Colo-rectal CancerC-ScanNCT03735407
Safety,Usability and Compliance of Using C-Scan System for Providing Information on Colonic Polypoid Lesions and Masses
A study testing C-Scan procedure in people with Colo-rectal Cancer, run by Check-Cap Ltd. at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- C-Scan procedure
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 15 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female at the age of 40-80 years' old.
- Subject provided signed informed consent.
- Subject is willing and able to comply with the specified study requirements and follow-up evaluations, and can be contacted by telephone.
- Subjects able and agrees to undergo colonoscopy procedure.
- BMI > 22 and ≤ 35.
- Maximum body (abdominal) circumference < 120 cm.
- Has at least 3 bowel movements per week
- A colonoscopy procedure is pre-scheduled within 60 days
Who cannot join
- Known history of dysphagia or other swallowing disorders.
- History of the followings: Inflammatory Bowel Disease (IBD) including Crohn's disease or Ulcerative, Colitis, Meckel's Diverticulum, Bowen Hernia, known fistulas or strictures (doctors' discretion), or a history of small bowel obstruction.
- Known motility disorders:
- Chronic Constipation: less than 3 bowel movements/week, w/out the use of laxatives.
- 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.
- 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.
- 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.
- Concurrent participation in another clinical trial using any investigational drug or device.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the detailed description
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:
- Surveillance - Significant findings in previous optical colonoscopy
- Diagnostic - Polyps detected in virtual colonoscopy referred for polypectomy
- Diagnostic - Polyps detected in previous optical colonoscopy (community setting) referred for polypectomy
- Diagnostic - Positive FIT (Fecal Immunochemical Test)
- Diagnostic - one or more of the typical symptoms:
- abdominal pain
- Change in bowel habits
- Anemia or overt bleeding in stool
- Significant weight loss
- First degree relatives of CRC (Colo-Rectal Cancer)subjects Alternatively, average risk based on their age and demographics referred for screening for polyps
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
- Conditions
- Colo-rectal Cancer
- Being tested
- C-Scan procedure
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Scan procedureDevice
Also called data collection to improve the product's algorithm
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.
- 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,
| Study group | Role | What they receive |
|---|---|---|
| C-Scan procedure | Experimental | Subjects who are at high or at average risk for developing CRC and who are scheduled for optical colonoscopy will undergo C-Scan procedure Receives: Device: C-Scan procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Secondary outcomes (2)
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
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Feb 2019
- Primary completion1 Jan 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, Multi-center, Single-arm, safety study
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Check-Cap Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seth Gross, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735407
- Sponsor's protocol ID
- CL-SY-02-0096
- Acronym
- C-Scan
- Status last verified
- Aug 2023
- First submitted
- 5 Nov 2018
- Last updated
- 13 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03735407
- Acronym / sponsor ID
- C-Scan / CL-SY-02-0096
- Conditions
- Colo-rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Check-Cap Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Posted 13 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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:
- Surveillance - Significant findings in previous optical colonoscopy
- Diagnostic - Polyps detected in virtual colonoscopy referred for polypectomy
- Diagnostic - Polyps detected in previous optical colonoscopy (community setting) referred for polypectomy
- Diagnostic - Positive FIT (Fecal Immunochemical Test)
- Diagnostic - one or more of the typical symptoms:
- abdominal pain
- Change in bowel habits
- Anemia or overt bleeding in stool
- Significant weight loss
- First degree relatives of CRC (Colo-Rectal Cancer)subjects Alternatively, average risk based on their age and demographics referred for screening for polyps
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Multi-center, Single-arm, safety study
| Arm | Type | Receives |
|---|---|---|
| C-Scan procedure | Experimental | Device: C-Scan procedureSubjects who are at high or at average risk for developing CRC and who are scheduled for optical colonoscopy will undergo C-Scan procedure |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female at the age of 40-80 years' old.
- Subject provided signed informed consent.
- Subject is willing and able to comply with the specified study requirements and follow-up evaluations, and can be contacted by telephone.
- Subjects able and agrees to undergo colonoscopy procedure.
- BMI > 22 and ≤ 35.
Key exclusion criteria (8 listed)
- Known history of dysphagia or other swallowing disorders.
- History of the followings: Inflammatory Bowel Disease (IBD) including Crohn's disease or Ulcerative, Colitis, Meckel's Diverticulum, Bowen Hernia, known fistulas or strictures (doctors' discretion), or a history of small bowel obstruction.
- Known motility disorders:
- Chronic Constipation: less than 3 bowel movements/week, w/out the use of laxatives.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-Scan procedureAlso: data collection to improve the product's algorithmThe 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, | Device | C-Scan procedure |
Primary outcome
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.
2 secondary outcomes
Non-compliance Rate of Subjects (%)
Time frame: 6 months
To Evaluate Subject's Satisfaction
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth Gross principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-Scan procedure in people with Colo-rectal Cancer, run by Check-Cap Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Incidence of Device and Procedure Related Serious Adverse Events (SAE) (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.