ColoRectal CancerNCT01458925
Feasibility of Check-Cap's P1 Capsule System Screening
A study testing The P1 Check-Cap capsule in people with ColoRectal Cancer and Colonic Polyps, run by Check-Cap Ltd. at 1 site in Israel.
Trial summary
Prospective, Single arm, Multi-Center 1. To establish the safety and preliminary efficacy of the Check-Cap System in patients with negative FOBT (Fecal Occult Blood Test) 2. To collect data about the overall imaging of the colon internal surface during the passage of the capsule 3. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- ColoRectal Cancer, Colonic Polyps
- What is being tested?
- The P1 Check-Cap capsule
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Nov 2011to 2 Jan 2019
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between 40 and 75 years of age.
- Subject is generally in good health.
- Subject is ready to undergo FOBT or FIT and Colonoscopy.
- Subject agrees to sign the informed consent.
Who cannot join
- Subject has any known Gastro Intestinal [GI] related symptoms, complaints or GI diseases.
- Subject is contraindicated from performing colon cleansing (bowel prep.)
- Subject has cancer or other life threatening diseases or conditions.
- Female subject is pregnant.
- Subject underwent any abdominal surgery.
- Morbid Obese (BMI > 40) subject.
Show all 9Show fewer
- Subject has known drug abuse or alcoholism problem.
- Subject is under custodial care.
- Subject is currently or will be participating in other clinical study within 30 days prior to Check-Cap procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Multi-center Prospective Study of Check-Cap's P1 Capsule System in Patients Eligible for ColoRectal Cancer [CRC] Screening
Prospective, Single arm, Multi-Center
- To establish the safety and preliminary efficacy of the Check-Cap System in patients with negative FOBT (Fecal Occult Blood Test)
- To collect data about the overall imaging of the colon internal surface during the passage of the capsule
- To develop a correlation map between the imaging of the polyps by optical colonoscopy vs. the images of same polyps by the Check-Cap capsule vs. the imaging of same polyps by CT Colonography [CTC] (in patients which were referred after positive CTC examination)
Read the detailed description
Study Title:
Outside USA [OUS] Pilot Multi-center prospective feasibility study
Objectives:
Primary:
To establish the safety and preliminary efficacy of the Check-Cap System in patients with negative FOBT (Fecal Occult Blood Test) or FIT
Secondary:
- To evaluate the safety of the device in terms of total and segmental transit time and to study the effect of the presence of polyps and variable colon dimensions on these parameters.
- To monitor the functionality of the activation mechanism and of the scanning circuitry (transmitter detectors).
- To collect data about the overall imaging of the colon internal surface during the passage of the capsule
- To develop a correlation map between the imaging of the polyps by optical colonoscopy vs. the images of same polyps by the Check-Cap capsule vs. the imaging of same polyps by CT Colonography (in patients which were referred after positive CTC examination)
- To estimate the total radiation exposure to each patient.
- To measure the distribution of the contrast material within the colon.
Design:
Prospective, Single arm, Multi-Center
Patient population:
Group A - First in Man:
Male and female subjects older than 40 and younger than 75 years old that are eligible for CRC screening and meet the eligibility criteria for study enrollment.
The study population will be enriched with up to 45 patients with known polyps detected by CTC or colonoscopy, in addition to 15 patient of the device's normal cohort.
All patients that are eligible for enrollment in the study will be tested by FOBT (Fecal Occult Blood Test) After the Capsule test, they will be referred for optical colonoscopy as part of the study
Group B - CE Pilot:
Male and female subjects older than 45 and younger than 75 years old that are eligible for CRC screening and meet the eligibility criteria for study enrollment.
All patients that are eligible for enrollment in the study will be tested by FIT ,. After the Capsule test they will be referred for optical colonoscopy Consenting patients with negative FIT testing scheduled for clinically-indicated optical colonoscopy without contraindication to either Check-Cap System imaging or optical colonoscopy, and able to undergo the bowel preparation necessary for optical colonoscopy.
Sample Size:
Total of 100 patients in both groups: A:3-5 + B: 55-57 subjects.
Study Procedure:
- st visit - recruitment and screening meeting with the Principal Investigator [PI]. Subject will receive the FIT test kit with detailed instructions for executing the test.
