News | Colonoscopy Systems | September 04, 2018

Check-Cap Announces Interim Results of European Study of C-Scan System Version 3

Ingestible capsule-based device shows 76 percent sensitivity and 80 percent specificity for colorectal cancer polyp detection

Check-Cap Announces Interim Results of European Study of C-Scan System Version 3

September 4, 2018 — Check-Cap Ltd. announced the interim results for its post-CE approval study of the C-Scan system Version 3, an ingestible, capsule-based device for preparation-free colorectal cancer (CRC) screening. The company said data from the multicenter clinical investigation showed promising results for detecting patients with polyps in an un-prepped colon.

The objective of the study is to assess safety and clinical performance of the C-Scan system Version 3 in detecting patients with polyps. In a recent multicenter study on 31 evaluable patients, the C-Scan system Version 3, equipped with improved algorithms, demonstrated a sensitivity of 76 percent (P=0.0038), with specificity of 80 percent for polyp detection, when using the full patient population with a gender-based analysis. Confirmatory colonoscopy and C-Scan system results analysis were performed by independent expert investigators who were blinded to corresponding tests’ results.

Improvements to the C-Scan system version 3 include better scan imaging density, 2-D/3-D imaging, and a new motility analysis algorithm that was recently tested on two years of continued clinical study data.

Prof. Nadir Arber, M.D., principal investigator and professor of internal medicine and gastroenterology and head of the Health Promotion Center and Integrated Cancer Prevention Center at the Tel-Aviv Sourasky Medical Center, Israel, stated, "I believe that these interim clinical results demonstrate the C-Scan system's potential to become a meaningful colon cancer prevention device." He continued, "Despite the large body of evidence suggesting that polyp detection and removal can decrease CRC incidence and mortality, the screening adherence among target population is still relatively low. By maintaining this level of clinical performance, C-Scan has the ability to influence screening adherence for those who are unable to undergo a colonoscopy or are unwilling to choose standard CRC screening tests for precancerous polyp detection or stool collection (known to be less effective for precancerous polyp detection) due to common barriers such as unpleasant bowel preparation requirements, invasiveness or stool collection. C-Scan continuously supports the promise to provide a patient-friendly option that could potentially increase CRC screening rates and save lives."

Prof. Jan Tack, M.D., Ph.D., professor of medicine, Translational Research Center for Gastrointestinal Disorders (TARGID), University of Leuven. Department of Clinical and Experimental Medicine, University of Leuven and head of clinic, University Hospital Gasthuisberg, Department of Gastroenterology, stated, "I believe that the diagnostic yield of the C-Scan system, based on the combined diagnostic test, including scan imaging and gut motility, can be accepted as an important CRC screening tool following results 'validation on a larger data base."

Prof. Yehuda Ringel, M.D., chief, Division of Gastroenterology and Hepatology at Meir Medical Center, affiliated with Tel Aviv University and adjunct professor of medicine at the University of North Carolina at Chapel Hill, stated, "The novel data on possible association between intestinal motility and colon polyps may provide new insight into the natural history of CRC. Identifying intestinal motility as a contributing risk factor for CRC has the potential to further improve screening protocols for patients at risk for CRC."

Colorectal cancer is the second leading cause of cancer death in the United States, with an estimated 135,000 diagnoses and 50,000 deaths in 2017. Despite compelling evidence that screening can detect colorectal cancer and precancerous polyps, nearly one-third of the recommended adult population has never been screened. The C-Scan® system is designed to improve patient experience with screening by eliminating many uncomfortable and invasive requirements of other colon screening procedures, such as bowel preparation, fasting and sedation.

Check-Cap CEO Alex Ovadia said final results for the post-CE approval study on a more substantial number of patients are planned for the second quarter of 2019. He said the company still plans to deliver on its near-term goals for the remainder of 2018 and forward, including the establishment of a manufacturing line through GE Healthcare.

A U.S. pilot trial of the C-Scan system Version 3 is planned to begin in the fourth quarter of this year.

For more information: www.check-cap.com

Related Content

NIH Study of Brain Energy Patterns Provides New Insights into Alcohol Effects

NIH scientists present a new method for combining measures of brain activity (left) and glucose consumption (right) to study regional specialization and to better understand the effects of alcohol on the human brain. Image courtesy of Ehsan Shokri-Kojori, Ph.D., of NIAAA.

News | Neuro Imaging | March 22, 2019
March 22, 2019 — Assessing the patterns of energy use and neuronal activity simultaneously in the human brain improve
Researchers Use Radiomics to Predict Who Will Benefit from Chemotherapy
News | Radiomics | March 21, 2019
Using data from computed tomography (CT) images, researchers may be able to predict which lung cancer patients will...
Older Biologic Age Linked to Elevated Breast Cancer Risk
News | Women's Health | March 19, 2019
Biologic age, a DNA-based estimate of a person’s age, is associated with future development of breast cancer, according...
HeartFlow Analysis Successfully Stratifies Heart Disease Patients at One Year
News | CT Angiography (CTA) | March 19, 2019
Late-breaking results confirm the HeartFlow FFRct (fractional flow reserve computed tomography) Analysis enables...
PET Scans Show Biomarkers Could Spare Some Breast Cancer Patients from Chemotherapy
News | PET Imaging | March 18, 2019
A new study positron emission tomography (PET) scans has identified a biomarker that may accurately predict which...
SyncVision iFR Co-registration from Philips Healthcare maps iFR pressure readings onto angiogram.

SyncVision iFR Co-registration from Philips Healthcare maps iFR pressure readings onto angiogram. Results from an international study presented at #ACC19 show that pressure readings in coronary arteries may identify locations of stenoses remaining after cardiac cath interventions.

Feature | Cardiac Imaging | March 18, 2019 | By Greg Freiherr
As many as one in four patients who undergo cath lab interventions can benefit from a technology that identifies the
Non-Contrast MRI Effective in Monitoring MS Patients
News | Neuro Imaging | March 18, 2019
Brain magnetic resonance imaging (MRI) without contrast agent is just as effective as the contrast-enhanced approach...
Bay Labs Announces New Data on EchoGPS, AutoEF AI Software at ACC.19
News | Cardiovascular Ultrasound | March 15, 2019
Artificial intelligence (AI) company Bay Labs announced the presentation of two studies assessing performance of the...
Hologic Receives CE Mark for Three-in-One Omni Hysteroscope
News | Endoscopes | March 14, 2019
Hologic Inc. announced it has received a CE mark in Europe for its Omni hysteroscope, a three-in-one modular scope with...
Researchers Create New Method for Developing Cancer Imaging Isotopes

Prototype fluidic system for zirconium-89 purification. Image taken through a hot cell window at the Department of Radiology, University of Washington. Image courtesy of Matthew O’Hara, Pacific Northwest National Laboratory

News | Radiopharmaceuticals and Tracers | March 14, 2019
A team of researchers at the University of Washington announced they developed a new automated system for producing...