Feasibility of Check-Cap's P1 Capsule System Screening

January 31, 2019 updated by: Check-Cap Ltd.

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

  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. 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)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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:

  1. 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.

  2. 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.

  3. rd visit - Subject will ingest the capsule and continue ingestion of contrast material.
  4. th visit - Subjects will return to the PI with the excreted capsule which is expected within 24-100 hours after ingestion.
  5. 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 Type

Interventional

Enrollment (Actual)

143

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Tel Aviv Sorasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: P1 capsule and screening Cscopy

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
Device: The P1 Check-Cap capsule
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
after each subject (once the capsule in excreted, typically 30-80 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Colon Capsule correlation map (Empirical, qualitative)
Time Frame: end of study (anticipted within 12 months)
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.
end of study (anticipted within 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Check-Cap Ltd.

Investigators

  • Study Chair: Yoav Kimchy, Ph.D.,, yoav.kimchy@check-cap.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 20, 2011

Primary Completion (ACTUAL)

September 16, 2018

Study Completion (ACTUAL)

January 2, 2019

Study Registration Dates

First Submitted

October 21, 2011

First Submitted That Met QC Criteria

October 24, 2011

First Posted (ESTIMATE)

October 25, 2011

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-SY-01-0091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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