High Risk (Above Average) SubjectsNCT03356002
Evaluation of C-Scan System in Providing Structural Information and Detection of Polypoid Lesions in High Risk Subjects
A study testing C-Scan System in people with High Risk (Above Average) Subjects and Non Compliant Patients for Colo Rectal Cancer [CRC] Screening, run by Check-Cap Ltd. at 7 sites in Israel.
Trial summary
The purpose of this study is to establish the efficacy of Check-Cap's C-Scan System in providing structural information on colonic polypoid lesions and masses, as an adjacent tool to Feacal Immunochemical Test [FIT] in high risk subjects Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- High Risk (Above Average) Subjects, Non Compliant Patients for Colo Rectal Cancer [CRC] Screening, Counterindicated Patients for Colonoscopy
- What is being tested?
- C-Scan System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 7 sitesIsrael
- Study dates
- 28 Jan 2018to 26 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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 test
- Diagnostic - one or more of the typical symptoms:
- abdominal pain Change in bowel habits Anemia or overt bleeding in stool Significant weight loss
- 1st degree relatives of CRC subjects Alternatively average risk based on their age and demographics referred for screening for polyps.
Who cannot join
- Subjects with advanced cancer or other life threatening diseases or conditions
- Subject with known history of dysphagia or other swallowing disorders
- Subject with known history of GI disease or symptoms, such as: Crohn's disease, Colitis, Inflammatory Bowel Disease [IBD], Meckel's Diverticulum, Bowen Hernia, Mega Colon, fistulas or other strictures (doctors' discretion).
- Subject with known motility disorder or Chronic Constipation (less than 3 bowel movements/week)
- Subject with known delayed gastric emptying
- Subject with prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by physician discretion
Show all 16Show fewer
- Subject with any condition believed to have an increased risk for capsule retention such as intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy, as determined by physician discretion
- Subject with a cardiac pacemaker or other implanted electro medical device
- Subjects with known sensitivity to iodine, or with kidney failure
- Subjects with morbid obesity (BMI > 40)
- Subjects with belly / girth circumference > 125 cm
- Subject with any known condition which precludes compliance with study and/or device instructions
- Subject with known condition of drug abuse and/or alcoholism
- Subject who is unable to undergo colonoscopy or bowel preparation necessary for colonoscopy (based on previous attempts or self-declaration)
- Women who are either pregnant or nursing at the time of screening (to be verified by test in case of woman of child-bearing potential that do not practice medically acceptable methods of contraception)
- Concurrent participation in another clinical trial using any investigational drug or device
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Israel7 sites
Haemek Medical Center
Afula
Soroka Medical Center
Beersheba
Rambam Medical Center
Haifa, North
Bnai-Zion Medical Center
Haifa
Meir Medical Center
Kfar Saba
Laniado Medical Center
Netanya
Tel Aviv Sorasky Medical Center
Tel Aviv
About this study
The purpose of this study is to establish the efficacy of Check-Cap's C-Scan System in providing structural information on colonic polypoid lesions and masses, as an adjacent tool to Feacal Immunochemical Test [FIT] in high risk subjects
Read the detailed description
The subject will be invited to come to the clinic to sign the Informed Consent Form [ICF] and other related .
The subjects will be connected to the C-Scan Track and following system's activation the subject will be asked to ingest the C-Scan Capsule with some water and contrast media, in the presence of a physician.
Post ingestion, the subject will be discharged home with clear instructions on the procedure. The subject should avoid intensive physical exercise during procedure or any extreme activities. The subject should make an effort to stay at home or other familiar surroundings, and may continue daily activities such mobile/computer/Television use, shower, sleep or eat. Details on allowed and restricted activities are listed in app. 4 The subject will be required to ingest daily dose (3 X 15-17ml) of contrast media, to be consumed three times per day with normal diet. Also on a need based the subject would be provided with laxadine (5 mg tablets) to be ingested according to the doctor recommendation.
During capsule procedure the subjects will be contacted by phone several times daily by the site clinical study team (or by dedicated external trained medical personnel), to assure the subjects well-being and to monitor for any change or discomfort and for procedure progress. Subjects may be also monitored by the technical team (either at home or at the clinic), who may need to examine the system or inquire the subjects about the system visual/auditory indicators.
The subjects will be provided with a dedicated capsule collection kit, to assist the subjects in collecting the capsule. Subjects will be instructed to retrieve the capsule upon excretion.
Capsule procedure is completed upon capsule excretion or system vibro/auditory indication of 'End of Procedure'.
Once the procedure is completed, The C-Scan Capsule and C-Scan Track will be collected from the subject and returned to the sponsor's lab for preliminary analysis.
All subjects will be scheduled for optical colonoscopy to be performed within one month following capsule procedure.
