Barrett EsophagusNCT03417570

Cap Assisted Upper Endoscopy Versus High Definition White Light Endoscopy and Narrow Band Imaging Alone In The Detection Of Visible Lesions Barrett's Esophagus: A Randomized Tandem Study

A study testing Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI) and Olympus Disposable Distal Attachment Cap in people with Barrett Esophagus, run by Washington University School of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The hypothesis is that the addition of a transparent cap to the end of the endoscope will increase the detection and diagnostic yield of visible lesions in Barrett's esophagus. Thus, the goal of this tandem design trial is to compare the diagnostic yield (DY) of cap assisted endoscopy with that of conventional… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Barrett Esophagus
What is being tested?: Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI) and Olympus Disposable Distal Attachment Cap
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 22 Dec 2017to 17 Nov 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Must be at least 18 years of age.
Must be patients undergoing standard of care EGD for the confirmation of dysplasia in BE or EET for dysplasia in BE.
Must be able to understand and willing to sign an IRB-approved written informed consent document.

Who cannot join

Pregnant or breastfeeding.
Prior endoscopic treatment for BE.
Unable to tolerate sedation due to medical comorbidities.

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Conditions: Barrett Esophagus
Being tested: Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI), Olympus Disposable Distal Attachment Cap
Medical subject headings: Barrett Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI)Procedure or surgery
Also called EGD
-The second endoscopist will be blinded to the results of the initial exam.
Olympus Disposable Distal Attachment CapDevice
Also called Cap
-The second endoscopist will be blinded to the results of the initial exam.

Study groups in NCT03417570
Study group	Role	What they receive
Arm 1: EGD with cap first, followed by EGD without cap	Experimental	-Participants in the first arm will undergo EGD with cap first, followed by EGD without cap in the same procedural period. Receives: Procedure: Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI); Device: Olympus Disposable Distal Attachment Cap
Arm 2: EGD without cap first, followed by EGD with cap	Experimental	-Participants in the second arm will undergo EGD without cap first, followed by EGD with cap in the same procedural period. Receives: Procedure: Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI); Device: Olympus Disposable Distal Attachment Cap

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Had a Diagnostic Yield Obtained
-Diagnostic yield is defined as Barrett's esophagus lesions that were identified and confirmed histologically as low grade dysplasia, high grade dysplasia, intramucosal cancer, or invasive adenocarcinoma
Measured: At the time of procedure (day 1)

Secondary outcomes (4)

Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap
Measured: At the time of procedure (day 1)
Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma
Measured: At the time of procedure (day 1)
Total Procedure Duration in Seconds
Measured: At the time of procedure (day 1)
Safety as Measured by Number of Participants With Procedure-related Adverse Events
- The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
- Adverse events were collected for the entire procedure as a whole and for 48 hours after the procedure and were not separately collected for each part of the procedure (EGD without CAP versus EGD with CAP).
Measured: Through 48 hours after EGD

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Dec 201717 Nov 2021

First posted31 Jan 2018
Study start22 Dec 2017
Primary completion15 Nov 2021
Study completion17 Nov 2021

Why it stopped: Futility

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Barrett EsophagusStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03417570
Sponsor's protocol ID: 201708210
Status last verified: Aug 2022
First submitted: 25 Jan 2018
Last updated: 1 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
Active, not recruiting
Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule
Barrett's Esophagus

All Barrett Esophagus trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cap Assisted Upper Endoscopy Versus High Definition White Light Endoscopy and Narrow Band Imaging Alone In The Detection Of Visible Lesions Barrett's Esophagus: A Randomized Tandem Study
ClinicalTrials.gov ID: NCT03417570
Acronym / sponsor ID: 201708210
Conditions: Barrett Esophagus
Study type: Interventional
Recruitment status: TerminatedReason stopped: Futility
Enrolment: 100 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: 22 Dec 2017 (actual)
Primary completion: 15 Nov 2021 (actual)
Study completion: 17 Nov 2021 (actual)
First posted: 31 Jan 2018 (actual)
Results: Posted 29 Jul 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1: EGD with cap first, followed by EGD without cap	Experimental	Procedure: Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI), Device: Olympus Disposable Distal Attachment Cap-Participants in the first arm will undergo EGD with cap first, followed by EGD without cap in the same procedural period.
Arm 2: EGD without cap first, followed by EGD with cap	Experimental	Procedure: Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI), Device: Olympus Disposable Distal Attachment Cap-Participants in the second arm will undergo EGD without cap first, followed by EGD with cap in the same procedural period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Must be at least 18 years of age.
Must be patients undergoing standard of care EGD for the confirmation of dysplasia in BE or EET for dysplasia in BE.
Must be able to understand and willing to sign an IRB-approved written informed consent document.

Key exclusion criteria (3 listed)

Pregnant or breastfeeding.
Prior endoscopic treatment for BE.
Unable to tolerate sedation due to medical comorbidities.

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
Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI)Also: EGD-The second endoscopist will be blinded to the results of the initial exam.	Procedure or surgery	Arm 1: EGD with cap first, followed by EGD without cap, Arm 2: EGD without cap first, followed by EGD with cap
Olympus Disposable Distal Attachment CapAlso: Cap-The second endoscopist will be blinded to the results of the initial exam.	Device	Arm 1: EGD with cap first, followed by EGD without cap, Arm 2: EGD without cap first, followed by EGD with cap

Primary outcome

Number of Participants Who Had a Diagnostic Yield Obtained
Time frame: At the time of procedure (day 1)
-Diagnostic yield is defined as Barrett's esophagus lesions that were identified and confirmed histologically as low grade dysplasia, high grade dysplasia, intramucosal cancer, or invasive adenocarcinoma

4 secondary outcomes

Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap
Time frame: At the time of procedure (day 1)
Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma
Time frame: At the time of procedure (day 1)
Total Procedure Duration in Seconds
Time frame: At the time of procedure (day 1)
Safety as Measured by Number of Participants With Procedure-related Adverse Events
Time frame: Through 48 hours after EGD

Results and safety

Results posted to the registry on 29 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: EGD With Cap First, Followed by EGD Without Cap	50	50
Arm 2: EGD Without Cap First, Followed by EGD With Cap	50	50

Primary outcome: Number of Participants Who Had a Diagnostic Yield Obtained

Time frame: At the time of procedure (day 1). Count of participants. Unit: Participants

Measure	EGD Without CAP n = 56	EGD With CAP n = 60
Value	56	60

Population analysed: Participants had to have visible lesions to be evaluable for this outcome measure.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from start of EGD until 48 hours after EGD.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: EGD With Cap First, Followed by EGD Without Cap	0 of 50 (0%)	0 of 50 (0%)	0 of 50
Arm 2: EGD Without Cap First, Followed by EGD With Cap	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Barrett Esophagus

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
Active, not recruiting
Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule
Barrett's 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.

Vladimir M Kushnir, M.D. principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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 1 Sep 2022. 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?

Yes. Results are posted in the registry (first posted 29 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Who Had a Diagnostic Yield Obtained (time frame: At the time of procedure (day 1)). 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 NCT03417570.

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 Sep 2022.