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Endoscopic Full Thickness Biopsy of the Gastric Wall in Patients With Refractory Idiopathic Gastroparesis: Pilot Study to Detect Neuromuscular and Immune Pathologic Changes
Rochester, Minn.
The proposed study will assess the efficacy and safety of the innovative endoscopic technique for the acquisition of full thickness gastric muscle wall biopsies. Having access to full thickness biopsies will allow an increased understanding of the pathophysiology of gastrointestinal diseases such as functional gastrointestinal disorders, gastroparesis, pseudoobstruction and other motility disorders. This information is essential to development of more targeted and effective therapy than currently available. Despite the high prevalence of functional gastrointestinal disorders and its significant impact on social and health care costs, the underlying cause is not well understood and there is no effective specific treatment to successfully alleviate patient symptoms.
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Evaluation of C-Scan Capsule in Identifying Subjects With Elevated Risk of Colon Polyps
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The main objective of the study is to determine the ability of the C-Scan system to identify subjects who are at elevated risk for colon polyps. This will be evaluated by comparing the C-Scan data to colonoscopy data. The C-Scan procedure is therefore performed before the colonoscopy procedure, in order to compare these tests and evaluate the C-Scan system's effectiveness. During the C-scan procedure, Subjects will be asked to come for an appointment in a clinic. during this appointment, The C-Scan Track will be attached to the subject's back. Subjects then will be asked to swallow the C-Scan capsule and will be released from the clinic to their routine. Subjects will be asked to ingest contrast agent fluid and fiber pills starting 48 hours before capsule swallowing, up to capsule natural excretion. Standard colonoscopy procedure will be performed within 60 days following the C-Scan Cap swallowing.
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Evaluation of Safety, Usability and Subject Compliance While Using Check- Cap's C-Scan System for Providing Structural Information on Colonic Polypoid Lesions and Masses (C-Scan)
Rochester, Minn.
The primary purpose of this study is to evaluate the safety of the Check-Cap C-Scan System.
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Multicenter, Prospective, Randomized Study Comparing the Diagnostic Yield of Colon Capsule Endoscopy versus Computed Tomographic Colonography in a Screening Population (TOPAZ)
Rochester, Minn.
The purpose of this study is to compare the effectiveness of Colon Capsule Endoscopy versus Computed Tomographic Colonography for the screening of colon polyps in the usual screening population.
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Prospective, Open Label, Pivotal Study of the Accuracy of the CapsoCam® Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the safety and effectiveness of CapsoCam® Colon (CV-3) endoscope system for the detection of colonic polyps. It is anticipated that the data from this clinical trial will be used to support marketing authorizations to commercialize the CapsoCam® Colon (CV-3).
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Quality Assessment of Colon Capsule Endoscopy
Rochester, Minn.
The primary aims of the study include determining the patient’s experience with colon capsule endoscopy (CCE) and the associated bowel preparation. In addition, the nursing staff experience with administration of the colon capsule will also be noted. Finally, the physician’s experience with interpretation of the colon capsule images. The secondary aim of this study is preliminary evaluation of the diagnostic yield of CCE compared to CT colonography (CTC).
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