GERDNCT03859557
The Evaluation of Patients With Esophageal and Foregut Disorders With WATS (Wide Area Transepithelial Sample With 3-Dimensional Computer-Assisted Analysis) vs. 4-Quadrant Forceps Biopsy
An observational study of GERD and Barrett Esophagus, run by CDx Diagnostics at 1 site in United States.
Trial summary
Patients scheduled to undergo routine upper endoscopy for foregut or esophageal symptoms or undergoing surveillance for Barrett's esophagus with no dysplasia or low-grade dysplasia are candidates for participation, but patients with known high-grade dysplasia or adenocarcinoma or with a history of prior endoscopic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD, Barrett Esophagus, Low Grade Esophageal Glandular Dysplasia
- How many people
- 1,032 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 31 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: Eligible patients are those who undergo routine upper endoscopy while under sedation to evaluate foregut or esophageal symptoms.
Who may be able to join
- Both males and females at least 18 years of age undergoing routine upper endoscopy to evaluate symptoms of esophageal or foregut disorders (reflux disease, BE, esophageal strictures, swallowing disorders, dyspepsia, hiatal hernias, motility issues, gastric issues).
- Institutional Review Board (IRB)-approved consent must be signed by patients prior to participating in this study.
Who cannot join
- Patients who do not undergo either FB or WATS biopsy
- Patients with inadequate WATS or FB specimens
- Known history of high-grade dysplasia or adenocarcinoma
- Prior history of endoscopic resection or ablation for Barrett's with high-grade dysplasia or adenocarcinoma
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Portland Medical Center
Portland, Oregon, 97213
About this study
Patients scheduled to undergo routine upper endoscopy for foregut or esophageal symptoms or undergoing surveillance for Barrett's esophagus with no dysplasia or low-grade dysplasia are candidates for participation, but patients with known high-grade dysplasia or adenocarcinoma or with a history of prior endoscopic resection or ablation for these conditions are not candidates for participation.
At endoscopy, all patients will be initially assessed for the presence of an endoscopic suspicious lesion using white light and if appropriate narrow band imaging or similar enhanced imaging techniques. All suspicious lesions undergo targeted biopsy first, and then either 4-Quadrant Random Forceps Biopsy or WATS biopsies of the GEJ and if present the columnar-lined esophagus based on the assigned randomization away from the area of targeted biopsies. A biopsy will be obtained from the antrum in each patient to assess for H. pylori infection and the presence of intestinal metaplasia.
Read the detailed description
Patients scheduled to undergo routine upper endoscopy for foregut or esophageal symptoms will be enrolled. Patients undergoing surveillance for Barrett's esophagus with no dysplasia or low-grade dysplasia are candidates for participation, but patients with known high-grade dysplasia or adenocarcinoma or with a history of prior endoscopic resection or ablation for these conditions are not candidates for participation. Informed consent will be obtained from every patient prior to enrollment.
Patients will be randomized prior to starting the procedure. Each patient will receive a randomization code at the time of randomization. It is important that the randomization code be included in the Case Report Form submitted with each patient, and will represent the unique deidentified code for each patient's data for inclusion in the study database.
At endoscopy, all patients will be initially assessed for the presence of an endoscopic suspicious lesion using white light and if appropriate narrow band imaging or similar enhanced imaging techniques. All suspicious lesions undergo targeted biopsy first, and then either 4-Quadrant Random Forceps Biopsy or WATS biopsies of the GEJ and if present the columnar-lined esophagus based on the assigned randomization away from the area of targeted biopsies. A biopsy will be obtained from the antrum in each patient to assess for H. pylori infection and the presence of intestinal metaplasia.
Targeted forceps biopsies of any endoscopic suspicious area will be placed in a separate pathology bottle from those obtained from 4-Quadrant Random Forceps Biopsy and analyzed separately as well.
All the components needed to perform WATS biopsies are included in a kit with complete written instructions.
WATS specimens will be analyzed by CDx Diagnostics. Investigator will ship the WATS specimens to CDx Diagnostics in accordance with CDx's instructions. Forceps biopsies will be analyzed by institution's pathology department and the pathology department of each additional site participating in the Study per standard protocol.
