Healthy Subjects
Conditions
Brief summary
The purpose of the first part of the study (subgroup R&D) is to demonstrate the safety and performance of the C-Scan system and to collect data in order to improve the analysis process. The purpose of the second part of the study (subgroup pre-pivotal) is to determine the ability of the C-Scan System to identify elevated risk subjects
Interventions
DEVICEC-Scan System
Subjects will be provided with contrast agent and dietary fiber pills, and instructed to start intake approximately 48 hours prior to the planned C-Scan procedure start. C-Scan system intervention includes ingestion of the C-Scan Cap and attachment of the C-Scan track to the subject's lower back. The subject is required to keep the C-Scan Track attached to the lower back and to continue intake of contrast agent and dietary fiber pills until the C-Scan Cap's natural excretion. Standard of care optical colonoscopy will be performed within 60 days from the C-Scan Cap ingestion.
Sponsors
Check-Cap Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or Female at the age of 50-75 years old 2. Able to provide a signed informed consent. 3. Willing and able to comply with the specified study requirements and can be contacted by telephone. 4. Scheduled for colonoscopy procedure within 60 days of C-Scan ingestion within the research institution's system.\* 5. Maximum body (abdominal) circumference \< 125 cm.
Exclusion criteria
1. Subject who is not a suitable candidate for a colonoscopy 2. Known history of dysphagia or other swallowing disorders. Third (3rd) and fourth (4th)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the ability of the C-Scan System to identify elevated risk subjects | 60 days | Sensitivity for detecting subjects with elevated risk for polyps |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of device or procedure related adverse events | Up to 7 days post C-Scan procedure completion | Analysis of safety data |
| Satisfaction with the C-Scan procedure assessed by a questionnaire | Up to 7 days post C-Scan procedure completion | Satisfaction questionnaire to be completed by the subject |
| Satisfaction with the C-Scan procedure compared to colonoscopy assessed by a questionnaire | Up to 7 days post colonoscopy | Satisfaction questionnaire to be completed by the subject |
| Evaluate the Whole Gut Transit Time | During the C-Scan procedure | Time elapsed from capsule ingestion to excretion |
Countries
Israel
Contacts
Primary ContactHanit Brenner- Lavie, PhD
Backup ContactDaniella Bleistein, MSc
Outcome results
None listed