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Clinical Studies
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Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples for the Non-endoscopic detection of Barrett’s esophagus with and without dysplasia (SOS4C TRIAL)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to measure DNA yield from esophageal cytology samples collected with the Cytosponge device in comparison to historical ranges observed from esophageal cytology samples collected with the EsophaCap (from IRB 15-004540).
Also, to evaluate MDM levels and accuracy of the Oncoguard® Esophagus test (OGE test) for the detection of methylated DNA markers in Cytosponge-collected esophageal cytology samples in comparison to historical ranges of MDMs and accuracy observed from esophageal cytology samples collected with the EsophaCap (from IRB 15-004540).
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Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma
Rochester, Minn.,
Eau Claire, Wis.,
Austin, Minn.
This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection, in a screening population, with and without chronic gastroesophageal reflux disease.
Closed for Enrollment
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A Dose-Optimization Study for the Initial Treatment of Dysplastic Barrett's Esophagus With truFreeze™ Spray Cryotherapy ("DOSE" Trial)
Jacksonville, Fla.
The primary objective of this study is to determine the percentage segment regression after spray cryotherapy in a dose-escalation study performed in patients with dysplastic Barrett's Esophagus (BE) using truFreeze spray cryotherapy within the currently recommended therapeutic range. Secondary objectives are the determination of safety related outcomes such as esophageal stricture.
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A Randomized, Double-Blind, Phase 4 Study to Evaluate the Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett's Esophagus With Radiofrequency Ablation
Jacksonville, Fla.
This study is designed to evaluate the effect of dexlansoprazole QD and BID 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).
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An International, Multicenter, Prospective, Post Market Registry Using a New Device for Endoscopic Resection of Early Neoplasia in Barrett's Esophagus
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to confirm the performance of the Captivator™ endoscopic mucosal resection device for resection of early tumor growth in Barrett's Esophagus.
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Biologic Repository for Esophageal Disease (BRED)
Jacksonville, Fla.
The purpose of this study is to develop a Biobank of blood and tissue collected from individuals with known or suspected Barrett’s esophagus , esophageal adenocarcinoma, squamous dysplasia and carcinoma.
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Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique (BURN) (BURN)
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The purpose of this study is to investigate if Hybrid Argon Plasma Coagulation (HAPC) is non-inferior to Radiofrequency Ablation (RFA) in the stricture-free eradication of the dysplastic Barrett's Esophagus (BE) epithelium.
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Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma
Mankato, Minn.,
La Crosse, Wis.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection, in a screening population, with and without chronic gastroesophageal reflux disease.
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Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma by a Sponge on String Device
Rochester, Minn.,
Jacksonville, Fla.,
Austin, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate if the capsule sponge device can detect the presence of Barrett's Esophagus.
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Notch Signaling and Novel Biomarkers for Barrett’s Esophagus (BETRNet)
Jacksonville, Fla.
The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus.
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