Safety,Usability and Compliance of Using C-Scan System for Providing Information on Colonic Polypoid Lesions and Masses (C-Scan)
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|ClinicalTrials.gov Identifier: NCT03735407|
Recruitment Status : Completed
First Posted : November 8, 2018
Last Update Posted : April 8, 2020
Protocol Title: Evaluation of safety, usability and subject compliance while using Check- Cap's C-Scan System for providing structural information on colonic polypoid lesions and masses Study Design: Prospective, Multi-center, Single-arm, safety study Purpose: To demonstrate the safety of the Check-Cap C-Scan System Study Centers: Up to two (2) centers located in the United States Number of Participants: 45 healthy subjects Investigational Device: Check-Cap's C-Scan System comprises C-Scan Capsule, C-Scan Track and C-Scan View.
Primary Objective: To evaluate the safety of the Check-Cap C-Scan System Secondary Objectives: a. To evaluate subject's compliance b. To evaluate subject's satisfaction c. To collect data to improve the product's algorithm
|Condition or disease||Intervention/treatment||Phase|
|Colo-rectal Cancer||Device: C-Scan procedure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, Multi-center, Single-arm, safety study|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Safety, Usability and Subject Compliance While Using Check- Cap's C-Scan System for Providing Structural Information on Colonic Polypoid Lesions and Masses|
|Actual Study Start Date :||February 1, 2019|
|Actual Primary Completion Date :||January 1, 2020|
|Actual Study Completion Date :||February 15, 2020|
Experimental: 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
Device: 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,
Other Name: data collection to improve the product's algorithm
- Number of incidence of device and procedure related Serious Adverse Events (SAE) [ Time Frame: 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.
- Non-compliance rate of subjects (%) [ Time Frame: 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
- To evaluate subject's satisfaction [ Time Frame: 8 weeks ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735407
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Seth Gross||NYU Langone Health|