- nd visit - The FIT kits will be analyzed in order to diagnose the presence of blood in the stool. If the bowel log form is complete and the bowel frequency is not less than once per 2 days the subject will be asked to sign the Informed Consent Form [ICF] for ingesting the capsule.
- rd visit - Subject will ingest the capsule and continue ingestion of contrast material.
- th visit - Subjects will return to the PI with the excreted capsule which is expected within 24-100 hours after ingestion.
- th visit - All patients will undergo standard bowel preparation and optical colonoscopy between 10 and 30 days following imaging with the Check-Cap System.
- Conditions
- ColoRectal Cancer, Colonic Polyps
- Being tested
- The P1 Check-Cap capsule
- Keywords
- Colorectal cancer, Colonic polyps
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The P1 Check-Cap capsuleDevice
The P1 Check-Cap capsule will be ingested by all participants. After the Capsule test, they will be referred for optical colonoscopy as part of the study
| Study group | Role | What they receive |
|---|---|---|
| P1 capsule and screening Cscopy | Other | Male and female patients older than 40 and younger than 75 years old who volunteer for the experiment and qualify with the inclusion / Exclusion criteria.
The P1 Check-Cap capsule will be ingested by all participants. After the Capsule test, they will be referred for optical colonoscopy as part of the study Receives: Device: The P1 Check-Cap capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety - transit time (less than 300 hours)
To evaluate the safety of the device in terms of total and segmental transit time and to study the effect of the presence of polyps and variable colon dimensions on these parameters. The measured effect is the correlation of the capsule transit time (hours) with the number of polyps and their size (in mm).
Measured: after each subject (once the capsule in excreted, typically 30-80 hours)
Secondary outcomes (1)
Colon Capsule correlation map (Empirical, qualitative)
To develop a correlation map between the imaging of the polyps by optical colonoscopy vs. the images of same polyps by the Check-Cap capsule vs. the imaging of same polyps by CT Colonography (in patients which were referred after positive CTC examination). No quantitative data here, only qualitative comparison between the scanning of the inner surface of the colon by the 3 independedt imaging modalities. No statistical plan or sample size justification would be provided, as is convention for pilot studies.
Measured: end of study (anticipted within 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study start20 Nov 2011
- Primary completion16 Sep 2018
- Study completion2 Jan 2019
Why it stopped: All trials ojectives were met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColoRectal 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
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Check-Cap Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoav Kimchy, Ph.D.,, Study chair, yoav.kimchy@check-cap.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458925
- Sponsor's protocol ID
- CL-SY-01-0091
- Status last verified
- Jan 2019
- First submitted
- 21 Oct 2011
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Multi-center Prospective Study of Check-Cap's P1 Capsule System in Patients Eligible for ColoRectal Cancer [CRC] Screening
- ClinicalTrials.gov ID
- NCT01458925
- Acronym / sponsor ID
- CL-SY-01-0091
- Conditions
- ColoRectal Cancer, Colonic Polyps
- Keywords
- Colorectal cancer, Colonic polyps
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: All trials ojectives were met
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Check-Cap Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2011 (actual)
- Primary completion
- 16 Sep 2018 (actual)
- Study completion
- 2 Jan 2019 (actual)
- First posted
- 25 Oct 2011 (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.
Prospective, Single arm, Multi-Center
- To establish the safety and preliminary efficacy of the Check-Cap System in patients with negative FOBT (Fecal Occult Blood Test)
- To collect data about the overall imaging of the colon internal surface during the passage of the capsule
- To develop a correlation map between the imaging of the polyps by optical colonoscopy vs. the images of same polyps by the Check-Cap capsule vs. the imaging of same polyps by CT Colonography [CTC] (in patients which were referred after positive CTC examination)
Detailed description
Study Title:
Outside USA [OUS] Pilot Multi-center prospective feasibility study
Objectives:
Primary:
To establish the safety and preliminary efficacy of the Check-Cap System in patients with negative FOBT (Fecal Occult Blood Test) or FIT
Secondary:
- To evaluate the safety of the device in terms of total and segmental transit time and to study the effect of the presence of polyps and variable colon dimensions on these parameters.
- To monitor the functionality of the activation mechanism and of the scanning circuitry (transmitter detectors).
