Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
125 participants
OBSERVATIONAL
2007-07-31
2013-12-31
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.
Barrett's Esophagus in Patients with GERD
NCT06897540
Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus
NCT00573911
Quality of Life in Barrett's Esophagus and Gastro-Esophageal Reflux Disease
NCT01572974
Acetic Acid for the Detection of Esophageal Neoplasms
NCT04054713
Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique
NCT03621319
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The protocol at The Valley Hospital and Blumenthal Cancer Center aims to standardize the management of patients with Barrett's esophagus, with and without dysplasia, using evidence-based, cutting edge diagnostic and therapeutic algorithms and techniques such as radiofrequency ablation, endoscopic mucosal resection, and surveillance endoscopy with biopsies. If biopsies suggest the development of carcinoma or high grade dysplasia surgical removal of the esophagus is recommended. This study aims to look at the long-term efficacy of these procedures. In addition, data regarding clinical outcomes will be collected as well as blood, tissue and surgical specimens for proteomic analysis in hopes of identifying biomarkers associated with the progression of dysplasia to adenocarcinoma. Although patients will ultimately make their own informed decisions regarding the management of their BE, this protocol serves to unify physician recommendations, and allows for the collection and interpretation of data.
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.
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Algorithm #1
Patients without visable lesions
Endoscopy
Initial Assessment for lesions can be based on information obtained from previous upper endoscopies and or pathology reports. Repeat Endoscopic assessments are based on initial and follow-up assessments.
Algorithm #2
Patients with a visable lesion that is less than 1cm
Endoscopy
Initial Assessment for lesions can be based on information obtained from previous upper endoscopies and or pathology reports. Repeat Endoscopic assessments are based on initial and follow-up assessments.
Radiofrequency ablation protocol
Ablation using the HALO 360 system according to protocol established by BARRX, Inc.
Endoscopic mucosal resection protocol
Excision of lesion using DUETTE, marketed by Wilson-Cook
Algorithm #3
Patients with a visable lesion greater than 1cm
Endoscopy
Initial Assessment for lesions can be based on information obtained from previous upper endoscopies and or pathology reports. Repeat Endoscopic assessments are based on initial and follow-up assessments.
Radiofrequency ablation protocol
Ablation using the HALO 360 system according to protocol established by BARRX, Inc.
Endoscopic mucosal resection protocol
Excision of lesion using DUETTE, marketed by Wilson-Cook
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Endoscopy
Initial Assessment for lesions can be based on information obtained from previous upper endoscopies and or pathology reports. Repeat Endoscopic assessments are based on initial and follow-up assessments.
Radiofrequency ablation protocol
Ablation using the HALO 360 system according to protocol established by BARRX, Inc.
Endoscopic mucosal resection protocol
Excision of lesion using DUETTE, marketed by Wilson-Cook
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient must have Barrett's Esophagus. Patients may be enrolled based on previous endoscopy reports and/or pathology reports. It is not necessary that each patient have endoscopy for the sole purpose of enrollment.
* Must agree to allow their clinical information to be collected, stored, analyzed and reported.
* Must allow portions of their biopsy/surgical specimens to be collected, stored, analyzed and reported.
* Must agree to fill out patient questionnaires in conjunction with the research study assistant assigned to this protocol (either in person or via telephone contact) at designated timepoints.
Exclusion Criteria
* Unable to provide informed consent.
* Unable or unwilling to undergo endoscopic procedures.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Valley Health System
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.
Robert J. Korst, MD
Role: PRINCIPAL_INVESTIGATOR
Valley Health Systems/ The Valley Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Valley Health System - The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VHS07.0017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.