May 26, 2016 — Check-Cap Ltd. announced that preliminary data from pre-clinical and clinical studies of its ingestible capsule for preparation-free colorectal cancer screening were discussed during Digestive Disease Week (DDW) 2016, May 21-24 in San Diego.
The presentation included a preliminary analysis of the first participants evaluated in the company's ongoing multi-center clinical feasibility study, which aims to establish the safety, functionality and preliminary efficacy of the Check-Cap system.
"While the potential health benefits of routine colorectal cancer screening are well understood, many patients are unwilling to undergo standard optical colonoscopy due to a perception of inconvenient bowel preparation requirements, concerns over pain and risks associated with anesthesia. Additionally, more than 20 percent of patients undergoing colonoscopy have inadequate bowel preparation, increasing the likelihood of complications and missed adenomas," said Prof. Nadir Arber, M.D., director of the Integrated Cancer Prevention Center (ICPC) at Tel Aviv Sourasky Medical Center, president of the Israeli Association of Gastroenterology and a lead investigator in the company's ongoing multi-center study.
"Preliminary findings demonstrated the feasibility of an alternative screening method that can generate structural data of the colon, without burdensome cleansing or diet restrictions, as required in current screening methods. These data support the Check-Cap system as a potentially attractive option for individuals in the target patient population that are not adherent to current medical guidelines."
Data presented showed safe and complete passage for the 75 participants enrolled in a completed study to assess the natural motility of the capsule. Preliminary analysis of the ongoing clinical feasibility study evaluated data from 54 participants who swallowed Check-Cap's scanning capsule, tracking the passage of the capsule through the alimentary tract using radio frequency telemetry and Check-Cap's proprietary capsule position tracking system.
Capsule passage was safe and well-tolerated, with an average transit time of 66 ±37 hours observed in 53 volunteers who completed the study (one asymptomatic volunteer withdrew prior to completion and the capsule was retrieved endoscopically from the colon), and the total radiation dose was found to be ultra-low (0.03±0.007 mSv, or the equivalent exposure of one dental or chest X-ray). Three-dimensional image reconstructions of the colonic wall and lumen detected and located small and large pedunculated and sessile polyps, as validated by subsequent colonoscopy.
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