Barrett EsophagusNCT03008980
WATS3D for the Detection of Esophageal Dysplasia
An observational study of Barrett Esophagus and Esophageal Dysplasia, run by CDx Diagnostics at 1 site in United States.
Trial summary
Patients will be recruited from participating institutions prior to planned routine care EGD with WATS3D brush samples and forceps biopsies. Eligibility will be reviewed and patients who are potentially eligible for the study will be approached regarding the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus, Esophageal Dysplasia, Esophagus Adenocarcinoma
- What is being tested?
- Diagnostic Test
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2018
- 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: Patients with known Barrett's Esophagus.
Who may be able to join
- Patients age: ≥ 18 years
- Patients should have a history of Barrett's esophagus (with or without dysplasia of either indefinite, low grade or high-grade)
- Willingness to undergo both WATS and 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 undergo both forceps biopsies and WATS of the esophagus will be included in this study
Who cannot join
- Coagulopathy with an international normalized ratio above 2.0;
- Thrombocytopenia with platelet counts below 50,000
- History of prior esophageal ablation therapies, esophageal or gastric surgery
- Unresolved drug or alcohol dependency
- Pregnancy or planned pregnancy during the study period
- Patients found to have a BE length less than 1 cm or greater than 10 cm
- Patients with any visible lesions greater than 10 mm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Analysis (WATS) for the Detection of Esophageal Dysplasia: A Prospective, Randomized, Tandem Study
Patients will be recruited from participating institutions prior to planned routine care EGD with WATS3D brush samples and forceps biopsies. Eligibility will be reviewed and patients who are potentially eligible for the study will be approached regarding the study. If interested, participants will be consented and proceed with routine care EGD. The study coordinator or other research personnel will document information from the routine care endoscopy as part of this research study. Follow-up information collected will include WATS3D cytology and forceps biopsy pathology results from any routine care endoscopy performed during the course of participation in the study, any surgeries received and related to their condition, and any other care received as part of their condition. WATS3D samples will be sent to CDx Diagnostics for analysis.
- 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 TestOther
| Study group | Role | What they receive |
|---|---|---|
| Community GI Group | Diagnostic Test Receives: Other: Diagnostic Test | |
| Academic GI Group | Diagnostic Test Receives: Other: Diagnostic Test | |
| Academic Esophageal Dysplasia and Cancer | Diagnostic Test Receives: Other: Diagnostic Test | |
| Community Barrett's Esophagus Screening | Diagnostic Test Receives: Other: Diagnostic Test | |
| Community Esophageal Dysplasia | Diagnostic Test Receives: Other: Diagnostic Test | |
| Post-Ablation BE and Esophagus Dysplasia | Diagnostic Test Receives: Other: Diagnostic Test | |
| GERD, BE, and Esophageal Dysplasia | Diagnostic Test Receives: Other: Diagnostic Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcomes of patients undergoing WATS sampling. Specifically incremental yield for Barrett's Esophagus and Esophageal Dysplasia due to WATS sampling above that noted from routine forceps biopsies in various clinical settings.
Measured: up to 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startMay 2014
- Primary completionJan 2015
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- CDx Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rockford Gastroenterology Associates, Icahn School of Medicine at Mount Sinai, Temple University, University of Rochester, University of Kansas Medical Center, NYU Langone Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008980
- Sponsor's protocol ID
- CDx 103
- Status last verified
- Oct 2021
- First submitted
- 23 Dec 2016
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Vennalaganti PR, Kaul V, Wang KK, Falk GW, Shaheen NJ, Infantolino A, Johnson DA, Eisen G, Gerson LB, Smith MS, Iyer PG, Lightdale CJ, Schnoll-Sussman F, Gupta N, Gross SA, Abrams J, Haber GB, Chuttani R, Pleskow DK, Kothari S, Goldblum JR, Zhang Y, Sharma P. Increased detection of Barrett's esophagus-associated neoplasia using wide-area trans-epithelial sampling: a multicenter, prospective, randomized trial. Gastrointest Endosc. 2018 Feb;87(2):348-355. doi: 10.1016/j.gie.2017.07.039. Epub 2017 Jul 27.
