An interventional study of C-Scan procedure in Colo-rectal Cancer, sponsored by Check-Cap Ltd.. Completed at 1 site in United States. Open to participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by Check-Cap Ltd. · Not applicable, Interventional, and Diagnostic
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
Overall Design: Up to 45 healthy subjects will participate in this study. Subjects to be enrolled in this study are indicated and scheduled to undergo optical colonoscopy based on the following symptoms or by being classified as higher than average risk based on one or more of the following:
Each subject will receive a comprehensive explanation regarding the study nature. During this process, and per ethical committee approval, subjects may be asked several questions (over the phone) regarding their medical background for preliminary assessment of eligibility. Once informed consent is obtained, a thorough evaluation of subject's eligibility will be performed based on inclusion / exclusion criteria.
Eligible subjects will be required to undergo FIT procedure, per package insert instructions, within pre-defined timelines. All subjects will be scheduled to undergo capsule procedure, to be followed later on with optical colonoscopy procedure.
One to three days following end of C-Scan procedure the subjects will be contacted by phone by the clinical coordinator to follow-up on the subject well-being. Same follow-up procedures will be applied one to three days following Optical Colonoscopy procedure. Medical history and concomitant medication information will be collected for all subjects.
Study Duration: The duration of study participation for each subject is expected to be approximately 8-10 weeks. The total study duration across all patients is expected to be approximately 6 months, dependent upon subject recruitment rate.
C-Scan Procedure: Subjects will be instructed to skip breakfast or lunch on the day of C-Scan Capsule ingestion to expedite gastric passage. Liquids are allowed.
The subjects will be connected to the C-Scan Track and after successful system's activation (BIT - built in test), the subject will be asked to ingest the C-Scan Capsule with some water, contrast media (GE Omnipaque 350) and non-soluble fiber, in the presence of a physician investigator or designee. The subject will also be provided with an RF watch. A representative of the sponsor will attend the ingestion procedure, as needed to assure proper activation.
Post ingestion, the subject will receive detailed instructions about the daily routine and activities as well as use of the RF watch and then will be discharged home with written instructions on the procedure Instructions for use (IFU), daily diary, FIT kit and capsule return kit.
FIT Procedure: All subjects will be required to perform FIT procedure using [OC-Light] FIT Kit prior or during the capsule procedure Capsule Return: Capsule procedure is completed upon capsule excretion or system auditory indication of 'End of Procedure'. Subjects will be instructed to inform the study coordinator or designee upon capsule excretion
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 45 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Check-Cap Ltd. is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:12.3 Exclusion Criteria
i. Chronic Constipation: less than 3 bowel movements/week, w/out the use of laxatives.
ii. Delayed gastric emptying. iii. Narcotic use d. Prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by physician discretion with the exception of appendectomy, cholecystectomy and hysterectomy e. Any condition believed to have an increased risk for capsule retention, strictures, bowel adhesion or other obstacles to free passage of the capsule (such as intestinal tumors, radiation enteritis) or incomplete colonoscopies (e.g. due to obstructions or NSAID enteropathy) as determined by physician discretion.
f. Has a cardiac device (e.g. pacemaker or ICD-Implantable Cardioverter Defibrillator) or any other active implanted device g. Known sensitivity to iodine, or with known kidney failure. h. Known condition which precludes compliance or is contraindicated with study and/or device instructions.
i. Has a Magnetic Image Resonance (MRI) procedure scheduled within 1 month j. Known condition of drug abuse and/or alcoholism. k. Women who are either pregnant or nursing at the time of screening (to be verified by urine or serum pregnancy test for woman of child- bearing potential who are not post-menopausal or undergone surgical sterilization.
l. Concurrent participation in another clinical trial using any investigational drug or device.
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,
Also known as: data collection to improve the product's algorithm
Number of Incidence of Device and Procedure Related Serious Adverse Events (SAE)
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.
Time frame: 6 Months
Non-compliance Rate of Subjects (%)
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
Time frame: 6 months
To Evaluate Subject's Satisfaction
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
Time frame: 8 weeks
| Milestone | C-Scan Procedure |
|---|---|
| Started | 40 |
| Completed | 40 |
| Not completed | 0 |
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.
| Participants | C-Scan Procedure |
|---|---|
| Number of Incidence of Device and Procedure Related Serious Adverse Events (SAE) | 0 |
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
| Participants | C-Scan Procedure |
|---|---|
| Non-compliance Rate of Subjects (%) | 40 |
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
| units on a scale | C-Scan Procedure |
|---|---|
| To Evaluate Subject's Satisfaction | 3.42 ± 1.25 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| C-Scan Procedure | 0/40 (0%) | 0/40 (0%) | 13/40 (32.5%) |
| Event | C-Scan Procedure |
|---|---|
| Abdominal pain, crampsGastrointestinal disorders | 8/40 |
| Skin irritationSkin and subcutaneous tissue disorders | 3/40 |
| diarrhea / soft stoolGastrointestinal disorders | 2/40 |
| Superficial PhlebitisBlood and lymphatic system disorders | 1/40 |
| NauseaGastrointestinal disorders | 1/40 |
| headacheNervous system disorders | 1/40 |
High risk and average risk for CRC
| Age, Continuous(years) | C-Scan Procedure |
|---|---|
| Mean | 52.9 ± 5.7 |
| Sex: Female, Male(Participants) | C-Scan Procedure |
|---|---|
| Female | 26 |
| Male | 14 |
| Race/Ethnicity, Customized(Participants) | C-Scan Procedure |
|---|---|
| race — American Indian or Alaska Native | 0 |
| race — Asian | 1 |
| race — Caucasian | 34 |
| race — African American | 3 |
| race — Unknown | 2 |
| race — More than one race | 0 |
| Belly Circumference(Centimeters) | C-Scan Procedure |
|---|---|
| Mean | 95.6 ± 11.7 |
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