Barrett EsophagusNCT02988934
The WATS3D (Wide Area Transepithelial Sample Biopsy With 3-Dimensional Computer-Assisted Analysis) U.S. Registry
An observational study of Barrett Esophagus and Gastroesophageal Reflux, run by CDx Diagnostics at 1 site in United States.
Trial summary
The purpose of this study is to create a registry (collect data and keep it in a research database) to learn more about two methods of taking small tissue samples from your esophagus (the esophagus is the tube that carries food and liquid from your mouth to your stomach.). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Barrett Esophagus, Gastroesophageal Reflux, Esophageal Dysplasia
- How many people
- 3,173 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 7 Feb 2023
- How long will I take part?
- 10 Years
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: males and females
Who may be able to join
- English speaking
- Able to read, comprehend, and complete the consent form
- Aged 18 to 80, and,
- Meet one of the following:
- Patients with heartburn or regurgitation undergoing a screening EGD, who undergo WATS3D sampling and forceps biopsies for suspicion of BE, or
- Patients with known BE with or without dysplasia undergoing a surveillance EGD with WATS3D biopsies and forceps biopsies, or
- Patients who have undergone endoscopic eradication therapy(including, but not limited to endoscopic mucosal resection, endoscopic submucosal dissection, radiofrequency ablation and/orcryoablation/spray cryotherapy)who are undergoing surveillance EGD following the establishment of complete eradication of intestinal metaplasia (CEIM) with accompanying WATS3D sampling and forceps biopsies.
Who cannot join
- Patients meeting any of the following criteria will be excluded from this study:
- Patients who on their enrollment endoscopy have a visible highly suspicious lesion, such as a nodule or ulcer, (noted while undergoing endoscopy) that requires targeted biopsy will be excluded from the study.Patients requiring a targeted biopsy on follow-up endoscopies will be allowed to remain in the study.
- Patients who do not undergo both biopsy forceps and WATS3D biopsy of the esophagus on their initial evaluationfor routine care will be excluded from this study. Subsequent endoscopicevaluation may include forceps biopsies alone, WATS3D biopsies alone, or both forceps and WATS3D biopsies.
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
The purpose of this study is to create a registry (collect data and keep it in a research database) to learn more about two methods of taking small tissue samples from your esophagus (the esophagus is the tube that carries food and liquid from your mouth to your stomach.). The two methods of sampling are: 1) Using forceps that take biopsies (small tissue samples) from your esophagus, and 2) Using a brush that also takes biopsies from your esophagus.
By recording the results of all of your biopsies over many years, it may be possible to find out if the brush biopsy, forceps biopsy, or both can predict which patients with heartburn develop Barrett's esophagus, (an abnormality in the esophagus that may lead to cancer), and which patients with Barrett's esophagus develop precancer and cancer. The data from your biopsies will be used to determine the best way to diagnose esophageal disease.
You are being asked to participate in the study because you are receiving an upper endoscopy (a procedure where a tube with a light and camera are inserted in your mouth and down your throat) with forceps and brush biopsies of your esophagus as part of your standard clinical care, and you are between the ages of 18 and 80.
- Medical subject headings
- Barrett Esophagus, Gastroesophageal Reflux, Esophageal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental yield for dysplasia due to WATS sampling above that noted from routine forceps biopsies in various clinical settings.
Measured: 10 years
Secondary outcomes (1)
Outcomes of patients undergoing WATS sampling.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startApr 2016
- Primary completion7 Feb 2023
- Study completion7 Feb 2023
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
- Prospective
- Enrolment
- 3,173 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- CDx Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988934
- Sponsor's protocol ID
- CDx 707
- Status last verified
- Feb 2023
- First submitted
- 29 Nov 2016
- Last updated
- 8 Feb 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The WATS3D (Wide Area Transepithelial Sample Biopsy With 3-Dimensional Computer-Assisted Analysis) U.S. Registry
- ClinicalTrials.gov ID
- NCT02988934
- Acronym / sponsor ID
- CDx 707
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 3,173 participants (actual)
- Lead sponsor
- CDx DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- Apr 2016
- Primary completion
- 7 Feb 2023 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 12 Dec 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 purpose of this study is to create a registry (collect data and keep it in a research database) to learn more about two methods of taking small tissue samples from your esophagus (the esophagus is the tube that carries food and liquid from your mouth to your stomach.). The two methods of sampling are: 1) Using forceps that take biopsies (small tissue samples) from your esophagus, and 2) Using a brush that also takes biopsies from your esophagus.
By recording the results of all of your biopsies over many years, it may be possible to find out if the brush biopsy, forceps biopsy, or both can predict which patients with heartburn develop Barrett's esophagus, (an abnormality in the esophagus that may lead to cancer), and which patients with Barrett's esophagus develop precancer and cancer. The data from your biopsies will be used to determine the best way to diagnose esophageal disease.
You are being asked to participate in the study because you are receiving an upper endoscopy (a procedure where a tube with a light and camera are inserted in your mouth and down your throat) with forceps and brush biopsies of your esophagus as part of your standard clinical care, and you are between the ages of 18 and 80.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- males and females
Key inclusion criteria (7 listed)
- English speaking
- Able to read, comprehend, and complete the consent form
- Aged 18 to 80, and,
- Meet one of the following:
- Patients with heartburn or regurgitation undergoing a screening EGD, who undergo WATS3D sampling and forceps biopsies for suspicion of BE, or
Key exclusion criteria (3 listed)
- Patients meeting any of the following criteria will be excluded from this study:
- Patients who on their enrollment endoscopy have a visible highly suspicious lesion, such as a nodule or ulcer, (noted while undergoing endoscopy) that requires targeted biopsy will be excluded from the study.Patients requiring a targeted biopsy on follow-up endoscopies will be allowed to remain in the study.
- Patients who do not undergo both biopsy forceps and WATS3D biopsy of the esophagus on their initial evaluationfor routine care will be excluded from this study. Subsequent endoscopicevaluation may include forceps biopsies alone, WATS3D biopsies alone, or both forceps and WATS3D biopsies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incremental yield for dysplasia due to WATS sampling above that noted from routine forceps biopsies in various clinical settings.
Time frame: 10 years
1 secondary outcome
Outcomes of patients undergoing WATS sampling.
Time frame: 10 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
Related trials for Barrett Esophagus
RecruitingObservational study
"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
Barrett Esophagus, Barrett Esophagus Adenocarcinoma
Not yet recruitingObservational study
Lucid BE Biomarkers Study
Barrett's Esophagus, Barrett's Esophagus With Dysplasia
RecruitingObservational study
Impact of RFA on Esophageal Distensibility and Mucosal Impedance
Dysplastic Barrett's Esophagus, Radiofrequency Ablation
Active, not recruitingObservational study
Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Barrett Esophagus, Barretts Esophagus With Dysplasia
Active, not recruiting
Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
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.
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 Gastroesophageal Reflux, 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 7 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: stopped early, as of the sponsor's last update on 8 Feb 2023. 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 was stopped early. 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?
Incremental yield for dysplasia due to WATS sampling above that noted from routine forceps biopsies in various clinical settings. (time frame: 10 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 8 Feb 2023.