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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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Clonal Diversity of Freshly Taken ESD Specimens
Rochester, Minn.
Inclusion Criteria:
- Patients with Barrett’s Esophagus (BE) or Esophageal Adenocarcinoma (EAC) that are planned for Endoscopic Submucosal Dissection (ESD) treatment.
Exclusion Criteria:
- Patients without BE or EAC or that are not planned for ESD treatment.
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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.
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Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE) (NO FEAR-BE) (NO FEAR-BE)
Rochester, Minn.
The purpose of this multicenter, prospective, single arm, non-randomized clinical trial to evaluate the safety and efficacy of the C2 CryoBalloon Focal Ablation System (CbFAS) 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 Barrett's Esophagus (BE) after 2 RFA treatments.
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The SURVENT Trial: A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus with Low-grade Dysplasia
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to compare the effectiveness of two approaches for the management of Barrett's Esophagus (BE) and Low-grade Dysplasia (LGD), endoscopic surveillance and endoscopic eradication therapy (EET), using accepted clinical endpoints of neoplastic progression [high-grade dysplasia (HGD)/mucosal esophageal adenocarcinoma (EAC)/invasive EAC] as determined by a blinded central committee.
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Closed for Enrollment
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Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?: A Randomized Controlled Trial
Rochester, Minn.
The investigators hypothesize that intensive acid suppression with a long acting high potency proton pump inhibitor (dexlansoprazole) will lead to a greater decrease in levels of inflammatory mediators (compared to conventional PPIs) in the esophagus, which could potentially lead to decreased recurrence of intestinal metaplasia following endoscopic ablation.
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Epidemiology of Barrett's Esophagus: A Population Based Study
Rochester, Minn.
To assess attitudes toward screening for esophageal adenocarcinoma (EAC) and Barrett's esophagus (BE) in the community.
To develop a population based clinical risk factor prediction model for the diagnosis of BE and identify novel risk factors for BE which would make population based screening more efficient. This will be an important first step in identifying the target population for BE screening, another crucial component of making screening feasible and efficient.
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Influence of Central Obesity on the Esophageal Epithelial Barrier
Rochester, Minn.
This study is being done to help understand why some people with an increased amount of central obesity, without gastroesophageal reflux, develop changes to the lining of their esophagus that can potentially lead to esophageal adenocarcinoma (cancer).
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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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Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids, a Double Blind Placebo Controlled Randomized Pilot Study
Rochester, Minn.
Will oral supplementation with Omega 3 free fatty acids in obese Barrett's esophagus subjects downregulate pro-neoplastic and pro-inflammatory pathways in the esophagus to anti-inflammatory pathway?
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Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System for the Treatment of Patients With Previously Untreated Dysplastic Barrett's Epithelium (ColdPlay3)
Rochester, Minn.
To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)
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Prospective Characterization of the Neo-squamous Epithelial Barrier Following Successful Endoscopic Therapy in Barrett's Esophagus
Rochester, Minn.
To prospectively assess the functional aspects of the the esophageal squamous epithelial barrier and correlate this with tissue inflammation and intercellular space dilation in patients who have successfully completed endoscopic therapy for Barrett's Esophagus related metaplasia.
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Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy
Rochester, Minn.
Will EG Scan (transnasal endoscopy) determine presence of Barrett's Esophagus, esophagitis and hiatal hernia as well as standard sedated endoscopy.
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Shared Decision Making in Barrett’s Esophagus (with Low Grade Dysplasia) – BE Choice
Rochester, Minn.
The purpose of this study is to develop an evidence-based management decision aid for patients who have Barrett's Esophagus with low grade dysplasia, called BE Choice. To evaluate the impact of the developed decision aid (BE Choice) on patient-centered outcomes, assessments will be made of patient knowledge, decision conflict, patient involvement in decision-making, treatment choice, and outcomes when compared to ‘usual specialist care’.
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The Role of Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury
Rochester, Minn.
Is waist to hip ratio (WHR), waist circumference (WC), (as markers of visceral adiposity) associated with an increase in acidic and non acidic reflux as well as systemic inflammation involving esophageal mucosa, thereby increasing esophageal injury and predisposing to subsequent development of Barrett's esophagus (BE)?
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Utility of Aberrant Gene Methylation in the Diagnosis of Barrett's Esophagus and Dysplasia in Barrett's Esophagus: Identification of Candidate Diagnostic Markers
Rochester, Minn.
This study is to identify potential markers from esophageal biopsies and brush cytology for feasibility of use in stool specimens for detection of Barretts Esophagus.
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