NCT01458925

Brief Summary

Prospective, Single arm, Multi-Center

  1. 1.To establish the safety and preliminary efficacy of the Check-Cap System in patients with negative FOBT (Fecal Occult Blood Test)
  2. 2.To collect data about the overall imaging of the colon internal surface during the passage of the capsule
  3. 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)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
26 days until next milestone

Study Start

First participant enrolled

November 20, 2011

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2019

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

6.8 years

First QC Date

October 21, 2011

Last Update Submit

January 31, 2019

Conditions

ColoRectal CancerColonic Polyps

Keywords

Colorectal cancerColonic polyps

Outcome Measures

Primary Outcomes (1)

  • 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).

    after each subject (once the capsule in excreted, typically 30-80 hours)

Secondary Outcomes (1)

  • Colon Capsule correlation map (Empirical, qualitative)

    end of study (anticipted within 12 months)

Study Arms (1)

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

Device: The P1 Check-Cap capsule

Interventions

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

P1 capsule and screening Cscopy

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sorasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Polyps

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesIntestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Yoav Kimchy, Ph.D.,

    yoav.kimchy@check-cap.com

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2011

First Posted

October 25, 2011

Study Start

November 20, 2011

Primary Completion

September 16, 2018

Study Completion

January 2, 2019

Last Updated

February 4, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)