Check-Cap is Inching Toward the U.S. Market with Positive Pilot Results

Check-Cap Ltd. is reporting positive results from a pilot study of its C-Scan System. The Isfiya, Israel-based company’s C-Scan System is a preparation-free ingestible scanning capsule-based system for the prevention of colorectal cancer through the detection of precancerous polyps. Results from the pilot study show that no device or procedure-related serious adverse events were reported and all device or procedure-related adverse events were mild in severity. In total, 45 patients enrolled in the study, of which 40 patients underwent the study procedure. All 40 patients complied with the procedure and completed a questionnaire following the procedure and reported higher satisfaction with the C-Scan System procedure compared to colonoscopy. A total of 28 patients were evaluable after factoring in technical and physiological dropouts and protocol violations. Analysis of the evaluable patient results revealed an agreement between C-Scan and colonoscopy in detection of polyps was consistent with data from the post-CE approval study. In a release, Alex Ovadia, CEO of Check-Cap, commented, "We are pleased with the positive results from this U.S. pilot study. Completing our first study in the U.S. constitutes an important milestone for our company as we work towards the initiation of a U.S. pivotal study in late 2020. We are now focused on preparing our IDE submission to FDA and collecting additional clinical data utilizing a new version of our C-Scan System,...
Source: MDDI - Category: Medical Devices Authors: Tags: Imaging Digital Health Source Type: news

Related Links:

Abstract A 60-year-old Caucasian male was diagnosed with lung adenocarcinoma and multiple metastases to the bone, spleen, and brain. He underwent radiotherapy for the brain and lumbar spine metastases, plus chemotherapy (cisplatin and pemetrexed). The chemotherapy was discontinued due to vomiting and hyponatremia, and nivolumab was then administered. Eight months later, 18F-fluorodeoxyglucose positron emission tomography showed tracer uptake in the colon. Colonoscopy revealed a reddish multinodular polyp in the sigmoid colon. The polyp showed irregular microvessels. No colonic mucosal surface structures were obser...
Source: Acta Med Okayama - Category: Universities & Medical Training Authors: Tags: Acta Med Okayama Source Type: research
Cosmeri Rizzato1, Javier Torres2, Elena Kasamatsu3, Margarita Camorlinga-Ponce2, Maria Mercedes Bravo4, Federico Canzian5 and Ikuko Kato6* 1Department of Translation Research and of New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy 2Unidad de Investigación en Enfermedades Infecciosas, Unidades Médicas de Alta Especialidad Pediatría, Instituto Mexicano del Seguro Social, Mexico City, Mexico 3Instituto de Investigaciones en Ciencias de la Salud, National University of Asunción, Asunción, Paraguay 4Grupo de Investigación en Biología del C&aacut...
Source: Frontiers in Microbiology - Category: Microbiology Source Type: research
Cancer of the esophagus is often related to chronic heartburn, something patients too often end up ignoring. The onset of the potentially deadly disease can be detected, though, given good enough imaging and regular screenings. The imaging component,...
Source: Medgadget - Category: Medical Devices Authors: Tags: Exclusive GI Pathology Surgery Source Type: blogs
Check-Cap is getting one step closer to having its capsule-based screening method for colorectal cancer on the U.S. market. The Isfiya, Israel-based company has received FDA conditional approval for an IDE to initiate a pilot study of the C-Scan capsule. FDA’s conditional approval of the IDE requires Check-Cap to provide additional information to the agency and the company may begin enrolling patients immediately upon approval by the study site's Institutional Review Board (IRB). The trial will consist of up to 45 patients and it will be a single-arm study. Patients who are enrolled will be those conside...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Implants Source Type: news
ConclusionDespite the advancement in visualization of anatomy with CT scan and laparoscopic appendicectomy there is still a role for screening colonoscopy in patients greater than 50 years of age with appendicitis particularly if they have associated bowel symptoms or risk factors for CRC.
Source: Annals of Medicine and Surgery - Category: General Medicine Source Type: research
Check-Cap (NSDQ:CHEK) today released interim results from the post-CE Mark approval study of its C-Scan system version 3, touting the device’s ability to detect polyps in un-prepped colons. The Israel-based company’s C-Scan system is designed as an alternative to standard colon cancer screening methods. The system uses an ingestible, ultra-low dose X-ray capsule and a wireless tracking system to return structural information on the lumen of the colon to create 2D and 3D maps. The study aimed to assess the safety and clinical performance of the C-Scan system version 3 in detecting polyps, Check-cap said. Da...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Diagnostics Oncology Check-Cap Source Type: news
Conditions:   Colo-rectal Cancer;   Polyps of Colon Intervention:   Diagnostic Test: Screening colonoscopy according to resect-and-discard strategy Sponsors:   Centre hospitalier de l'Université de Montréal (CHUM);   Pentax Medical Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
More News: Cancer | Cancer & Oncology | Colon Cancer | Colonoscopy | Colorectal Cancer | Gastrointestinal Polyps | Israel Health | Medical Devices | Middle East Health | PET Scan | Polyps | Study