Status:
COMPLETED
Motility of the Check-cap's MD1 Colon Capsule in Subjects Following Colon Rectal Cancer Screening by Colonoscopy
Lead Sponsor:
Check-Cap Ltd.
Conditions:
Colo-rectal Cancer
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
To monitor the Whole Gut Transit Time and repeatability of the motility of MD1 capsules in the colon of subjects with known polyps and in healthy subjects. Multi-Center, Open, Home Monitoring, Prospec...
Detailed Description
The subject population in this study will be composed of male and female subjects older than 40 and younger than 80 years old who volunteer for the experiment and qualify with the inclusion / exclusio...
Eligibility Criteria
Inclusion
- Male or female between 40 and 80 years of age
- Subjects which are generally healthy
- Subjects who were examined by colonoscopy during the previous 5 years period and can provide a copy of the report
- Subjects who are ready to undergo the monitoring routine and commit to at least two experiments
- Signed informed consent.
Exclusion
- Subjects with advanced cancer or other life threatening diseases or conditions
- Subject with known history of dysphagia or other swallowing disorders
- Subject with known history of Gastrointestinal disease or symptoms, such as: Crohn's disease, Colitis, Inflammatory bowel disease (IBD), Meckel's Diverticulum, Bowen Hernia, Mega Colon, fistulas or other strictures (doctors' discretion).
- Subject with known motility disorder or Chronic Constipation (less than 3 bowel movements/week)
- Subject with known delayed gastric emptying
- Subject with prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by physician discretion
- Subject with any condition believed to have an increased risk for capsule retention such as intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or Nonsteroidal anti-inflammatory drugs (NSAID) enteropathy, as determined by physician discretion
- Subjects with known sensitivity to iodine, or with kidney failure
- Subjects with morbid obesity (Body Mass Index \> 35)
- Subjects with belly / girth circumference \> 125 cm
- Subject with any known condition which precludes compliance with study and/or device instructions
- Subject with known condition of drug abuse and/or alcoholism
- Women who are either pregnant or nursing at the time of screening (to be verified by test in case of woman of child-bearing potential that do not practice medically acceptable methods of contraception)
- Concurrent participation in another clinical trial using any investigational drug or device
Key Trial Info
Start Date :
June 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2022
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03785665
Start Date
June 15 2019
End Date
January 11 2022
Last Update
January 19 2022
Active Locations (1)
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1
Bnai Zion Medical Center
Haifa, North, Israel, 33391