{"id":2272,"date":"2014-01-15T16:25:00","date_gmt":"2014-01-15T21:25:00","guid":{"rendered":"https:\/\/med.sites.unc.edu\/cedas\/research-1\/current-research-studies\/"},"modified":"2024-02-22T14:44:20","modified_gmt":"2024-02-22T19:44:20","slug":"current-research-studies","status":"publish","type":"page","link":"https:\/\/www.med.unc.edu\/cedas\/research-1\/current-research-studies\/","title":{"rendered":"Barrett’s Esophagus (BE) Research Studies"},"content":{"rendered":"

Currently Enrolling<\/h1>\n\n\n\n\n\n\n\n\n
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N<\/u>itrous O<\/u>xide F<\/u>or E<\/u>ndoscopic A<\/u>blation of R<\/u>efractory B<\/u>arrett\u2019s E<\/u>sophagus (NO FEAR-BE)<\/h2>\n

Currently enrolling by invitation only<\/p>\n

Purpose: <\/strong>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.
\nPrincipal Investigator:<\/strong> Dr. Nicholas Shaheen, MD, MPH
\nSponsor:<\/strong> PENTAX of America, Inc.<\/div>\n

Visit clinicaltrials.gov to learn more about NO FEAR-BE<\/a><\/p>\n

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Advanced a\/LCI Systems for Improved Clinical Utility: An Optical Coherence Tomography (OCT) Pilot Study (OCT Pilot)<\/h2>\n

Currently enrolling by invitation only<\/p>\n

Purpose: <\/strong>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\u2019s Esophagus (BE) epithelium.
\nPrincipal Investigator:<\/strong> Dr. Nicholas Shaheen, MD, MPH
\nSponsor:<\/strong> National Cancer Institute (NCI)<\/div>\n

Visit clinicaltrials.gov to learn more about OCT Pilot<\/a><\/p>\n

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Non-Endoscopic Surveillance for Barrett’s Esophagus (BE) Following Ablative Therapy<\/h2>\n

Currently enrolling by invitation only<\/p>\n

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Purpose:<\/strong> 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\u2019s Esophagus (a change in the lining of the esophagus\/food tube from acid reflux).
\nPrincipal Investigator:<\/strong> Dr. Nicholas Shaheen, MD, MPH
\nSponsor:<\/strong> National Institutes of Health (NIH)<\/div>\n

Visit clinicaltrials.gov to learn more about\u00a0 Non-Endoscopic Surveillance for BE Following Ablative Therapy<\/a><\/p>\n

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A Prospective Single Arm Multicenter Study Evaluating the Effects of Spray Cryotherapy in Patients with Persistent Local Esophageal Cancer<\/h2>\n

Currently enrolling by invitation only<\/p>\n

Purpose:<\/strong> The primary objective of this registry is to study the effects of the tr\u016bFreeze\u00ae 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.
\nPrincipal Investigator:<\/strong> Dr. Nicholas Shaheen, MD, MPH
\nSponsor:<\/strong> CSA Medical, Inc.\"CSA<\/div>\n

Visit clinicaltrials.gov to learn more about tr\u016bFreeze\u00ae Esophageal Cancer <\/a><\/p>\n

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Genetic and Environmental Determinants of Barrett’s Esophagus (BE)<\/h2>\n

Currently enrolling by invitation only<\/p>\n

Purpose:<\/strong> This is a multi-center study whose aim is to define the epidemiology and genetics of Barrett\u2019s esophagus and adenocarcinoma.
\nPrincipal Investigator:<\/strong> Dr. Nicholas Shaheen, MD, MPH
\nSponsor:<\/strong> National Institute of Diabetes, Digestive, & Kidney Disease<\/div>\n

Visit clinicaltrials.gov to learn more about Genetic and Environmental Determinants of BE<\/a><\/p>\n

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UNC Barrett’s Esophagus and Esophageal Cancer Biorepository (BEECAB)<\/h2>\n

Currently enrolling by invitation only<\/p>\n

Purpose:<\/strong> To learn more about Barrett\u2019s Esophagus and esophageal cancer by collecting data and samples (blood and tissue) for a biorepository.
\nPrincipal Investigator:<\/strong> Dr. Nicholas Shaheen, MD, MPH
\nSponsor:<\/strong> University of North Carolina<\/div>\n

Visit clinicaltrials.gov to learn more about the BEECAB study<\/a><\/p>\n

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<\/h1>\n

Closed to Enrollment
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Coldplay 3: Multi-Center Clinical Study to Evaluate the Coldplay CryoBalloonTM Focal Ablation System for the Treatment of Patients with Previously-Untreated Dysplastic Barrett\u2019s Epithelium<\/h2>\n

Enrollment closed<\/p>\n

Purpose:<\/strong> To collect additional data on the efficacy and safety of the CryoBalloon System, specifically in the treatment of patients with previously untreated (treatment na\u00efve) Barrett\u2019s Esophagus.
\nPrincipal Investigator:<\/strong> Dr. Nicholas Shaheen, MD, MPH
\nSponsor:<\/strong> C2 Therapeutics<\/div>\n

Visit clinicaltrials.gov to learn more about Coldplay 3<\/a><\/p>\n

\"Clinicaltrials.gov\"<\/a><\/span><\/td>\n<\/tr>\n

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Assessment of a Minimally Invasive Esophageal Cytology Collection System in Patients with Barrett\u2019s Esophagus or GERD Symptoms<\/h2>\n

Enrollment closed<\/p>\n

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\n<\/strong><\/p>\n

Purpose:<\/strong> 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\u2019s 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).
\nPrincipal Investigator:<\/strong> Dr. Nicholas Shaheen, MD, MPH
\nSponsor:<\/strong> GI Solutions – Covidien<\/div>\n

Visit clinicaltrials.gov to learn more about Assessment of a minimally invasive esophageal cytology collection system in patients with BE or GERD <\/a><\/p>\n

\"Clinicaltrials.gov\"<\/a><\/td>\n<\/tr>\n

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International, Multicenter, Prospective, Post Market Registry Using a New Device for Endoscopic Resection of Early Neoplasia in Barrett\u2019s Esophagus – The Captivator\u2122 EMR Registry<\/h2>\n

Enrollment closed<\/p>\n

Purpose:<\/strong> To determine whether aspirin safely reduces the risk of re-developing BE after successful treatment.
\nPrincipal Investigator:<\/strong> Dr. Nicholas Shaheen, MD, MPH
\nSponsor:<\/strong> University of Texas MD Anderson Cancer Center, NCI<\/div>\n

Visit clinicaltrials.gov to learn more about the Captivator EMR Registry<\/a><\/p>\n

\"Clinicaltrials.gov\"<\/a><\/span><\/td>\n<\/tr>\n

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tr\u016bFreeze\u2122 Spray Cryotherapy Patient Registry<\/h2>\n

Enrollment closed<\/p>\n

Purpose:<\/strong> The primary objective of this registry is to collect efficacy data related to the use of truFreeze\u00ae spray cryotherapy in the pulmonary and gastrointestinal settings.
\nPrincipal Investigator:<\/strong> Dr. Nicholas Shaheen, MD, MPH
\nSponsor:<\/strong> CSA Medical, Inc.\"CSA<\/div>\n

Visit clinicaltrials.gov to learn more about the truFreezeTM<\/sup> spray Cryotherapy Patient Registry <\/a><\/p>\n

\"Clinicaltrials.gov\"<\/a><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

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Please contact us for more information regarding any of the above active CEDAS research studies:<\/p>\n