The Investigator will determine appropriate follow-up of patients with and without IM or dysplasia detected by WATS or FB per standard individual and / or institution protocol.
Investigator and all investigators at the additional sites will supply the study coordinator with de-identified data for each specimen, such de-identified data including patient demographics, endoscopic findings, and results of the FB of GEJ, antrum plus / minus esophagus. Study Data will be maintained on a secure database by the study coordinator during the Term and for six years thereafter.
Biopsies with intestinal metaplasia or dysplasia may be reviewed by a central pathologist to confirm the original pathologic interpretation when there is a discrepancy between WATS and FB that is greater than 10%.
- Medical subject headings
- Gastroesophageal Reflux, Barrett Esophagus, Esophageal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 4-Quadrant Random Forceps Biopsy | Random sampling within a quadrant of esophageal tissue using forceps. | |
| WATS biopsies | Wide area transepithelial sampling with computer aided pathologic interpretation of tissue. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yield of WATS biopsies compared to Forceps biopsies
Intestinal metaplasia is a premalignant change in the normal epithelium lining the esophagus and gastroesophageal junction. It is evaluated on tissue samples from these areas by a pathologist under a microscope, who then determines if intestinal metaplasia is present or not. All specimens retrieved by upper endoscopy, whether by standard biopsy or by WATS, will be examined by a pathologist. The pathology reports will be reviewed and the frequency that intestinal metaplasia is found by standard biopsy vs WATS will be statistically compared.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start1 Oct 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 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 GERDStudies 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
- Enrolment
- 1,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- CDx Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Foundation for Surgical Innovation and Education
- Responsible party
- Principal investigator, Steven DeMeester, The Oregon Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859557
- Sponsor's protocol ID
- CDx 810b
- Status last verified
- Feb 2019
- First submitted
- 15 Feb 2019
- Last updated
- 1 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
DeMeester S, Smith C, Severson P, Loveitt A, Jobe B, Woodworth P, Wilcox D, Dunst C; Hawaii Esophageal Course Study Group. Multicenter randomized controlled trial comparing forceps biopsy sampling with wide-area transepithelial sampling brush for detecting intestinal metaplasia and dysplasia during routine upper endoscopy. Gastrointest Endosc. 2022 Jun;95(6):1101-1110.e2. doi: 10.1016/j.gie.2021.11.044. Epub 2021 Dec 10.
PubMed 34902373
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Patients With Esophageal and Foregut Disorders With WATS (Wide Area Transepithelial Sample With 3-Dimensional Computer-Assisted Analysis) vs. 4-Quadrant Forceps Biopsy
- ClinicalTrials.gov ID
- NCT03859557
- Acronym / sponsor ID
- CDx 810b
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,032 participants (actual)
- Lead sponsor
- CDx DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Foundation for Surgical Innovation and Education
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 1 Mar 2019 (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.
Patients scheduled to undergo routine upper endoscopy for foregut or esophageal symptoms or undergoing surveillance for Barrett's esophagus with no dysplasia or low-grade dysplasia are candidates for participation, but patients with known high-grade dysplasia or adenocarcinoma or with a history of prior endoscopic resection or ablation for these conditions are not candidates for participation.
At endoscopy, all patients will be initially assessed for the presence of an endoscopic suspicious lesion using white light and if appropriate narrow band imaging or similar enhanced imaging techniques. All suspicious lesions undergo targeted biopsy first, and then either 4-Quadrant Random Forceps Biopsy or WATS biopsies of the GEJ and if present the columnar-lined esophagus based on the assigned randomization away from the area of targeted biopsies. A biopsy will be obtained from the antrum in each patient to assess for H. pylori infection and the presence of intestinal metaplasia.
Detailed description
Patients scheduled to undergo routine upper endoscopy for foregut or esophageal symptoms will be enrolled. Patients undergoing surveillance for Barrett's esophagus with no dysplasia or low-grade dysplasia are candidates for participation, but patients with known high-grade dysplasia or adenocarcinoma or with a history of prior endoscopic resection or ablation for these conditions are not candidates for participation. Informed consent will be obtained from every patient prior to enrollment.
