Trial Outcomes & Findings for Safety,Usability and Compliance of Using C-Scan System for Providing Information on Colonic Polypoid Lesions and Masses (NCT NCT03735407)

Last Updated: 2023-09-13

Results Overview

The safety of the Check-Cap System will be evaluated by the incidence of device and procedure related Serious Adverse Events (SAE), as adjudicated by the Independent Physician Adjudicator.

Recruitment status

COMPLETED

Study phase

Target enrollment

45 participants

Primary outcome timeframe

6 Months

Results posted on

2023-09-13

Participant Flow

Participant milestones

Participant milestones
Measure	C-Scan Procedure Subjects who are at high or at average risk for developing CRC and who are scheduled for optical colonoscopy will undergo C-Scan procedure C-Scan procedure: The subjects will be connected to the C-Scan Track and after successful system's activation. The subject will be asked to ingest the C-Scan Capsule with some water, contrast media The subject will be required to ingest daily dose (3 X 15 ml) of contrast media. Capsule procedure is completed upon capsule excretion. o Collecting procedure related data: Technical performance in normal daily routine, Segmental transit time,Procedure duration, Number of Bowel movements , Similarity between C-Scan results and colonoscopy Etc,
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety,Usability and Compliance of Using C-Scan System for Providing Information on Colonic Polypoid Lesions and Masses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	C-Scan Procedure n=40 Participants Subjects who are at high or at average risk for developing CRC and who are scheduled for optical colonoscopy will undergo C-Scan procedure C-Scan procedure: The subjects will be connected to the C-Scan Track and after successful system's activation. The subject will be asked to ingest the C-Scan Capsule with some water, contrast media The subject will be required to ingest daily dose (3 X 15 ml) of contrast media. Capsule procedure is completed upon capsule excretion. o Collecting procedure related data: Technical performance in normal daily routine, Segmental transit time,Procedure duration, Number of Bowel movements , Similarity between C-Scan results and colonoscopy Etc,
Age, Continuous	52.9 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race/Ethnicity, Customized race · American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized race · Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized race · Caucasian	34 Participants n=5 Participants
Race/Ethnicity, Customized race · African American	3 Participants n=5 Participants
Race/Ethnicity, Customized race · Unknown	2 Participants n=5 Participants
Race/Ethnicity, Customized race · More than one race	0 Participants n=5 Participants
Belly Circumference	95.6 Centimeters STANDARD_DEVIATION 11.7 • n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

The safety of the Check-Cap System will be evaluated by the incidence of device and procedure related Serious Adverse Events (SAE), as adjudicated by the Independent Physician Adjudicator.

Outcome measures

Outcome measures
Measure	C-Scan Procedure n=40 Participants Subjects who are at high or at average risk for developing CRC and who are scheduled for optical colonoscopy will undergo C-Scan procedure C-Scan procedure: The subjects will be connected to the C-Scan Track and after successful system's activation. The subject will be asked to ingest the C-Scan Capsule with some water, contrast media The subject will be required to ingest daily dose (3 X 15 ml) of contrast media. Capsule procedure is completed upon capsule excretion. o Collecting procedure related data: Technical performance in normal daily routine, Segmental transit time,Procedure duration, Number of Bowel movements , Similarity between C-Scan results and colonoscopy Etc,
Number of Incidence of Device and Procedure Related Serious Adverse Events (SAE)	0 Participants

SECONDARY outcome

Timeframe: 6 months

Subject compliance will be assessed by \- Non-compliance rate throughout the study via diary completion by the subject Specific questionnaire. completed by remote subject monitoring (via telephone) The rate will be measured in a percentage scale (1-100%) Score less then 50% will be considered as a compliance failure

Outcome measures

Outcome measures
Measure	C-Scan Procedure n=40 Participants Subjects who are at high or at average risk for developing CRC and who are scheduled for optical colonoscopy will undergo C-Scan procedure C-Scan procedure: The subjects will be connected to the C-Scan Track and after successful system's activation. The subject will be asked to ingest the C-Scan Capsule with some water, contrast media The subject will be required to ingest daily dose (3 X 15 ml) of contrast media. Capsule procedure is completed upon capsule excretion. o Collecting procedure related data: Technical performance in normal daily routine, Segmental transit time,Procedure duration, Number of Bowel movements , Similarity between C-Scan results and colonoscopy Etc,
Non-compliance Rate of Subjects (%)	40 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: The C-scan questionnaire was completed following the excretion of the C-Scan capsule. Forty subjects completed the questionnaire

Subject satisfaction will be established by: Designated questionnaire that focuses on patient's impressions regarding tolerance and potential safety concerns, which will be provided to the subjects after the C-Scan procedure and after the colonoscopy procedure. Acceptance criteria was defined as average score \>3.5 (1- low satisfaction to 5- high satisfaction), which represent high satisfaction with the safety and tolerance of the C-scan system. Comparing patient's satisfaction with C-Scan procedure and colonoscopy procedure

Outcome measures

Outcome measures
Measure	C-Scan Procedure n=40 Participants Subjects who are at high or at average risk for developing CRC and who are scheduled for optical colonoscopy will undergo C-Scan procedure C-Scan procedure: The subjects will be connected to the C-Scan Track and after successful system's activation. The subject will be asked to ingest the C-Scan Capsule with some water, contrast media The subject will be required to ingest daily dose (3 X 15 ml) of contrast media. Capsule procedure is completed upon capsule excretion. o Collecting procedure related data: Technical performance in normal daily routine, Segmental transit time,Procedure duration, Number of Bowel movements , Similarity between C-Scan results and colonoscopy Etc,
To Evaluate Subject's Satisfaction	3.42 units on a scale Standard Deviation 1.25

Adverse Events

C-Scan Procedure

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	C-Scan Procedure n=40 participants at risk Subjects who are at high or at average risk for developing CRC and who are scheduled for optical colonoscopy will undergo C-Scan procedure C-Scan procedure: The subjects will be connected to the C-Scan Track and after successful system's activation. The subject will be asked to ingest the C-Scan Capsule with some water, contrast media The subject will be required to ingest daily dose (3 X 15 ml) of contrast media. Capsule procedure is completed upon capsule excretion. o Collecting procedure related data: Technical performance in normal daily routine, Segmental transit time,Procedure duration, Number of Bowel movements , Similarity between C-Scan results and colonoscopy Etc,
Gastrointestinal disorders Abdominal pain, cramps	20.0% 8/40 • Number of events 8 • 6 months Adverse event were reported to the study nurse and or study PI
Skin and subcutaneous tissue disorders Skin irritation	7.5% 3/40 • Number of events 3 • 6 months Adverse event were reported to the study nurse and or study PI
Gastrointestinal disorders diarrhea / soft stool	5.0% 2/40 • Number of events 2 • 6 months Adverse event were reported to the study nurse and or study PI
Blood and lymphatic system disorders Superficial Phlebitis	2.5% 1/40 • Number of events 1 • 6 months Adverse event were reported to the study nurse and or study PI
Gastrointestinal disorders Nausea	2.5% 1/40 • Number of events 1 • 6 months Adverse event were reported to the study nurse and or study PI
Nervous system disorders headache	2.5% 1/40 • Number of events 1 • 6 months Adverse event were reported to the study nurse and or study PI

Additional Information

Clinical Director

CheckCap

Phone: 972-4-8303401

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All proposed publications and presentations by the Investigator, the Institution or their personnel and associates, resulting from or relating to the Study, must be submitted to the Company for review and approval at least forty five (45) days prior to submission for publication or presentation.
Publication restrictions are in place

Restriction type: OTHER