Polypoid LesionsNCT02990715
Evaluation of Check-Cap C-Scan System in Providing Structural Information and Detection of Polypoid Lesions
A study testing C-Scan System in people with Polypoid Lesions, run by Check-Cap Ltd. at 3 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 FIT. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Polypoid Lesions
- 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
- 66 participants
- Where
- 3 sitesIsrael
- Study dates
- Nov 2016to 13 Sep 2017
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female at the age of 30-80 years old
- Subject provided signed informed consent
Who cannot join
- Patients 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, IBD, Meckel's Diverticulum, Bowen Hernia, Mega Colon, fistulas or other strictures (doctors' discretion).
- Subject with known motility disorder or Chronic Constipation
- 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 15Show 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)
- 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
3 sites in 1 country.
Israel3 sites
Emek Medical Center
Afula, Galilee
Rambam Medical Center
Haifa, North
Sourasky Medical Center
Tel Aviv, 64000
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 FIT.
Read the detailed description
The subject will be invited to come to the clinic to sign the ICF and other related documents. Then they'll ingest the capsule typically during the morning hours. The subjects will be connected to the C-Scan Track and 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/TV 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'.
Patients will be instructed to return the C-Scan Capsule and C-Scan Track to the clinic for analysis.
All subjects will be scheduled for optical colonoscopy to be performed within one month following capsule procedure.
C-Scan Procedure Analysis:
Two to three licensed gastroenterologist physicians, will be trained with reviewing and analyzing C-Scan System scans, to serve as independent reviewers. A reviewing forum consisting of at least one independent trained gastroenterologist physician and at least 2 expert Check-Cap reviewers that will jointly review all the cases. 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
- Polypoid Lesions
- Being tested
- C-Scan System
- Keywords
- average risk CRC screening, Non compliant patients for CRC screening, Counterindicated patients for colonoscopy
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
- 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 |
|---|---|---|
| Up to 45 subjects | Active comparator | Subjects with known polyp lesions≥10mm which were not removed because of poor preperation or the need to perform polypectomy at hospital will ingest the C-Scan cap and then will be schduled to polypectomy. The subjects will perform FIT test during the procedure and it will be compared with C-Scan System results. Receives: Device: C-Scan System |
| Up to 25 subjects | Experimental | Subjects who were reffered to screening colonoscopy as an average risk for CRC will ingest the C-Scan cap and then will be schduled to polypectomy. The subjects will perform FIT test during the procedure and it will be compared with C-Scan System results. 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 capsulle system in variuos segements of the colon as compared with the results indicated in the report of the follow-up colonoscopy
Measured: One year
Secondary outcomes (1)
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 variuos segements of the colon as
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 posted13 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion10 Sep 2017
- Study completion13 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polypoid LesionsStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Check-Cap Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex Ovadia, Study director, COO, VP R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990715
- Sponsor's protocol ID
- CL-SY-01-0093
- Status last verified
- Jan 2022
- First submitted
- 28 Nov 2016
- Last updated
- 19 Jan 2022
- Results posted
- No
- Individual data sharing
- No: Preliminary results will be presented in the European Gatro Conference UEGW on October 2017
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Check-Cap C-Scan System in Providing Structural Information and Detection of Polypoid Lesions
- ClinicalTrials.gov ID
- NCT02990715
- Acronym / sponsor ID
- CL-SY-01-0093
- Conditions
- Polypoid Lesions
- Keywords
- average risk CRC screening, Non compliant patients for CRC screening, Counterindicated patients for colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Check-Cap Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- 10 Sep 2017 (actual)
- Study completion
- 13 Sep 2017 (actual)
- First posted
- 13 Dec 2016 (estimated)
- 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 FIT.
Detailed description
The subject will be invited to come to the clinic to sign the ICF and other related documents. Then they'll ingest the capsule typically during the morning hours. The subjects will be connected to the C-Scan Track and 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/TV 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'.
Patients will be instructed to return the C-Scan Capsule and C-Scan Track to the clinic for analysis.
All subjects will be scheduled for optical colonoscopy to be performed within one month following capsule procedure.
C-Scan Procedure Analysis:
Two to three licensed gastroenterologist physicians, will be trained with reviewing and analyzing C-Scan System scans, to serve as independent reviewers. A reviewing forum consisting of at least one independent trained gastroenterologist physician and at least 2 expert Check-Cap reviewers that will jointly review all the cases. 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 |
|---|---|---|
| Up to 45 subjects | Active comparator | Device: C-Scan SystemSubjects with known polyp lesions≥10mm which were not removed because of poor preperation or the need to perform polypectomy at hospital will ingest the C-Scan cap and then will be schduled to polypectomy. The subjects will perform FIT test during the procedure and it will be compared with C-Scan System results. |
| Up to 25 subjects | Experimental | Device: C-Scan SystemSubjects who were reffered to screening colonoscopy as an average risk for CRC will ingest the C-Scan cap and then will be schduled to polypectomy. The subjects will perform FIT test during the procedure and it will be compared with C-Scan System results. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female at the age of 30-80 years old
- Subject provided signed informed consent
Key exclusion criteria (15 listed)
- Patients 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, IBD, Meckel's Diverticulum, Bowen Hernia, Mega Colon, fistulas or other strictures (doctors' discretion).
- Subject with known motility disorder or Chronic Constipation
- 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 capsule1. 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 | Up to 25 subjects, Up to 45 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 capsulle system in variuos segements of the colon as compared with the results indicated in the report of the follow-up colonoscopy
1 secondary outcome
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
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 19 Jan 2022.
- Individual participant dataSharing planned: No. Preliminary results will be presented in the European Gatro Conference UEGW on October 2017
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.
Alex Ovadia study director
COO, VP R&D
3 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 Polypoid Lesions, run by Check-Cap Ltd. at 3 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 2 inclusion and 15 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 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 19 Jan 2022.