Feasibility of Check-Cap's P1 Capsule System Screening

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Ceck Cap Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Ceck Cap Ltd.
ClinicalTrials.gov Identifier:
NCT01458925
First received: October 21, 2011
Last updated: October 24, 2011
Last verified: October 2011
  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 Pre-malignant 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 30-50 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 4-6 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: 60
Study Start Date: November 2011
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Suject eligible for CRC screening by Colonoscopy
  • Male and female patients older than 50 and younger than 75 years old who volunteer for the experiment and qualify with the inclusion / Exclusion criteria
  • All patients that are eligible for enrollment in the study will be tested by FOBT, by the P1 capsule and then by Colonoscopy
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)

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 50 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 50 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 FOBT (Fecal Occult Blood Test) Those tested NEGATIVE will be offered to ingest the capsule. After the Capsule test they will be referred for optical colonoscopy Consenting patients with negative FOBT 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 60 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 FOBT test kit with detailed instructions for executing the test.
  2. nd visit - The FOBT kits will be analyzed in order to diagnose the presence of blood in the stool.

    In patients with NEGATIVE result the PI will examine the bowel log form. If it 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:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female between 50 and 75 years of age.
  • Subject is generally in good health.
  • Subject is ready to undergo FOBT 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

Contacts
Contact: Shlomo Lewkowicz, D.Sc. +972-52-4747234 shlomolw@netvision.net.il

Locations
Israel
Tel Aviv Sorasky Medical Center Not yet recruiting
Tel Aviv, Israel
Contact: Nadir Arber, Prof'    +972-3-6974896      
Principal Investigator: Menachem Moshkowicz, MD         
Sponsors and Collaborators
Ceck Cap Ltd.
  More Information

Additional Information:
No publications provided

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: October 24, 2011
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Precancerous Conditions
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 21, 2014