Barrett EsophagusNCT03015389
Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Tissue Analysis (WATS3D) For the Detection of High Grade Esophageal Dysplasia and Adenocarcinoma
An observational study of Barrett Esophagus and Esophageal Dysplasia, run by CDx Diagnostics at 1 site in Belgium.
Trial summary
This is a multi-center, prospective, randomized study which will enroll patients undergoing endoscopic surveillance due to a history of histologically confirmed dysplasia. A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus, Esophageal Dysplasia, Esophageal Adenocarcinoma
- What is being tested?
- Diagnostic Test
- Type of treatment
- Surgery or procedure
- How many people
- 170 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Sep 2017to 18 Feb 2019
- Phase
- Observational
- 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
Study population: Barrett's associated esophageal dysplasia
Who may be able to join
- Patients age: ≥ 18 years
- Patients should have a history of Barrett's associated esophageal dysplasia (either low or high-grade) confirmed on histology
- Willingness to undergo both WATS3D and random forceps biopsies while undergoing conventional EGD with sedation
- Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation
- Only patients who no visible mucosal abnormalities at the time that they undergo both random forceps biopsies and WATS3D testing of the esophagus will be included in this study
Who cannot join
- Coagulopathy with INR > 2.0, thrombocytopenia with platelet counts < 50,000
- The subject is pregnant or planning a pregnancy during the study period
- History of esophageal or gastric surgery other than Endoscopic Mucosal Resection (EMR)
- Patients who have undergone endoscopic ablative therapies
- Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
- Study patients with inadequate WATS3D specimens will not undergo a repeat brush biopsy test and will be excluded from the study
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- BE length < 1 cm or > 10 cm
- Patients within six weeks of receiving targeted forceps biopsies and/or EMR
- Patients with visible mucosal abnormality at the time of the WATS3D and random biopsy testing
- Patients with visible lesions that are either submucosal or covered with a clinically intact epithelium
Trial locations and contacts
1 site in 1 country.
About this study
This is a multi-center, prospective, randomized study which will enroll patients undergoing endoscopic surveillance due to a history of histologically confirmed dysplasia. A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study.
- Being tested
- Diagnostic Test
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic TestProcedure or surgery
WATS3D brush biopsy
| Study group | Role | What they receive |
|---|---|---|
| Barrett's associated esophageal dysplasia | Not described Receives: Procedure: Diagnostic Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of Barrett's associated high grade esophageal dysplasia and esophageal adenocarcinoma (HGD/EAC) using WATS3D and random 4 quadrant forceps biopsies taken at 2 cm intervals.
Measured: up to 2 years
Secondary outcomes (1)
Number of participants with Barrett's related dysplasia and adenocarcinoma diagnosed with random forceps biopsies and WATS3D biopsies used in alternating fashion.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start27 Sep 2017
- Primary completion18 Feb 2019
- Study completion18 Feb 2019
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.
- 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
- Cross-sectional
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- CDx Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raf Bisschops, MD, Principal investigator, University Hospitals Leuven, Dept. of GastroenterologyCesare Hassan, MD, Principal investigator, Nuovo Regina Margherita Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015389
- Sponsor's protocol ID
- CDx 810
- Status last verified
- Jul 2020
- First submitted
- 5 Jan 2017
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Tissue Analysis (WATS3D) For the Detection of High Grade Esophageal Dysplasia and Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03015389
- Acronym / sponsor ID
- CDx 810
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- CDx DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- 18 Feb 2019 (actual)
- Study completion
- 18 Feb 2019 (actual)
- First posted
- 10 Jan 2017 (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.
This is a multi-center, prospective, randomized study which will enroll patients undergoing endoscopic surveillance due to a history of histologically confirmed dysplasia. A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Barrett's associated esophageal dysplasia | – | Procedure: Diagnostic Test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Barrett's associated esophageal dysplasia
Key inclusion criteria (5 listed)
- Patients age: ≥ 18 years
- Patients should have a history of Barrett's associated esophageal dysplasia (either low or high-grade) confirmed on histology
- Willingness to undergo both WATS3D and random forceps biopsies while undergoing conventional EGD with sedation
- Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation
- Only patients who no visible mucosal abnormalities at the time that they undergo both random forceps biopsies and WATS3D testing of the esophagus will be included in this study
Key exclusion criteria (10 listed)
- Coagulopathy with INR > 2.0, thrombocytopenia with platelet counts < 50,000
- The subject is pregnant or planning a pregnancy during the study period
- History of esophageal or gastric surgery other than Endoscopic Mucosal Resection (EMR)
- Patients who have undergone endoscopic ablative therapies
- Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
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 |
|---|---|---|
| Diagnostic TestWATS3D brush biopsy | Procedure or surgery | Barrett's associated esophageal dysplasia |
Primary outcome
Detection rate of Barrett's associated high grade esophageal dysplasia and esophageal adenocarcinoma (HGD/EAC) using WATS3D and random 4 quadrant forceps biopsies taken at 2 cm intervals.
Time frame: up to 2 years
1 secondary outcome
Number of participants with Barrett's related dysplasia and adenocarcinoma diagnosed with random forceps biopsies and WATS3D biopsies used in alternating fashion.
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
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Barrett Esophagus
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.
Raf Bisschops, MD principal investigator
University Hospitals Leuven, Dept. of Gastroenterology
Cesare Hassan, MD principal investigator
Nuovo Regina Margherita 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 Esophageal Dysplasia, run by CDx Diagnostics at 1 site in Belgium.
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 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: finished, as of the sponsor's last update on 23 Jul 2020. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Detection rate of Barrett's associated high grade esophageal dysplasia and esophageal adenocarcinoma (HGD/EAC) using WATS3D and random 4 quadrant forceps biopsies taken at 2 cm intervals. (time frame: up to 2 years). 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 23 Jul 2020.