NCT03785665

Motility of the Check-cap's MD1 Colon Capsule in Subjects Following Colon Rectal Cancer Screening by Colonoscopy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Check-Cap Ltd. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

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, Prospective Study. Up to 100 participants in various phases 2-5 capsules per person, (1 capsule at a time) The primary objective of the study is to monitor the variability of the motility of the MD1 capsules in the Gastrointestinal tract of human subjects with and without polyps in previous Colonoscopy.

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 / exclusion criteria A total of one hundred (100) subjects will be enrolled in this study. All study participants will be examined by the MD1 capsules, 2-5 capsules per person, one capsule at a time. Efforts will be made to maintain balanced numbers between men and women and even distribution of ages. The study will be conducted by phases: A 15-20 Men with polyps in previous Colonoscopy (2-3 repeated ingestions) B. 10-20 Men With no polyps in previous Colonoscopy (1-2 repeated ingestions) C. 15-20 Women with polyps in previous Colonoscopy (2-3 repeated ingestions) D. 10-20 Women With no polyps in previous Colonoscopy (1-2 repeated ingestions) E Same as A-D with the use of prokinetic drugs F. Same as A-D with different type of capsules (lower weight and/or rounded caps on both sides). The total duration of the study for each subject is two-four weeks. Each subject will ingest 2-5 capsules, one at a time, with at least 1 week apart between repeated ingestion 1. st Visit (phone interview) - Each subject will receive a comprehensive explanation regarding the study nature. During this process, and per ethical committee approval, subjects may be asked several questions (over the phone) regarding their medical background for preliminary assessment of eligibility. 2. nd Visit - Once informed consent is obtained, a thorough evaluation of subject's eligibility will be performed based on inclusion / exclusion criteria. Consent to participate in this study must be given in writing. The signed informed consent will remain in subject's file. A signed copy will be given to the subject. Subject will ingest the capsule (in the presence of a medical professional). Post ingestion, the subject will receive detailed instructions about the daily routine and activities and then will be discharged home with written instructions on the procedure (IFU - Instructions for use). The subject should avoid intensive physical exercise during the procedure or any extreme activities. The subject should make an effort to stay at home or other familiar surroundings (within 2 hours of driving from the clinic), and may continue daily activities such mobile/computer/TV (Television) use, shower, sleep or eat. Details on allowed and restricted activities are listed in the Information For use which is included in the Kit). All subjects will be provided with a contact card with study details and site contact information (24/7). Discharged home

Conditions

• Colo-rectal Cancer

Interventions

Type	Name	Description
DEVICE	MDI	Capsule MD1 (Motility dummy 1)

Timeline

• Start date: 2019-06-15
• Primary completion: 2022-01-01
• Completion: 2022-01-11
• First posted: 2018-12-24
• Last updated: 2022-01-19

Locations

1 site across 1 country: Israel