Status:
TERMINATED
Feasibility of Check-Cap's P1 Capsule System Screening
Lead Sponsor:
Check-Cap Ltd.
Conditions:
ColoRectal Cancer
Colonic Polyps
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief 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...
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 neg...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2019
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT01458925
Start Date
November 20 2011
End Date
January 2 2019
Last Update
February 4 2019
Active Locations (1)
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1
Tel Aviv Sorasky Medical Center
Tel Aviv, Israel