Ignite Creation Date:
2024-05-06 @ 1:29 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04038736
Status:
COMPLETED
Last Update Posted:
2022-02-17
First Post:
2019-06-27
Brief Title:
Evaluation C-Scan System in Providing Structural Information and Polypoid Lesions in the Colon of Healthy Subjects
Sponsor:
Check-Cap Ltd
Organization:
Check-Cap Ltd
Study Overview
Official Title:
Evaluation of Check-Cap C-Scan System in Providing Structural Information and Detection of Polypoid Lesions in Subjects at Average or High Risk for CRC
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:
CRC
Brief Summary:
Up to 300 subjects will participate in this study Subjects to be enrolled in this study are typically healthy and at average or high risk for CRC
Each subject will undergo study assessments including a pre-screening telephone call Procedure Visit follow up post-ingestion via telephone calls
On the day of the procedure before administering the C-Scan Once informed consent is obtained a thorough evaluation of subjects eligibility will be performed based on inclusion exclusion criteria Medical history and concomitant medications information will be collected for all subjects Also prior surgeries or endoscopic examinations showing pathology and current or previous GI problems or symptoms will be evaluated
Some subjects will be asked to participate in additional ingestions up to three one at a time at least one week intermission between the ingestions to compare the performance of the system in different configuration on the same subject
Each subjects participation in the study will take up to 3 weeks per one ingestion
Some subjects will be asked to participate in addition ingestions up to three one at a time at least one week intermission between the ingestions to compare the performance of the system in different configuration on the same subject
Overall study duration will be one year
Each subject will undergo study assessments including a pre-screening telephone call Procedure Visit follow up post-ingestion via telephone calls
On the day of the procedure before administering the C-Scan Once informed consent is obtained a thorough evaluation of subjects eligibility will be performed based on inclusion exclusion criteria Medical history and concomitant medications information will be collected for all subjects Also prior surgeries or endoscopic examinations showing pathology and current or previous GI problems or symptoms will be evaluated
Some subjects will be asked to participate in additional ingestions up to three one at a time at least one week intermission between the ingestions to compare the performance of the system in different configuration on the same subject
Each subjects participation in the study will take up to 3 weeks per one ingestion
Some subjects will be asked to participate in addition ingestions up to three one at a time at least one week intermission between the ingestions to compare the performance of the system in different configuration on the same subject
Overall study duration will be one year
Detailed Description:
Study Population
A total of 300 healthy subjects Male or female at average or high risk for CRC will be enrolled for the study
Visit 1 C-Scan Procedure Visit This visit is performed in order to ensure that the subject continues to meet all inclusion and has no exclusion criteria and has had adequate time to review the consent form and to ask questions Once it has been determined that the subject meets all inclusion and has no exclusion criteria and the subject chooses to participate in the study the consent form will be signed and dated by all appropriate parties prior to execution of study-specific assessments Signing the informed consent form signifies enrollment in the clinical study
Capsule ingestion will take place at this visit Additionally the subject will receive detailed training session and instructions including explanation from the site study team about the device its usage and the required documentation described below Following subject training the Capsule will be ingested C-Scan Initiation Procedure at this visit as described below
C-Scan Initiation Procedure
Subject will be connected to the C-Scan Track and system will be activated The subject will be asked to ingest the C-Scan Capsule in the presence of a physician with some water and water-soluble iodinated oral contrast medium indicated for radiographic examination of segments of the gastrointestinal tract and non-soluble fiber supplements
Post ingestion the subject will be discharged home with a Subject Instructions Packet which will include instructions on following routine daily regime ie ingestion of contrast media 3 x 15ml per day and non-soluble fiber supplements X3 per day until capsule excretion and record in a personal formatted diary the timing of specific activities such as bowel movements daily activities and discomfort assessment via a validated scale Also included will be Subject Satisfaction surveys that the subject should complete at the end of the procedure and return to the site upon completion
Capsule Progress Days
During the days in which the capsule is progressing within the subject the subject is required to ingest contrast media GE Omnipaque 350 FDA approved under NDA 018956 as well as non-soluble fiber supplements The subject will be required to ingest daily dose 3 X 15 ml of contrast media to be consumed three times per day as well a non-soluble fiber 3xday with normal diet
Subjects will be required to undergo FIT procedure along with the C-Scan System procedure per package insert instructions The subject will be provided with Laxadin 5 mg tablets to be ingested according to the doctor recommendation on an as needed basis In routine procedures subjects might be instructed to take 2 X 5 mg tablets 48-72 hours after ingestions unless the capsule was already excreted
Some subjects will be asked by the PI to come to the site for an abdominal X-Ray fluoroscopy while the capsule is still in the colon
