Katy O. and Paul M. Rady Esophageal and Gastric Center of Excellence

EnteroTracker (22-0320) Sponsor: EnteroTrack LLC — Pilot Study to Evaluate Utility of EnteroTracker® as a Minimally Invasive Sampling Method to Screen for Barrett’s Esophagus and Esophageal Cancer.

If you choose to enroll in this study: You will have the Enterotracker device administered. This device consists of swallowing a small capsule connected to a string. After a 60 min dwell time, the string will be removed and processed for critical biomarkers in diagnosing Barrett’s esophagus and esophageal cancers.

Goal: Evaluate the ability and tolerability of the EnteroTracker® to capture esophageal mucosal samples in adults with Barrett’s Esophageal and/or Esophageal Adenocarcinoma as well as controls. In the future, our hope is that this device could be used as an adjunct to your Barrett’s esophagus and esophageal cancer treatment.

Criteria to participate: 45 and older with a previous diagnosis of Barrett’s esophagus and/or esophageal adenocarcinoma without any previous endoscopic eradication therapy, esophageal surgery, history of a stricture, or swallowing disorders.

Type of Study: Treatment – Pilot

Visit clinicaltrials.gov to learn more about Enterotracker

Watch: A quick demo on what to expect if you choose to participate. https://enterotrack.com/

If you are interested in this study, please reach out to the any of the emails below:

jazmyne.gallegos@cuanschutz.edu

case.brennan@cuanschutz.edu

SWAT-BE (18-2431) Sponsor: CDx Diagnostics - A multi-center, randomized, blinded, superiority trial comparing the Seattle Biopsy Protocol vs WATS3D in patients with BE.

If you choose to enroll in this study, you will be placed into one of two groups:

Group 1: Seattle Biopsy protocol first, followed by the WATS3D brush

Group 2: WATS3D brush first, followed by the Seattle Biopsy protocol

Goal: To compare the diagnostic yield of neoplasia (Low Grade Dysplasia/High Grade Dysplasia/EAC) between the two techniques in the surveillance population and diagnostic yield of intestinal metaplasia between the two techniques in the screen population.

Criteria to participate: Patients over 45 with a diagnosis of Non-dysplastic Barrett’s esophagus without any prior endoscopic eradication therapy.

Type of Study: Treatment - Randomized

Visit clinicaltrials.gov to learn more about SWAT-BE

If you are interested in this study, please reach out to the any of the emails below:

jazmyne.gallegos@cuanschutz.edu

case.brennan@cuanschutz.edu

SURVENT (21-4972) Sponsor: NIDDK, NIH - A multi-center, randomized, controlled trial of SURVeillance vs. Endoscopic Therapy for Barrett’s esophagus Low Grade Dysplasia.

If you choose to enroll in this study, you will be placed into one of two groups:

Group 1: Endoscopic surveillance: EGD every 6 months in which biopsies will be obtain to manage the possible progression of your Low-Grade Dysplasia.

Group 2: Endoscopic Eradication Therapy: You will be seen every 3 -4 months for radiofrequency ablation of your Low-Grade Dysplasia until there is no more Barrett’s esophagus.

Goal: To compare the effectiveness of endoscopic surveillance and endoscopic eradication therapy for the management of Barrett’s esophagus and Low-Grade Dysplasia.

Criteria to participate: Any patient with a diagnosed with Low Grade Dysplasia Barrett’s esophagus in the last 12 months without any prior endoscopic eradication therapy.

Type of Study: Treatment – Randomized

Visit: https://www.barretts-survent.com/ and/or clinicaltrials.gov to learn more about SURVENT

If you are interested in this study, please reach out to the any of the emails below:

jazmyne.gallegos@cuanschutz.edu

case.brennan@cuanschutz.edu

(TREAT-BE) (14-2371) Sponsor: CU

If you choose to enroll in this study, your past and future Endoscopy findings will be included in our database.

Goal: To provide useful data of patients with BE and EAC undergoing Endoscopic Eradication Therapy in effort to improve overall patient outcomes.

Criteria to participate: Any patient with a diagnosis of Barrett’s esophagus referred for Endoscopic Eradication Therapy at University of Colorado Anschutz.

Type of Study: Longitudinal follow – up

Visit clinicaltrials.gov to learn more about Treat-BE

If you are interested in this study, please reach out to the any of the emails below:

jazmyne.gallegos@cuanschutz.edu

case.brennan@cuanschutz.edu

Biobank (16-2636) Sponsor: DOM-OESP, Paul O’Hara Endowed Chair Seed Award

If you choose to enroll in this study, we will include some of the tissue samples obtained during procedure in our Biorepository.

Goal: To develop a biobank containing biological specimens from patients with Barrett’s Esophagus and Esophageal Cancer.

Criteria to participate: Any patient with GERD, Barrett’s esophagus, or esophageal adenocarcinoma scheduled for an EGD procedure at University of Colorado Anschutz without any prior endoscopic eradication therapy.

Type of Study: Longitudinal – Biorepository

If you are interested in this study, please reach out to the any of the emails below:

jazmyne.gallegos@cuanschutz.edu

case.brennan@cuanschutz.edu

Post EET WATS3D (21-4145) Sponsor: CDx diagnostics – A multi-center prospective randomized controlled study to assess the additive diagnostic yield of WATS-3D sampling beyond that of Intestinal Metaplasia or dysplasia (recurrence) in patients who have undergone endoscopic eradication therapy for BE-reared neoplasia.

If you choose to enroll, you will be placed into one of two groups:

Group 1: Seattle Biopsy protocol first, followed by the WATS3D brush

Group 2: WATS3D brush first, followed by the Seattle Biopsy protocol

Goal: To determine whether the WATS-3D sampling is superior to the standard Seattle biopsy protocol in detecting recurrence of Barrett’s esophagus in patients who have achieved complete eradication of intestinal metaplasia post endoscopic eradication therapy.

Criteria to participate: Patients who have achieved complete eradication of intestinal metaplasia following endoscopic eradication therapy in the past 12 months.

Type of Study: Treatment - Randomized

Visit clinicaltrials.gov to learn more about Post EET WATS3D 

If you are interested in this study, please reach out to the any of the emails below:

jazmyne.gallegos@cuanschutz.edu

case.brennan@cuanschutz.edu

LucidDx EG-CL-102 (20-0449) Sponsor: Lucid Diagnostics, Inc. - Using EsoGuard, a swallow able balloon device, on Samples Collected Using EsoCheck, versus EGD, for the Diagnosis of Barrett’s esophagus with and without Dysplasia, and for esophageal adenocarcinoma.

If you choose to enroll in this study, Dr. Wani will administer the Esoguard device before your endoscopy. This device will collect cells and biomarkers that help identify the diagnosis of Barrett’s esophagus or esophageal cancers.

Goal: To measure the sensitivities of EsoGuard-based diagnosis the different stages of Barrett’s Esophagus in order to asses EsoGuard’s ability to detect disease across the entire continuum of disease progression.

Criteria to participate: Males 50 and above scheduled for an egd with a diagnosis of Barrett’s esophagus and/or esophageal adenocarcinoma.

Type of Study: Treatment - device

Visit clinicaltrials.gov to learn more about Lucid

If you are interested in this study, please reach out to the any of the emails below:

jazmyne.gallegos@cuanschutz.edu

case.brennan@cuanschutz.edu