Ignite Creation Date:
2024-05-06 @ 12:31 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03785665
Status:
COMPLETED
Last Update Posted:
2022-01-19
First Post:
2018-11-28
Brief Title:
Motility of the Check-caps MD1 Colon Capsule in Subjects Following Colon Rectal Cancer Screening by Colonoscopy
Sponsor:
Check-Cap Ltd
Organization:
Check-Cap Ltd
Study Overview
Official Title:
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
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 andor 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 subjects 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 subjects 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 mobilecomputerTV 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 247
Discharged home
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 andor 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 subjects 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 subjects 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 mobilecomputerTV 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 247
Discharged home
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None