will complete a VLE scan of the esophagus and target areas of interest using the VLE optical marking probe following standard of care endoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over the age of 18.
- Patients undergoing an upper endoscopy for BE surveillance with prior biopsy-confirmed BE with dysplasia (at least LGD).
- Ability to provide written, informed consent.
- No significant esophagitis (LA grade < B, C and D).
Key exclusion criteria (7 listed)
- Patients who have achieved complete remission of intestinal metaplasia (CR-IM)
- Patients without visible BE at time of study EGD.
- Patients for whom use of the NvisionVLE device would be in conflict with the Instructions for Use (IFU).
- Prior esophageal or gastric surgical resection.
- Significant esophageal stricture requiring dilatation.
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 |
|---|---|---|
| NvisionVLE with Real Time TargetingPhysician will complete a VLE scan of the esophagus and target areas of interest using the VLE optical marking probe | Device | EGD with NvisionVLE with Real Time Targeting |
| esophagogastroduodenoscopy (EGD)Standard of care EGD | Procedure or surgery | EGD with NvisionVLE with Real Time Targeting |
Primary outcome
Performance of manually identified VLE features in predicting biopsy defined dysplasia
Time frame: Up to 2 years post data collection
To determine the per-biopsy performance of a multivariable model consisting of manually-identified VLE features for predicting biopsy-defined dysplasia
3 secondary outcomes
Per Patient Sensitivity and specificity for detecting dysplasia
Time frame: Up to 2 years post data collection
Per Biopsy Sensitivity and specificity for detecting dysplasia
Time frame: Up to 2 years post data collection
Per Biopsy performance of VLE compared to standard-of-care for detecting dysplasia
Time frame: Up to 2 years post data collection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- 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.
Kenneth Wang, MD principal investigator
Mayo Clinic
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NvisionVLE with Real Time Targeting and esophagogastroduodenoscopy (EGD) in people with Barrett's Esophagus, run by NinePoint Medical at 5 sites 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 7 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: status not confirmed, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
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?
Performance of manually identified VLE features in predicting biopsy defined dysplasia (time frame: Up to 2 years post data collection). 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 4 Mar 2020.