PubMed 28757316
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. 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 Analysis (WATS) for the Detection of Esophageal Dysplasia: A Prospective, Randomized, Tandem Study
- ClinicalTrials.gov ID
- NCT03008980
- Acronym / sponsor ID
- CDx 103
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- CDx DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Rockford Gastroenterology Associates, Icahn School of Medicine at Mount Sinai, Temple University, University of Rochester, University of Kansas Medical Center, NYU Langone Health
- Study start
- May 2014 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 4 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.
Patients will be recruited from participating institutions prior to planned routine care EGD with WATS3D brush samples and forceps biopsies. Eligibility will be reviewed and patients who are potentially eligible for the study will be approached regarding the study. If interested, participants will be consented and proceed with routine care EGD. The study coordinator or other research personnel will document information from the routine care endoscopy as part of this research study. Follow-up information collected will include WATS3D cytology and forceps biopsy pathology results from any routine care endoscopy performed during the course of participation in the study, any surgeries received and related to their condition, and any other care received as part of their condition. WATS3D samples will be sent to CDx Diagnostics for analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Community GI Group | – | Other: Diagnostic TestDiagnostic Test |
| Academic GI Group | – | Other: Diagnostic TestDiagnostic Test |
| Academic Esophageal Dysplasia and Cancer | – | Other: Diagnostic TestDiagnostic Test |
| Community Barrett's Esophagus Screening | – | Other: Diagnostic TestDiagnostic Test |
| Community Esophageal Dysplasia | – | Other: Diagnostic TestDiagnostic Test |
| Post-Ablation BE and Esophagus Dysplasia | – | Other: Diagnostic TestDiagnostic Test |
| GERD, BE, and Esophageal Dysplasia | – | Other: Diagnostic TestDiagnostic Test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known Barrett's Esophagus.
Key inclusion criteria (5 listed)
- Patients age: ≥ 18 years
- Patients should have a history of Barrett's esophagus (with or without dysplasia of either indefinite, low grade or high-grade)
- Willingness to undergo both WATS and 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 undergo both forceps biopsies and WATS of the esophagus will be included in this study
Key exclusion criteria (7 listed)
- Coagulopathy with an international normalized ratio above 2.0;
- Thrombocytopenia with platelet counts below 50,000
- History of prior esophageal ablation therapies, esophageal or gastric surgery
- Unresolved drug or alcohol dependency
- Pregnancy or planned pregnancy during the study period
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 Test | Other | Academic Esophageal Dysplasia and Cancer, Academic GI Group, Community Barrett's Esophagus Screening, Community Esophageal Dysplasia, Community GI Group, GERD, BE, and Esophageal Dysplasia, Post-Ablation BE and Esophagus Dysplasia |
Primary outcome
Outcomes of patients undergoing WATS sampling. Specifically incremental yield for Barrett's Esophagus and Esophageal Dysplasia due to WATS sampling above that noted from routine forceps biopsies in various clinical settings.
Time frame: up to 18 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 4 Nov 2021.
- Derived from this study: PubMed 28757316Vennalaganti PR, Kaul V, Wang KK, Falk GW, Shaheen NJ, Infantolino A, Johnson DA, Eisen G, Gerson LB, Smith MS, Iyer PG, Lightdale CJ, Schnoll-Sussman F, Gupta N, Gross SA, Abrams J, Haber GB, Chuttani R, Pleskow DK, Kothari S, Goldblum JR, Zhang Y, Sharma P. Increased detection of Barrett's esophagus-associated neoplasia using wide-area trans-epithelial sampling: a multicenter, prospective, randomized trial. Gastrointest Endosc. 2018 Feb;87(2):348-355. doi: 10.1016/j.gie.2017.07.039. Epub 2017 Jul 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 5 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: finished, as of the sponsor's last update on 4 Nov 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?
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?
Outcomes of patients undergoing WATS sampling. Specifically incremental yield for Barrett's Esophagus and Esophageal Dysplasia due to WATS sampling above that noted from routine forceps biopsies in various clinical settings. (time frame: up to 18 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03008980, which also lists 1 linked publication.
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 Nov 2021.