Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Feasibility of Check-Cap's P1 Capsule System Screening

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ceck Cap Ltd.
ClinicalTrials.gov Identifier:
NCT01458925
First received: October 21, 2011
Last updated: May 4, 2016
Last verified: May 2016
  Purpose

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)

Condition Intervention
ColoRectal Cancer
Colonic Polyps
Device: The P1 Check-Cap capsule

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Feasibility, Multi-center Prospective Study of Check-Cap's P1 Capsule System in Patients Eligible for ColoRectal Cancer [CRC] Screening

Resource links provided by NLM:


Further study details as provided by Ceck Cap Ltd.:

Primary Outcome Measures:
  • safety - transit time (less than 300 hours) [ Time Frame: after each subject (once the capsule in excreted, typically 30-80 hours) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: end of study (anticipted within 12 months) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Hide Detailed Description

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.
  Eligibility

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458925

Locations
Israel
Tel Aviv Sorasky Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Ceck Cap Ltd.
Investigators
Study Chair: Yoav Kimchy, Ph.D., yoav.kimchy@check-cap.com
  More Information

Additional Information:
Responsible Party: Ceck Cap Ltd.
ClinicalTrials.gov Identifier: NCT01458925     History of Changes
Other Study ID Numbers: CL-SY-01-0091 
Study First Received: October 21, 2011
Last Updated: May 4, 2016
Health Authority: Israel: Ministry of Health
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Ceck Cap Ltd.:
Colorectal cancer
Colonic polyps

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Polyps
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 30, 2016