Ignite Creation Date:
2024-05-06 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05271656
Status:
TERMINATED
Last Update Posted:
2023-07-28
First Post:
2022-02-15
Brief Title:
Evaluation of C-Scan Capsule in Identifying Subjects With Elevated Risk of Colon Polyps
Sponsor:
Check-Cap Ltd
Organization:
Check-Cap Ltd
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 systems 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 participants 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 capsules 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 participants 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 capsules 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:
None
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?:
None