C-Scan Procedure Analysis:
Several (3-6) licensed gastroenterologist physicians, will be trained with reviewing and analyzing C-Scan System scans, to serve as independent reviewers. Each case will be reviewed by 3 independant reviewers. The reviewing forum will be blinded to the FIT and colonoscopy results of the examined patients. Analysis will be performed on a per patient basis for the existence or non-existence of a finding that may be a polyp. This per patient finding will be compared with the FIT, and a colonoscopy will be performed for verification.
- Conditions
- High Risk (Above Average) Subjects, Non Compliant Patients for Colo Rectal Cancer [CRC] Screening, Counterindicated Patients for Colonoscopy
- Being tested
- C-Scan System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Scan SystemDevice
Also called Colon capsule
Each subject will ingest the capsule within 30 days prior to colonoscopy. The results of the C-Scan review will be compared to the findings of colonoscopy.
- To establish the efficacy of C-Scan Capsule System and FIT in detecting patients with polypoid lesions ≥ 10mm, compared with Optical Colonoscopy
- To evaluate the safety of the C-Scan Capsule System procedure
| Study group | Role | What they receive |
|---|---|---|
| High risk subjects | Active comparator | Each subject will ingest the C-Scan System capsule within 30 days prior to colonoscopy. The results of the C-Scan review will be compared to the findings of colonoscopy.
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:
c. Surveillance - Significant findings in previous optical colonoscopy d. Diagnostic - Polyps detected in virtual colonoscopy referred for polypectomy e. Diagnostic - Polyps detected in previous optical colonoscopy (community setting) referred for polypectomy f. Diagnostic - Positive FIT test g. Diagnostic - one or more of the typical symptoms: Receives: Device: C-Scan System |
| Average risk | Experimental | Each subject will ingest the C-Scan System capsule within 30 days prior to colonoscopy. The results of the C-Scan review will be compared to the findings of colonoscopy.
Average risk based on their age and demographics referred for screening for polyps. Receives: Device: C-Scan System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of C-Scan Capsule System in detecting per segment polypoid lesions 10 mm and up as compared with Colonoscopy
Number of polyps detected by the capsule system in various segments of the colon as compared with the results indicated in the report of the follow-up colonoscopy
Measured: One year
Secondary outcomes (3)
Sensitivity and specificity of C-Scan Capsule System in detecting patients with polypoid lesions 6≤x≤9 mm, compared with Optical Colonoscopy
Number of polyp specificity of C-Scan Capsule System in detecting patients with polypoid lesions 6≤x≤9 mm detected by the capsule system in various segments of the colon as
Measured: One year
Calculation of the score of the C-Scan system to generate a 3D model of the colon
Using the C-Scan View work station, the review will determine the score, on a scale of 1-10, the completeness of the colon model in each case. The average and Standard Deviation [SD] of all results will be calculated
Measured: One year
Quantify the variance of the Interpretation of the data from the C-Scan System between the reviewers
Each case will be reviewed by 3 independent reviewers who are blinded to the results of the FIT and colonoscopy. Calculate the variance between the results of each reviewer
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start28 Jan 2018
- Primary completion26 Jan 2020
- Study completion26 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk (Above Average) SubjectsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Check-Cap Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boaz Shpigelman, Study director, VP R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356002
- Sponsor's protocol ID
- CL-SY-01-0094
- Status last verified
- Feb 2020
- First submitted
- 20 Nov 2017
- Last updated
- 7 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Preliminary results will be presented in the European Gastro Week Conference \[UEGW\] on October 2018
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of C-Scan System in Providing Structural Information and Detection of Polypoid Lesions in High Risk Subjects
- ClinicalTrials.gov ID
- NCT03356002
- Acronym / sponsor ID
- CL-SY-01-0094
- Conditions
- High Risk (Above Average) Subjects, Non Compliant Patients for Colo Rectal Cancer [CRC] Screening, Counterindicated Patients for Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Check-Cap Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jan 2018 (actual)
- Primary completion
- 26 Jan 2020 (actual)
- Study completion
- 26 Jan 2020 (actual)
- First posted
- 29 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to establish the efficacy of Check-Cap's C-Scan System in providing structural information on colonic polypoid lesions and masses, as an adjacent tool to Feacal Immunochemical Test [FIT] in high risk subjects
Detailed description
The subject will be invited to come to the clinic to sign the Informed Consent Form [ICF] and other related .
The subjects will be connected to the C-Scan Track and following system's activation the subject will be asked to ingest the C-Scan Capsule with some water and contrast media, in the presence of a physician.
Post ingestion, the subject will be discharged home with clear instructions on the procedure. The subject should avoid intensive physical exercise during procedure or any extreme activities. The subject should make an effort to stay at home or other familiar surroundings, and may continue daily activities such mobile/computer/Television use, shower, sleep or eat. Details on allowed and restricted activities are listed in app. 4 The subject will be required to ingest daily dose (3 X 15-17ml) of contrast media, to be consumed three times per day with normal diet. Also on a need based the subject would be provided with laxadine (5 mg tablets) to be ingested according to the doctor recommendation.
