S0308 Prep-Free Screening Capsule to Redefine Colorectal Cancer Screening and Prevention

Abstract

INTRODUCTION: Colorectal cancer (CRC) can be prevented by removal of polyps during colonoscopy. Colonoscopy barriers include invasiveness and need of bowel cleansing preparation. Non-invasive CRC stool based tests may increase CRC screening adherence, but are not designed as a tool to identify pre-cancerous polyps. We present data from a novel prep-free colon cancer screening technology for the detection of pre-cancerous polyps. METHODS: An ingestible capsule descends through the gastrointestinal tract via natural motility and scans the colon for structural abnormalities using an ultra-low-dose X-ray source. The data is transmitted to a recorder unit attached to the patient. The test requires no preparation or sedation, allowing patients to continue their daily routine. A 187 patients were performed in the U.S. and Israel designed to assess the safety and effectiveness of the technology in detecting polyps. All sites received EC/IRB approvals. Patients ingested the capsule with a contrast agent and underwent a colonoscopy performed by independent gastroenterologists, who were blinded to the test's results. RESULTS: Sensitivity of the capsule in detecting clinically significant polyps (≥10 mm) was 76% and specificity was 82% with no severe or serious adverse events reported. Some patients reported mild abdominal pain and nausea. Patient characteristics are shown in Table 1. A survey questionnaire resulted with a score of 4.18 compared to a 2.91 for colonoscopy (P = 0.0011) using a scoring system of 1 (strongly disagree) to 5 (strongly agree) in response to the phrase: “I would recommend the test for colonic screening”. CONCLUSION: The reported patient satisfaction, sensitivity, specificity and safety highlights the potential of the capsule technology as a tool for CRC prevention. Further studies are needed to make this technology part of our routine colon cancer prevention armamentarium.Figure 1.: Polyp as detected by the capsule system compared to colonoscopy (endoscopic image).Table 1.: Patients Characteristic dataTable 2.: Capsule sensitivity and specificity