An interventional study of MDI in Colo-rectal Cancer, sponsored by Check-Cap Ltd.. Completed at 1 site in Israel. Open to participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-19.
Sponsored by Check-Cap Ltd. · Not applicable, Interventional, and Diagnostic
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.
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
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
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 88 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Check-Cap Ltd. is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
Device: MDI
Capsule MD1 (Motility dummy 1)
Also known as: Capsule MD1 (Motility dummy 1)
Measure the variability of the motility (Whole gut transit time from ingestion to excretion {hours}) of the MD1 (Motility dummy 1) capsules in the Gastrointestinal tract of human subjects with and w/out polyps in previous Colonoscopy.
All participating subjects will be consented for multiple measurements. In selected subjects the experiment will be repeated with same type MD1 capsule but w/out the drug, to compare the effect of the drug on the motility and the instantaneous speed during contractions. These subjects will be selected according to their results in the first round, ease of adjustment to the monitoring routine, retrieval of the excreted capsules and lack of any side effects or complains. The repeated procedure will be at least 1 week apart and will be approved by the investigator only after positive identification of the excretion of the first capsule. Naturally, there is no need to repeat the colonoscopy procedure The repeated tests will be conducted according to the same protocol. There are no additional safety issues in the re-ingestions tests since the 1st capsule has to be excreted and retrieved few days before the repeated experiment starts
Time frame: 12 months
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Check-Cap Ltd.