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
NCT ID: NCT03417570
Last Updated: 2022-09-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
100 participants
INTERVENTIONAL
2017-12-22
2021-11-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Performance Characteristics of Capsule Endoscopy With PillCam UGI Capsule Compared to Standard Endoscopy
NCT03167970
Endoscopic Detection of Dysplasia in Barrett's Esophagus
NCT01694511
Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus
NCT00903136
High Definition White Light Endoscopy and Narrow Band Imaging for the Assessment of Barrett's Disease After Endoscopic Therapy
NCT01360801
The Efficacy and Patient Tolerance of Ultrathin Nasal Endoscopy to Detect Barrett's Oesophagus
NCT02498041
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1: EGD with cap first, followed by EGD without cap
-Participants in the first arm will undergo EGD with cap first, followed by EGD without cap in the same procedural period.
Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI)
-The second endoscopist will be blinded to the results of the initial exam.
Olympus Disposable Distal Attachment Cap
-The second endoscopist will be blinded to the results of the initial exam.
Arm 2: EGD without cap first, followed by EGD with cap
-Participants in the second arm will undergo EGD without cap first, followed by EGD with cap in the same procedural period.
Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI)
-The second endoscopist will be blinded to the results of the initial exam.
Olympus Disposable Distal Attachment Cap
-The second endoscopist will be blinded to the results of the initial exam.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI)
-The second endoscopist will be blinded to the results of the initial exam.
Olympus Disposable Distal Attachment Cap
-The second endoscopist will be blinded to the results of the initial exam.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* Prior endoscopic treatment for BE.
* Unable to tolerate sedation due to medical comorbidities.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Washington University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vladimir M Kushnir, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Washington University School of Medicine
St Louis, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201708210
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.