An analysis of 45 procedures performed demonstrated the sensitivity of both approaches for polyp detection: 44% using the capsule and 37% using FIT.
Capsule sensitivity increased to 78% to 100% when more than 50% to 70% of the colon surface area was imaged, respectively, with a linear correlation between imaged area and sensitivity. Specificity varied from 86% to 90%. Optimized scanning algorithms will be applied to future studies.
The average transit time was 52 hours with no device-related serious adverse events.
Ongoing and future trials
Dr. Rajan and colleagues are collaborating in the first U.S. Prospective single-arm pilot study evaluating the safety and compliance of this prepless capsule in asymptomatic participants considered to be of average risk of polyps and colon cancer. Preliminary results are promising, and Dr. Rajan and co-investigators expect to publish results from that trial in early 2020. The next step will be a multicenter pivotal study.
“Each phase of this research helps us progress toward the goal of offering patients the option of a prepless, X-ray-based imaging capsule as a screening tool for CRC,” says Dr. Rajan. Establishing the safety and efficacy of this screening test may more nonadhering patients to comply with recommended screening, which would, in turn, help encourage the overall incidence of CRC.
