Ignite Creation Date:
2024-05-05 @ 11:57 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01458925
Status:
TERMINATED
Last Update Posted:
2019-02-04
First Post:
2011-10-21
Brief Title:
Feasibility of Check-Caps P1 Capsule System Screening
Sponsor:
Check-Cap Ltd
Organization:
Check-Cap Ltd
Study Overview
Official Title:
Feasibility Multi-center Prospective Study of Check-Caps P1 Capsule System in Patients Eligible for ColoRectal Cancer CRC Screening
Status:
TERMINATED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
All trials ojectives were met
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 overall imaging of the colon internal surface during the passage of the capsule
3 To develop a correlation map between the imaging of the polyps by optical colonoscopy vs the images of same polyps by the Check-Cap capsule vs the imaging of same polyps by CT Colonography CTC in patients which were referred after positive CTC examination
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 overall imaging of the colon internal surface during the passage of the capsule
3 To develop a correlation map between the imaging of the polyps by optical colonoscopy vs the images of same polyps by the Check-Cap capsule vs the imaging of same polyps by CT Colonography CTC in patients which were referred after positive CTC examination
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 negative FOBT Fecal Occult Blood Test or FIT
Secondary
To evaluate the safety of the device in terms of total and segmental transit time and to study the effect of the presence of polyps and variable colon dimensions on these parameters
To monitor the functionality of the activation mechanism and of the scanning circuitry transmitter detectors
To collect data about the overall imaging of the colon internal surface during the passage of the capsule
To develop a correlation map between the imaging of the polyps by optical colonoscopy vs the images of same polyps by the Check-Cap capsule vs the imaging of same polyps by CT Colonography in patients which were referred after positive CTC examination
To estimate the total radiation exposure to each patient
To measure the distribution of the contrast material within the colon
Design
Prospective Single arm Multi-Center
Patient population
Group A - First in Man
Male and female subjects older than 40 and younger than 75 years old that are eligible for CRC screening and meet the eligibility criteria for study enrollment
The study population will be enriched with up to 45 patients with known polyps detected by CTC or colonoscopy in addition to 15 patient of the devices normal cohort
All patients that are eligible for enrollment in the study will be tested by FOBT Fecal Occult Blood Test After the Capsule test they will be referred for optical colonoscopy as part of the study
Group B - CE Pilot
Male and female subjects older than 45 and younger than 75 years old that are eligible for CRC screening and meet the eligibility criteria for study enrollment
All patients that are eligible for enrollment in the study will be tested by FIT After the Capsule test they will be referred for optical colonoscopy Consenting patients with negative FIT testing scheduled for clinically-indicated optical colonoscopy without contraindication to either Check-Cap System imaging or optical colonoscopy and able to undergo the bowel preparation necessary for optical colonoscopy
Sample Size
Total of 100 patients in both groups A3-5 B 55-57 subjects
Study Procedure
1 st visit - recruitment and screening meeting with the Principal Investigator PI Subject will receive the FIT test kit with detailed instructions for executing the test
2 nd visit - The FIT kits will be analyzed in order to diagnose the presence of blood in the stool
If the bowel log form is complete and the bowel frequency is not less than once per 2 days the subject will be asked to sign the Informed Consent Form ICF for ingesting the capsule
3 rd visit - Subject will ingest the capsule and continue ingestion of contrast material
4 th visit - Subjects will return to the PI with the excreted capsule which is expected within 24-100 hours after ingestion
5 th visit - All patients will undergo standard bowel preparation and optical colonoscopy between 10 and 30 days following imaging with the Check-Cap System
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 negative FOBT Fecal Occult Blood Test or FIT
Secondary
To evaluate the safety of the device in terms of total and segmental transit time and to study the effect of the presence of polyps and variable colon dimensions on these parameters
To monitor the functionality of the activation mechanism and of the scanning circuitry transmitter detectors
To collect data about the overall imaging of the colon internal surface during the passage of the capsule
To develop a correlation map between the imaging of the polyps by optical colonoscopy vs the images of same polyps by the Check-Cap capsule vs the imaging of same polyps by CT Colonography in patients which were referred after positive CTC examination
To estimate the total radiation exposure to each patient
To measure the distribution of the contrast material within the colon
Design
Prospective Single arm Multi-Center
Patient population
Group A - First in Man
Male and female subjects older than 40 and younger than 75 years old that are eligible for CRC screening and meet the eligibility criteria for study enrollment
The study population will be enriched with up to 45 patients with known polyps detected by CTC or colonoscopy in addition to 15 patient of the devices normal cohort
All patients that are eligible for enrollment in the study will be tested by FOBT Fecal Occult Blood Test After the Capsule test they will be referred for optical colonoscopy as part of the study
Group B - CE Pilot
Male and female subjects older than 45 and younger than 75 years old that are eligible for CRC screening and meet the eligibility criteria for study enrollment
All patients that are eligible for enrollment in the study will be tested by FIT After the Capsule test they will be referred for optical colonoscopy Consenting patients with negative FIT testing scheduled for clinically-indicated optical colonoscopy without contraindication to either Check-Cap System imaging or optical colonoscopy and able to undergo the bowel preparation necessary for optical colonoscopy
Sample Size
Total of 100 patients in both groups A3-5 B 55-57 subjects
Study Procedure
1 st visit - recruitment and screening meeting with the Principal Investigator PI Subject will receive the FIT test kit with detailed instructions for executing the test
2 nd visit - The FIT kits will be analyzed in order to diagnose the presence of blood in the stool
If the bowel log form is complete and the bowel frequency is not less than once per 2 days the subject will be asked to sign the Informed Consent Form ICF for ingesting the capsule
3 rd visit - Subject will ingest the capsule and continue ingestion of contrast material
4 th visit - Subjects will return to the PI with the excreted capsule which is expected within 24-100 hours after ingestion
5 th visit - All patients will undergo standard bowel preparation and optical colonoscopy between 10 and 30 days following imaging with the Check-Cap System
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None