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Department of Medicine

Barrett’s Esophagus (BE) Research Studies

Currently Enrolling

Nitrous Oxide For Endoscopic Ablation of Refractory Barrett’s Esophagus (NO FEAR-BE)

Currently enrolling by invitation only

Purpose: To evaluate the safety and efficacy of the C2 CryoBalloon Focal Ablation System for the treatment of persistent dysplasia or intestinal metaplasia (IM) in the tubular esophagus after 3 or more radiofrequency ablations (RFA) for dysplastic BE, or <50% eradication of BE after 2 RFA treatments.
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor: PENTAX of America, Inc.

Visit clinicaltrials.gov to learn more about NO FEAR-BE

Advanced a/LCI Systems for Improved Clinical Utility: An Optical Coherence Tomography (OCT) Pilot Study (OCT Pilot)

Currently enrolling by invitation only

Purpose: To test a newly developed imaging device in human subjects to determine 1) whether adequate tissue contact can be attained to acquire high quality images, and 2) to identify if these images can discern whether the imaged tissue is squamous or Barrett’s Esophagus (BE) epithelium.
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor: National Cancer Institute (NCI)

Visit clinicaltrials.gov to learn more about OCT Pilot

Non-Endoscopic Surveillance for Barrett’s Esophagus (BE) Following Ablative Therapy

Currently enrolling by invitation only

Purpose: To determine if a new, minimally invasive sampling technique, the Cytosponge, is a well-tolerated and effective means to sample the lining of the esophagus (food tube) in patients who have previously received radiofrequency ablation for Barrett’s Esophagus (a change in the lining of the esophagus/food tube from acid reflux).
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor: National Institutes of Health (NIH)

Visit clinicaltrials.gov to learn more about  Non-Endoscopic Surveillance for BE Following Ablative Therapy

A Prospective Single Arm Multicenter Study Evaluating the Effects of Spray Cryotherapy in Patients with Persistent Local Esophageal Cancer

Currently enrolling by invitation only

Purpose: The primary objective of this registry is to study the effects of the trūFreeze® Spray Cryotherapy System in a population of subjects who have been diagnosed with persistent local esophageal cancer and who are not surgical candidates or have completed or declined systemic therapy.
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor: CSA Medical, Inc.CSA medical.jpg

Visit clinicaltrials.gov to learn more about trūFreeze® Esophageal Cancer

Genetic and Environmental Determinants of Barrett’s Esophagus (BE)

Currently enrolling by invitation only

Purpose: This is a multi-center study whose aim is to define the epidemiology and genetics of Barrett’s esophagus and adenocarcinoma.
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor: National Institute of Diabetes, Digestive, & Kidney Disease

Visit clinicaltrials.gov to learn more about Genetic and Environmental Determinants of BE

UNC Barrett’s Esophagus and Esophageal Cancer Biorepository (BEECAB)

Currently enrolling by invitation only

Purpose: To learn more about Barrett’s Esophagus and esophageal cancer by collecting data and samples (blood and tissue) for a biorepository.
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor: University of North Carolina

Visit clinicaltrials.gov to learn more about the BEECAB study

Closed to Enrollment

Coldplay 3: Multi-Center Clinical Study to Evaluate the Coldplay CryoBalloonTM Focal Ablation System for the Treatment of Patients with Previously-Untreated Dysplastic Barrett’s Epithelium

Enrollment closed

Purpose: To collect additional data on the efficacy and safety of the CryoBalloon System, specifically in the treatment of patients with previously untreated (treatment naïve) Barrett’s Esophagus.
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor: C2 Therapeutics

Visit clinicaltrials.gov to learn more about Coldplay 3

Clinicaltrials.gov

Assessment of a Minimally Invasive Esophageal Cytology Collection System in Patients with Barrett’s Esophagus or GERD Symptoms

Enrollment closed


Purpose: To determine if a new, minimally invasive sampling technique, the Cytosponge, is a well-tolerated and effective means to sample the lining of the esophagus (food tube) in patients who have gastroesophageal reflux disease (GERD) or Barrett’s Esophagus (a change in the lining of the esophagus/food tube from acid reflux which is when acid and other contents from your stomach irritate the lining of your esophagus/food tube).
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor: GI Solutions – Covidien

Visit clinicaltrials.gov to learn more about Assessment of a minimally invasive esophageal cytology collection system in patients with BE or GERD

Clinicaltrials.gov

International, Multicenter, Prospective, Post Market Registry Using a New Device for Endoscopic Resection of Early Neoplasia in Barrett’s Esophagus – The Captivator™ EMR Registry

Enrollment closed

Purpose: To determine whether aspirin safely reduces the risk of re-developing BE after successful treatment.
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor: University of Texas MD Anderson Cancer Center, NCI

Visit clinicaltrials.gov to learn more about the Captivator EMR Registry

Clinicaltrials.gov

trūFreeze™ Spray Cryotherapy Patient Registry

Enrollment closed

Purpose: The primary objective of this registry is to collect efficacy data related to the use of truFreeze® spray cryotherapy in the pulmonary and gastrointestinal settings.
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor: CSA Medical, Inc.CSA medical.jpg

Visit clinicaltrials.gov to learn more about the truFreezeTM spray Cryotherapy Patient Registry

Clinicaltrials.gov

Please contact us for more information regarding any of the above active CEDAS research studies:

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