Israeli medical diagnostics maker Check-Cap is set to initiate a pilot study in the US to assess its C-Scan System for the prevention of colorectal cancer by detecting precancerous polyps.
The company has secured approval from the Institutional Review Board (IRB) at the New York University School of Medicine to conduct the study.
C-Scan System is a preparation-free capsule-based screening test. It comprises an ingestible ultra-low-dose X-ray capsule and software for 3D mapping of the inner lining of the colon.
The capsule is said to act as an integrated positioning, control and recording system. It moves through the gastrointestinal tract by natural motility.
Check-Cap CEO Alex Ovadia said: “We are excited to receive IRB approval as this important milestone enables Check-Cap to bring the C-Scan system into the clinic in the US.
“We look forward to the initiation of the pilot study evaluating our patient-friendly screening method for colorectal cancer as we aim to increase screening adherence and ultimately decrease the overall incidence for this highly-preventable disease.”
The single-arm pilot study will assess the safety, usability and subject compliance of the C-Scan System in up to 45 participants who are considered to be at average risk of developing polyps and colon cancer.
Colon cancer affects the large intestine and most cases begin as small non-cancerous polyps, which can become cancerous over time and must be monitored over a patients lifetime.
Check-Cap expects to complete the study by September this year.
Check-Cap partnered with GE Healthcare in August 2016 to develop and assess the capsule-based test.
Last year, the company received the European CE-Mark clearance and the approval in Israel to begin commercial sales of the C-Scan system.
Additional reporting by Charlotte Edwards.