Patients will be randomized prior to starting the procedure. Each patient will receive a randomization code at the time of randomization. It is important that the randomization code be included in the Case Report Form submitted with each patient, and will represent the unique deidentified code for each patient's data for inclusion in the study database.
At endoscopy, all patients will be initially assessed for the presence of an endoscopic suspicious lesion using white light and if appropriate narrow band imaging or similar enhanced imaging techniques. All suspicious lesions undergo targeted biopsy first, and then either 4-Quadrant Random Forceps Biopsy or WATS biopsies of the GEJ and if present the columnar-lined esophagus based on the assigned randomization away from the area of targeted biopsies. A biopsy will be obtained from the antrum in each patient to assess for H. pylori infection and the presence of intestinal metaplasia.
Targeted forceps biopsies of any endoscopic suspicious area will be placed in a separate pathology bottle from those obtained from 4-Quadrant Random Forceps Biopsy and analyzed separately as well.
All the components needed to perform WATS biopsies are included in a kit with complete written instructions.
WATS specimens will be analyzed by CDx Diagnostics. Investigator will ship the WATS specimens to CDx Diagnostics in accordance with CDx's instructions. Forceps biopsies will be analyzed by institution's pathology department and the pathology department of each additional site participating in the Study per standard protocol.
The Investigator will determine appropriate follow-up of patients with and without IM or dysplasia detected by WATS or FB per standard individual and / or institution protocol.
Investigator and all investigators at the additional sites will supply the study coordinator with de-identified data for each specimen, such de-identified data including patient demographics, endoscopic findings, and results of the FB of GEJ, antrum plus / minus esophagus. Study Data will be maintained on a secure database by the study coordinator during the Term and for six years thereafter.
Biopsies with intestinal metaplasia or dysplasia may be reviewed by a central pathologist to confirm the original pathologic interpretation when there is a discrepancy between WATS and FB that is greater than 10%.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-Quadrant Random Forceps Biopsy | – | –Random sampling within a quadrant of esophageal tissue using forceps. |
| WATS biopsies | – | –Wide area transepithelial sampling with computer aided pathologic interpretation of tissue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients are those who undergo routine upper endoscopy while under sedation to evaluate foregut or esophageal symptoms.
Key inclusion criteria (2 listed)
- Both males and females at least 18 years of age undergoing routine upper endoscopy to evaluate symptoms of esophageal or foregut disorders (reflux disease, BE, esophageal strictures, swallowing disorders, dyspepsia, hiatal hernias, motility issues, gastric issues).
- Institutional Review Board (IRB)-approved consent must be signed by patients prior to participating in this study.
Key exclusion criteria (4 listed)
- Patients who do not undergo either FB or WATS biopsy
- Patients with inadequate WATS or FB specimens
- Known history of high-grade dysplasia or adenocarcinoma
- Prior history of endoscopic resection or ablation for Barrett's with high-grade dysplasia or adenocarcinoma
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
Yield of WATS biopsies compared to Forceps biopsies
Time frame: 12 months
Intestinal metaplasia is a premalignant change in the normal epithelium lining the esophagus and gastroesophageal junction. It is evaluated on tissue samples from these areas by a pathologist under a microscope, who then determines if intestinal metaplasia is present or not. All specimens retrieved by upper endoscopy, whether by standard biopsy or by WATS, will be examined by a pathologist. The pathology reports will be reviewed and the frequency that intestinal metaplasia is found by standard biopsy vs WATS will be statistically compared.
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 1 Mar 2019.
- Derived from this study: PubMed 34902373DeMeester S, Smith C, Severson P, Loveitt A, Jobe B, Woodworth P, Wilcox D, Dunst C; Hawaii Esophageal Course Study Group. Multicenter randomized controlled trial comparing forceps biopsy sampling with wide-area transepithelial sampling brush for detecting intestinal metaplasia and dysplasia during routine upper endoscopy. Gastrointest Endosc. 2022 Jun;95(6):1101-1110.e2. doi: 10.1016/j.gie.2021.11.044. Epub 2021 Dec 10.
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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 GERD and Barrett Esophagus, 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 2 inclusion and 4 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 1 Mar 2019. 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?
Yield of WATS biopsies compared to Forceps biopsies (time frame: 12 months). 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 NCT03859557, 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 1 Mar 2019.