Ignite Creation Date:
2024-05-06 @ 1:18 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03989180
Status:
COMPLETED
Last Update Posted:
2022-02-17
First Post:
2019-02-10
Brief Title:
Development Study of Check-Cap Imaging System in Healthy Volunteers
Sponsor:
Check-Cap Ltd
Organization:
Check-Cap Ltd
Study Overview
Official Title:
Development Study of Check-Cap Imaging System in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the performance of Check-Cap Imaging System in healthy volunteers in a variety of operating scenarios
The Back recorder unit is the primary module for evaluation The participants DO NOT ingest a capsule and the capsules do not have any radioactive source
The Back recorder unit is the primary module for evaluation The participants DO NOT ingest a capsule and the capsules do not have any radioactive source
Detailed Description:
1 st visit - Subjects will be referred to the study by an advertisement in the local media
The subjects will receive a preliminary explanation about the study procedure and required activities If the subjects agree to participate in the study will be asked to sign the ICF
Subjects will be screened for eligibility according to the inclusionexclusion criteria
The date for their participation will be coordinated at their convenience
2 nd visit - Subject will arrive to the company RD lab and will receive detailed introduction about the procedure and instruction for the daily activities
The total duration of Check-Cap Imaging System study for each subject is up to 4 days
Subjects will receive detailed instructions verbally and written about the normal operation of the C-Scan System and how to handle it during normal daily routine They will be asked to document all their daily activity in a personal diary
The C-Scan Track will be attached to their lower back to test its functionality and the capsule will be attached to their abdomen to test the effect on data transmission during daily activities
The interference of the back recorder with the cloths belt bra etc will be monitored for any discomfort
Subjects will be asked to complete a personal diary which documents the time and duration of significant activities during the procedure such as meal times sleeping times physical activities etc
Some subjects will be instructed to be stationary during short sessions 10-20-30 min and may read watch TV or use the Internet The localization data will be collected on a dedicated portable computer via these detectors
The monitoring routine for each subject will include but not limited to the following parameters
The well-being of the subject and hisher daily routine work meals driving public transportation mild sport shower sleep other activities
Inquiries about any discomfort caused by the recorder
Inquiries about any discomfort or skin irritation caused by the patches
Inquiries about the function of the recorder as indicated by the recorder visual indicators
Ease of operation of the push buttons positioned on the recorder reaching to the lower back with wout direct vision mirror
Responding to auditory and visual indicators position on the recorder
Some subjects will be asked to continue carrying the back recorder system for few more days in order to evaluate the effects of the system on their daily activities
A subjective questionnaire will be filled by the subjects following each phase of the evaluation in order to solicit immediate feedback regarding any discomfort or complaint During the current development study the plan is to simulate some of these scenarios and evaluate the functionality of the back-recorder and communication with the capsule
Subjects will continue their daily routine work sleep shower driving in car or public transportation sit stand walk
Subjects should refrain from active sport such as jogging physical exercise in the gym swimming sauna any ball-games skiing etc
Subjects should refrain from Flights boat trips or long train travels during the monitoring procedure
Subjects should try and stay away from areas with high electromagnetic fields such as High voltage elect Poles transformation station radio and TV transmitter station etc
Subjects should not be examined by CT or MRI unless it is an emergency
Subjects who are working in an area with high electromagnetic field should not be examined by the capsule
The subjects will receive a preliminary explanation about the study procedure and required activities If the subjects agree to participate in the study will be asked to sign the ICF
Subjects will be screened for eligibility according to the inclusionexclusion criteria
The date for their participation will be coordinated at their convenience
2 nd visit - Subject will arrive to the company RD lab and will receive detailed introduction about the procedure and instruction for the daily activities
The total duration of Check-Cap Imaging System study for each subject is up to 4 days
Subjects will receive detailed instructions verbally and written about the normal operation of the C-Scan System and how to handle it during normal daily routine They will be asked to document all their daily activity in a personal diary
The C-Scan Track will be attached to their lower back to test its functionality and the capsule will be attached to their abdomen to test the effect on data transmission during daily activities
The interference of the back recorder with the cloths belt bra etc will be monitored for any discomfort
Subjects will be asked to complete a personal diary which documents the time and duration of significant activities during the procedure such as meal times sleeping times physical activities etc
Some subjects will be instructed to be stationary during short sessions 10-20-30 min and may read watch TV or use the Internet The localization data will be collected on a dedicated portable computer via these detectors
The monitoring routine for each subject will include but not limited to the following parameters
The well-being of the subject and hisher daily routine work meals driving public transportation mild sport shower sleep other activities
Inquiries about any discomfort caused by the recorder
Inquiries about any discomfort or skin irritation caused by the patches
Inquiries about the function of the recorder as indicated by the recorder visual indicators
Ease of operation of the push buttons positioned on the recorder reaching to the lower back with wout direct vision mirror
Responding to auditory and visual indicators position on the recorder
Some subjects will be asked to continue carrying the back recorder system for few more days in order to evaluate the effects of the system on their daily activities
A subjective questionnaire will be filled by the subjects following each phase of the evaluation in order to solicit immediate feedback regarding any discomfort or complaint During the current development study the plan is to simulate some of these scenarios and evaluate the functionality of the back-recorder and communication with the capsule
Subjects will continue their daily routine work sleep shower driving in car or public transportation sit stand walk
Subjects should refrain from active sport such as jogging physical exercise in the gym swimming sauna any ball-games skiing etc
Subjects should refrain from Flights boat trips or long train travels during the monitoring procedure
Subjects should try and stay away from areas with high electromagnetic fields such as High voltage elect Poles transformation station radio and TV transmitter station etc
Subjects should not be examined by CT or MRI unless it is an emergency
Subjects who are working in an area with high electromagnetic field should not be examined by the capsule
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None