Feasibility of Check-Cap's P1 Capsule System Screening
Primary Purpose
ColoRectal Cancer, Colonic Polyps
Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
The P1 Check-Cap capsule
Sponsored by

About this trial
This is an interventional diagnostic trial for ColoRectal Cancer focused on measuring Colorectal cancer, Colonic polyps
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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
Sites / Locations
- Tel Aviv Sorasky Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
P1 capsule and screening Cscopy
Arm Description
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
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01458925
Brief Title
Feasibility of Check-Cap's P1 Capsule System Screening
Official Title
Feasibility, Multi-center Prospective Study of Check-Cap's P1 Capsule System in Patients Eligible for ColoRectal Cancer [CRC] Screening
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
All trials ojectives were met
Study Start Date
November 20, 2011 (Actual)
Primary Completion Date
September 16, 2018 (Actual)
Study Completion Date
January 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Check-Cap Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ColoRectal Cancer, Colonic Polyps
Keywords
Colorectal cancer, Colonic polyps
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
P1 capsule and screening Cscopy
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
The P1 Check-Cap capsule
Intervention Description
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
Primary Outcome Measure Information:
Title
safety - transit time (less than 300 hours)
Description
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).
Time Frame
after each subject (once the capsule in excreted, typically 30-80 hours)
Secondary Outcome Measure Information:
Title
Colon Capsule correlation map (Empirical, qualitative)
Description
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.
Time Frame
end of study (anticipted within 12 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoav Kimchy, Ph.D.,
Organizational Affiliation
yoav.kimchy@check-cap.com
Official's Role
Study Chair
Facility Information:
Facility Name
Tel Aviv Sorasky Medical Center
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://check-cap.com
Description
sponsor's web page
Learn more about this trial
Feasibility of Check-Cap's P1 Capsule System Screening
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