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Feasibility of Check-Cap's P1 Capsule System Screening

NCT01458925 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2019-02-04

No results posted yet for this study

Summary

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)

Conditions

Interventions

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

Sponsors & Collaborators

  • Check-Cap Ltd.

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-20
Primary Completion
2018-09-16
Completion
2019-01-02

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01458925 on ClinicalTrials.gov