- To collect data about the overall imaging of the colon internal surface during the passage of the capsule
- To develop a correlation map between the imaging of the polyps by optical colonoscopy vs. the images of same polyps by the Check-Cap capsule vs. the imaging of same polyps by CT Colonography (in patients which were referred after positive CTC examination)
- To estimate the total radiation exposure to each patient.
- To measure the distribution of the contrast material within the colon.
Design:
Prospective, Single arm, Multi-Center
Patient population:
Group A - First in Man:
Male and female subjects older than 40 and younger than 75 years old that are eligible for CRC screening and meet the eligibility criteria for study enrollment.
The study population will be enriched with up to 45 patients with known polyps detected by CTC or colonoscopy, in addition to 15 patient of the device's normal cohort.
All patients that are eligible for enrollment in the study will be tested by FOBT (Fecal Occult Blood Test) After the Capsule test, they will be referred for optical colonoscopy as part of the study
Group B - CE Pilot:
Male and female subjects older than 45 and younger than 75 years old that are eligible for CRC screening and meet the eligibility criteria for study enrollment.
All patients that are eligible for enrollment in the study will be tested by FIT ,. After the Capsule test they will be referred for optical colonoscopy Consenting patients with negative FIT testing scheduled for clinically-indicated optical colonoscopy without contraindication to either Check-Cap System imaging or optical colonoscopy, and able to undergo the bowel preparation necessary for optical colonoscopy.
Sample Size:
Total of 100 patients in both groups: A:3-5 + B: 55-57 subjects.
Study Procedure:
- st visit - recruitment and screening meeting with the Principal Investigator [PI]. Subject will receive the FIT test kit with detailed instructions for executing the test.
- nd visit - The FIT kits will be analyzed in order to diagnose the presence of blood in the stool. If the bowel log form is complete and the bowel frequency is not less than once per 2 days the subject will be asked to sign the Informed Consent Form [ICF] for ingesting the capsule.
- rd visit - Subject will ingest the capsule and continue ingestion of contrast material.
- th visit - Subjects will return to the PI with the excreted capsule which is expected within 24-100 hours after ingestion.
- th visit - All patients will undergo standard bowel preparation and optical colonoscopy between 10 and 30 days following imaging with the Check-Cap System.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| P1 capsule and screening Cscopy | Other | Device: The P1 Check-Cap capsuleMale and female patients older than 40 and younger than 75 years old who volunteer for the experiment and qualify with the inclusion / Exclusion criteria. The P1 Check-Cap capsule will be ingested by all participants. After the Capsule test, they will be referred for optical colonoscopy as part of the study |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female between 40 and 75 years of age.
- Subject is generally in good health.
- Subject is ready to undergo FOBT or FIT and Colonoscopy.
- Subject agrees to sign the informed consent.
Key exclusion criteria (9 listed)
- Subject has any known Gastro Intestinal [GI] related symptoms, complaints or GI diseases.
- Subject is contraindicated from performing colon cleansing (bowel prep.)
- Subject has cancer or other life threatening diseases or conditions.
- Female subject is pregnant.
- Subject underwent any abdominal surgery.
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 |
|---|---|---|
| The P1 Check-Cap capsuleThe P1 Check-Cap capsule will be ingested by all participants. After the Capsule test, they will be referred for optical colonoscopy as part of the study | Device | P1 capsule and screening Cscopy |
Primary outcome
safety - transit time (less than 300 hours)
Time frame: after each subject (once the capsule in excreted, typically 30-80 hours)
To evaluate the safety of the device in terms of total and segmental transit time and to study the effect of the presence of polyps and variable colon dimensions on these parameters. The measured effect is the correlation of the capsule transit time (hours) with the number of polyps and their size (in mm).
1 secondary outcome
Colon Capsule correlation map (Empirical, qualitative)
Time frame: end of study (anticipted within 12 months)
Results and safety
The study was stopped early (reason given: All trials ojectives were met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- sponsor's web pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Yoav Kimchy, Ph.D., study chair
yoav.kimchy@check-cap.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The P1 Check-Cap capsule in people with ColoRectal Cancer and Colonic Polyps, run by Check-Cap Ltd. at 1 site 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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 4 Feb 2019. 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 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 was stopped early (reason given: All trials ojectives were met). Results are not available in the source record.
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?
safety - transit time (less than 300 hours) (time frame: after each subject (once the capsule in excreted, typically 30-80 hours)). 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 4 Feb 2019.