Colorectal Cancer Screening Pill to Be in US Pilot Study
Check-Cap is getting one step closer to having its capsule-based screening method for colorectal cancer on the U.S. market. The Isfiya, Israel-based company has received FDA conditional approval for an IDE to initiate a pilot study of the C-Scan capsule.
FDAâs conditional approval of the IDE requires Check-Cap to provide additional information to the agency and the company may begin enrolling patients immediately upon approval by the study site's Institutional Review Board (IRB). The trial will consist of up to 45 patients and it will be a single-arm study. Patients who are enrolled will be those considered to be of average risk for polyps and colon cancer. The study will also evaluate C-Scanâs safety, usability, and subject compliance.
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Alex Ovadia, Check-Capâs CEO said FDAâs conditional approval for an IDE is a significant milestone for the company.
âFollowing this conditional approval, we are applying for approval from the IRB and making sure we can start or initiate the pilot at NYU, which is our selected site,â Ovadia, told MD+DI.
Hereâs how C-Scan works. After being swallowed in capsule form, the C-Scan system's ultra-low-dose X-ray technology is used to produce a 3-D map of a patient's colon. The system differs from capsule technology alrea...
Source: MDDI - Category: Medical Devices Authors: Omar Ford Tags: Regulatory and Compliance Implants Source Type: news
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