Filter Results
Clinical Studies
Results filtered:Study status:
Open
Closed for Enrollment
Closed for Enrollment
-
A Phase 2, Multi-center, Multi-national, Randomized, Double-blind, Placebo-controlled Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of RPC4046 in Adult Subjects With Eosinophilic Esophagitis
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment of Eosinophilic Esophagitis (EoE). This trial consists of two phases: 16 weeks of double-blind treatment and 24 weeks of open-label extension.
-
Analysis of Endoscopist Ophthalmologic Parameters Associated with Adenoma Detection Rate in Colonoscopy
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine baseline ophthalmologic parameters in a group of practicing endoscopists, to evaluate whether these parameters correlate with adenoma detection rates (ADR) and to construct a reproducible and widely applicable screening protocol that can be used to test the adequacy of visual parameters in practicing endoscopists.
-
Clinical Investigation to Evaluate Removal of the Evolution® Esophageal Stent - Fully Covered (CLARITY)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the endoscopic removability of the Evolution® esophageal fully covered stent when used to treat patients with an obstruction caused by cancer or strictures, or for fistulas, perforations, or leaks.
-
FLUTicasone in Eosinophilic Esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose-ranging, and Maintenance Study of APT-1011 in Subjects With Eosinophilic Esophagitis (FLUTE)
Scottsdale/Phoenix, Ariz.
Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal symptoms. Swallowed, topically acting corticosteroids, such as fluticasone, appear to be effective in resolving acute clinical and pathological features of EoE. APT-1011 is an orally disintegrating tablet (ODT) formulation of fluticasone propionate. This study is designed to compare the efficacy and safety of APT-1011 with placebo in adults with EoE for an initial 12-week treatment period, followed by an additional 40-week maintenance treatment phase. Histologic response, pharmacokinetics, and dysphagia will be assessed.
-
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.
-
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.
-
NvisionVLE® Imaging System Capsule Probe Feasibility Study
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine the feasibility and tolerability of obtaining esophageal VLE images using the NvisionVLE® Imaging System Capsule Probe.
-
Prospective, Randomized, Multicenter, Tandem Study Evaluating the Safety and Effectiveness of the CB-17-08 Augmented Endoscopy System for the Detection of Mucosal Colorectal Polyps in Adult Patients Undergoing Screening or Surveillance Colonoscopy for CRC
Jacksonville, Fla.,
Eau Claire, Wis.,
Scottsdale/Phoenix, Ariz.,
La Crosse, Wis.
The purpose of this study is to confirm the performance of the CB-17-08 software as a medical device (SaMD) to help endoscopist during the colonoscopy procedure to find potential mucosal lesions, including polyps, adenomas and carcinomas, without significant noise disturbing the endoscopist attention, nor negative interference with the lesions detection than with the standard endoscopy video alone. The study will evaluate whether high-definition white-light (HDWL) colonoscopy using CB-17-08 SaMD will have a lower miss rate of clinically significant polyps, as compared to standard HDWL colonoscopy alone (the current standard of care for colonoscopy).
-
The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies
Scottsdale/Phoenix, Ariz.
The purpose of this study is to compare the efficacy of a low-volume bowel preparation versus a high-volume bowel preparation for bowel cleansing on hospitalized patients undergoing colonoscopies.
-
Volumetric Laser Endomicroscopy With Intelligent Real-time Image Segmentation (IRIS): a Multi-center Randomized Prospective Study (IRIS)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to examine how IRIS (Intelligent Real-time Image Segmentation) affects biopsy patterns in VLE (Volumetric Laser Endomicroscopy).
.