Barrett's Esophagus (BE) Research Studies

CEDAS research studies that are currently enrolling participants with Barrett's Esophagus (BE).

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

Currently enrolling by invitation only

Cytosponge. Source: http://www.mrc-cu.cam.ac.uk/images/Sponge.jpg(Figure source: http://www.mrc-cu.cam.ac.uk/images/Sponge.jpg)

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


Prevalence of Dysplasia of the Gastric Cardia

Currently enrolling by invitation only

Purpose: To determine the prevalence of metaplasia and dysplasia in the gastric cardia before and after ablative therapy. To determine the incidence of cardiac metaplasia and dysplasia as a function of ablative therapy. To determine the correlation between dysplasia in the tubular esophagus, and dysplasia in the cardia.
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor
: CSA Medical, Inc.CSA medical.jpg

Visit clinicaltrials.gov to learn more about Prevalence of Dysplasia of the Gastric Cardia


A Dose-Optimization Study for the Initial Treatment of Dysplastic Barrett’s Esophagus with trūFreeze™ Spray Cryotherapy (DOSE Study)

Currently enrolling by invitation only

Purpose: This post-marketing study is being conducted to determine the optimum starting dose of spray cryotherapy for the treatment of dysplastic Barrett’s Esophagus (BE).  Patients undergoing ablation with the FDA-approved truFreezeTM cryotherapy device will be assigned to receive one of four pre-determined starting doses of cryotherapy.  All doses used in the study fall within the currently recommended therapeutic range for the treatment of BE.   
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor
: CSA Medical, Inc.CSA medical.jpg  
CSA TruFreeze Website

Visit clinicaltrials.gov to learn more about DOSE Study


trūFreeze™ Spray Cryotherapy Patient Registry

Currently enrolling by invitation only

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


Stratifying risk in Barrett's Esophagus: A pilot study for biomarker-based patient management

Currently enrolling by invitation only

Purpose: To gather information on the feasibility of a prospective, international multicenter study in which, on the basis of biomarker-based risk stratification, patients at high risk for progression are randomized to radiofrequency ablation (RFA) vs. a yearly surveillance EGD arm, while patients in the low risk group have an attenuated EGD surveillance regimen per current standard of care.
Principal Investigator:
Dr. Nicholas Shaheen, MD, MPH
Sponsor
: American Society for Gastrointestinal Endoscopy (ASGE)

Visit clinicaltrials.gov to learn more about Stratifying Risk in BE Pilot Study


Effect of Dexlansoprazole (Dexilant) on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett's Esophagus (BE) with Radiofrequency Ablation

Currently enrolling by invitation only

Purpose: To study the effect of once daily versus twice daily dexlansoprazole (Dexilant) dosing on the recurrence of intestinal metaplasia (IM) in subjects who achieved complete eradication of Barrett's esophagus (BE) with high-grade dysplasia (HGD) following radiofrequency ablation (RFA).
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor
: Takeda

Visit clinicaltrials.gov to learn more about Effect of Dexilant on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of BE with Radiofrequency Ablation


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


Wide Area Transepithelial Sample Esophageal Biopsy combined with computer assisted 3-dimensional analysis (WATS) For the Detection of Esophageal Dysplasia

Currently enrolling by invitation only

Purpose: This is a multi-center study to determine if the combination of WATS and "random biopsies" will have a higher detection rate of Barrett's associated neoplasia (high grade dysplasia/esophageal adenocarcinoma) compared to "random biopsies" alone.
Principal Investigator: Dr. Nicholas Shaheen, MD, MPH
Sponsor: CDx Diagnostics


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

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