NCT03356002

Evaluation of C-Scan System in Providing Structural Information and Detection of Polypoid Lesions in High Risk Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Check-Cap Ltd. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to establish the efficacy of Check-Cap's C-Scan System in providing structural information on colonic polypoid lesions and masses, as an adjacent tool to Feacal Immunochemical Test \[FIT\] in high risk subjects

Detailed description

The subject will be invited to come to the clinic to sign the Informed Consent Form \[ICF\] and other related . The subjects will be connected to the C-Scan Track and following system's activation the subject will be asked to ingest the C-Scan Capsule with some water and contrast media, in the presence of a physician. Post ingestion, the subject will be discharged home with clear instructions on the procedure. The subject should avoid intensive physical exercise during procedure or any extreme activities. The subject should make an effort to stay at home or other familiar surroundings, and may continue daily activities such mobile/computer/Television use, shower, sleep or eat. Details on allowed and restricted activities are listed in app. 4 The subject will be required to ingest daily dose (3 X 15-17ml) of contrast media, to be consumed three times per day with normal diet. Also on a need based the subject would be provided with laxadine (5 mg tablets) to be ingested according to the doctor recommendation. During capsule procedure the subjects will be contacted by phone several times daily by the site clinical study team (or by dedicated external trained medical personnel), to assure the subjects well-being and to monitor for any change or discomfort and for procedure progress. Subjects may be also monitored by the technical team (either at home or at the clinic), who may need to examine the system or inquire the subjects about the system visual/auditory indicators. The subjects will be provided with a dedicated capsule collection kit, to assist the subjects in collecting the capsule. Subjects will be instructed to retrieve the capsule upon excretion. Capsule procedure is completed upon capsule excretion or system vibro/auditory indication of 'End of Procedure'. Once the procedure is completed, The C-Scan Capsule and C-Scan Track will be collected from the subject and returned to the sponsor's lab for preliminary analysis. All subjects will be scheduled for optical colonoscopy to be performed within one month following capsule procedure. C-Scan Procedure Analysis: Several (3-6) licensed gastroenterologist physicians, will be trained with reviewing and analyzing C-Scan System scans, to serve as independent reviewers. Each case will be reviewed by 3 independant reviewers. The reviewing forum will be blinded to the FIT and colonoscopy results of the examined patients. Analysis will be performed on a per patient basis for the existence or non-existence of a finding that may be a polyp. This per patient finding will be compared with the FIT, and a colonoscopy will be performed for verification.

Conditions

• High Risk (Above Average) Subjects
• Non Compliant Patients for Colo Rectal Cancer [CRC] Screening
• Counterindicated Patients for Colonoscopy

Interventions

Type	Name	Description
DEVICE	C-Scan System	Each subject will ingest the capsule within 30 days prior to colonoscopy. The results of the C-Scan review will be compared to the findings of colonoscopy. 1. To establish the efficacy of C-Scan Capsule System and FIT in detecting patients with polypoid lesions ≥ 10mm, compared with Optical Colonoscopy 2. To evaluate the safety of the C-Scan Capsule System procedure

Timeline

• Start date: 2018-01-28
• Primary completion: 2020-01-26
• Completion: 2020-01-26
• First posted: 2017-11-29
• Last updated: 2020-02-07

Locations

7 sites across 1 country: Israel