During capsule procedure the subjects will be contacted by phone several times daily by the site clinical study team (or by dedicated external trained medical personnel), to assure the subjects well-being and to monitor for any change or discomfort and for procedure progress. Subjects may be also monitored by the technical team (either at home or at the clinic), who may need to examine the system or inquire the subjects about the system visual/auditory indicators.
The subjects will be provided with a dedicated capsule collection kit, to assist the subjects in collecting the capsule. Subjects will be instructed to retrieve the capsule upon excretion.
Capsule procedure is completed upon capsule excretion or system vibro/auditory indication of 'End of Procedure'.
Once the procedure is completed, The C-Scan Capsule and C-Scan Track will be collected from the subject and returned to the sponsor's lab for preliminary analysis.
All subjects will be scheduled for optical colonoscopy to be performed within one month following capsule procedure.
C-Scan Procedure Analysis:
Several (3-6) licensed gastroenterologist physicians, will be trained with reviewing and analyzing C-Scan System scans, to serve as independent reviewers. Each case will be reviewed by 3 independant reviewers. The reviewing forum will be blinded to the FIT and colonoscopy results of the examined patients. Analysis will be performed on a per patient basis for the existence or non-existence of a finding that may be a polyp. This per patient finding will be compared with the FIT, and a colonoscopy will be performed for verification.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High risk subjects | Active comparator | Device: C-Scan SystemEach subject will ingest the C-Scan System capsule within 30 days prior to colonoscopy. The results of the C-Scan review will be compared to the findings of colonoscopy. 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: c. Surveillance - Significant findings in previous optical colonoscopy d. Diagnostic - Polyps detected in virtual colonoscopy referred for polypectomy e. Diagnostic - Polyps detected in previous optical colonoscopy (community setting) referred for polypectomy f. Diagnostic - Positive FIT test g. Diagnostic - one or more of the typical symptoms: |
| Average risk | Experimental | Device: C-Scan SystemEach subject will ingest the C-Scan System capsule within 30 days prior to colonoscopy. The results of the C-Scan review will be compared to the findings of colonoscopy. Average risk based on their age and demographics referred for screening for polyps. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female at the age of 40-80 years old
- Subject provided signed informed consent
- 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 test
- abdominal pain Change in bowel habits Anemia or overt bleeding in stool Significant weight loss
Key exclusion criteria (16 listed)
- Subjects with advanced cancer or other life threatening diseases or conditions
- Subject with known history of dysphagia or other swallowing disorders
- Subject with known history of GI disease or symptoms, such as: Crohn's disease, Colitis, Inflammatory Bowel Disease [IBD], Meckel's Diverticulum, Bowen Hernia, Mega Colon, fistulas or other strictures (doctors' discretion).
- Subject with known motility disorder or Chronic Constipation (less than 3 bowel movements/week)
- Subject with known delayed gastric emptying
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 SystemAlso: Colon capsuleEach subject will ingest the capsule within 30 days prior to colonoscopy. The results of the C-Scan review will be compared to the findings of colonoscopy. 1. To establish the efficacy of C-Scan Capsule System and FIT in detecting patients with polypoid lesions ≥ 10mm, compared with Optical Colonoscopy 2. To evaluate the safety of the C-Scan Capsule System procedure | Device | Average risk, High risk subjects |
Primary outcome
Sensitivity and specificity of C-Scan Capsule System in detecting per segment polypoid lesions 10 mm and up as compared with Colonoscopy
Time frame: One year
Number of polyps detected by the capsule system in various segments of the colon as compared with the results indicated in the report of the follow-up colonoscopy
3 secondary outcomes
Sensitivity and specificity of C-Scan Capsule System in detecting patients with polypoid lesions 6≤x≤9 mm, compared with Optical Colonoscopy
Time frame: One year
Calculation of the score of the C-Scan system to generate a 3D model of the colon
Time frame: One year
Quantify the variance of the Interpretation of the data from the C-Scan System between the reviewers
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: No. Preliminary results will be presented in the European Gastro Week Conference [UEGW] on October 2018
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.
Boaz Shpigelman study director
VP R&D
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-Scan System in people with High Risk (Above Average) Subjects and Non Compliant Patients for Colo Rectal Cancer [CRC] Screening, run by Check-Cap Ltd. at 7 sites in Israel.
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 7 inclusion and 16 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 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity and specificity of C-Scan Capsule System in detecting per segment polypoid lesions 10 mm and up as compared with Colonoscopy (time frame: One year). 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 7 Feb 2020.