All subjects will be required to keep a log Subjects Diary during procedure documenting general activities contrast media intake fibers intake and food consumption bowel movement and system visualauditory indicators
Phone Call Follow-Up During-C-Scan Procedure
After Capsule ingestion the subject will be contacted by phone at least twice daily by the study team until the capsule has been excreted The subject will be asked to provide feedback about the use of the device excretion of the capsule hisher general feeling or any inconvenience and will be reminded to complete the daily diary and discomfort assessment The conversation with the subjects and their responses are tabulated and recorded in the study file
C-Scan Procedure End
Capsule procedure is completed upon capsule excretion or system auditory indication of End of Procedure Subjects will be asked to call the study team upon capsule excretion
The subjects will be provided with a dedicated capsule collection kit to assist the subjects in collecting the capsule Subjects will be instructed to retrieve the capsule upon excretion Return packaging and instructions will be provided The subject will return with the Kit the diary the questionnaire and all unused materials
Follow-Up Phone Call Post-C-Scan Procedure End
Follow up window is 1-3 days post-capsule excretion Subject will be telephoned by study site to assess for any undesired events
In case of doubt regarding capsule excretion and per physician discretion subjects may be referred to abdominal X-Ray to confirm capsule excretion
Colonoscopy examination optional
A total of 300 healthy subjects Male or female at average or high risk for CRC will be enrolled for the study
Visit 1 C-Scan Procedure Visit This visit is performed in order to ensure that the subject continues to meet all inclusion and has no exclusion criteria and has had adequate time to review the consent form and to ask questions Once it has been determined that the subject meets all inclusion and has no exclusion criteria and the subject chooses to participate in the study the consent form will be signed and dated by all appropriate parties prior to execution of study-specific assessments Signing the informed consent form signifies enrollment in the clinical study
Capsule ingestion will take place at this visit Additionally the subject will receive detailed training session and instructions including explanation from the site study team about the device its usage and the required documentation described below Following subject training the Capsule will be ingested C-Scan Initiation Procedure at this visit as described below
C-Scan Initiation Procedure
Subject will be connected to the C-Scan Track and system will be activated The subject will be asked to ingest the C-Scan Capsule in the presence of a physician with some water and water-soluble iodinated oral contrast medium indicated for radiographic examination of segments of the gastrointestinal tract and non-soluble fiber supplements
Post ingestion the subject will be discharged home with a Subject Instructions Packet which will include instructions on following routine daily regime ie ingestion of contrast media 3 x 15ml per day and non-soluble fiber supplements X3 per day until capsule excretion and record in a personal formatted diary the timing of specific activities such as bowel movements daily activities and discomfort assessment via a validated scale Also included will be Subject Satisfaction surveys that the subject should complete at the end of the procedure and return to the site upon completion
Capsule Progress Days
During the days in which the capsule is progressing within the subject the subject is required to ingest contrast media GE Omnipaque 350 FDA approved under NDA 018956 as well as non-soluble fiber supplements The subject will be required to ingest daily dose 3 X 15 ml of contrast media to be consumed three times per day as well a non-soluble fiber 3xday with normal diet
Subjects will be required to undergo FIT procedure along with the C-Scan System procedure per package insert instructions The subject will be provided with Laxadin 5 mg tablets to be ingested according to the doctor recommendation on an as needed basis In routine procedures subjects might be instructed to take 2 X 5 mg tablets 48-72 hours after ingestions unless the capsule was already excreted
Some subjects will be asked by the PI to come to the site for an abdominal X-Ray fluoroscopy while the capsule is still in the colon
All subjects will be required to keep a log Subjects Diary during procedure documenting general activities contrast media intake fibers intake and food consumption bowel movement and system visualauditory indicators
Phone Call Follow-Up During-C-Scan Procedure
After Capsule ingestion the subject will be contacted by phone at least twice daily by the study team until the capsule has been excreted The subject will be asked to provide feedback about the use of the device excretion of the capsule hisher general feeling or any inconvenience and will be reminded to complete the daily diary and discomfort assessment The conversation with the subjects and their responses are tabulated and recorded in the study file
C-Scan Procedure End
Capsule procedure is completed upon capsule excretion or system auditory indication of End of Procedure Subjects will be asked to call the study team upon capsule excretion
The subjects will be provided with a dedicated capsule collection kit to assist the subjects in collecting the capsule Subjects will be instructed to retrieve the capsule upon excretion Return packaging and instructions will be provided The subject will return with the Kit the diary the questionnaire and all unused materials
Follow-Up Phone Call Post-C-Scan Procedure End
Follow up window is 1-3 days post-capsule excretion Subject will be telephoned by study site to assess for any undesired events
In case of doubt regarding capsule excretion and per physician discretion subjects may be referred to abdominal X-Ray to confirm capsule excretion
Colonoscopy examination optional
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