Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT05271656
Status:
TERMINATED
Last Update Posted:
2023-07-28
First Post:
2022-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of C-Scan Capsule in Identifying Subjects With Elevated Risk of Colon Polyps
Sponsor:
Check-Cap Ltd.
Organization:
Study Overview
Official Title:
Evaluation of C-Scan Capsule in Identifying Subjects With Elevated Risk of Colon Polyps
Status:
TERMINATED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Check Cap board of directors decision to stop all company activities including clinical trails
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of the study is to determine the ability of the C-Scan system to identify subjects who are at elevated risk for colon polyps. This will be evaluated by comparing the C-Scan data to colonoscopy data. The C-Scan procedure is therefore performed before the colonoscopy procedure, in order to compare these tests and evaluate the C-Scan system's effectiveness.
During the C-scan procedure, Subjects will be asked to come for an appointment in a clinic, during this appointment, the C-Scan Track will be placed on the participant's back. The participant will then be asked to swallow the C-Scan capsule whereafter they are free to continue their routine. Participants will start intake of fiber pills 5 days, and contrast agent 48 hours prior to C-Scan capsule ingestion and will continue intake up to the capsule's natural excretion.
A standard colonoscopy procedure will be performed within 60 days following C-Scan Cap ingestion.
During the C-scan procedure, Subjects will be asked to come for an appointment in a clinic, during this appointment, the C-Scan Track will be placed on the participant's back. The participant will then be asked to swallow the C-Scan capsule whereafter they are free to continue their routine. Participants will start intake of fiber pills 5 days, and contrast agent 48 hours prior to C-Scan capsule ingestion and will continue intake up to the capsule's natural excretion.
A standard colonoscopy procedure will be performed within 60 days following C-Scan Cap ingestion.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: