Ignite Creation Date:
2024-05-06 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03356002
Status:
COMPLETED
Last Update Posted:
2020-02-07
First Post:
2017-11-20
Brief Title:
Evaluation of C-Scan System in Providing Structural Information and Detection of Polypoid Lesions in High Risk Subjects
Sponsor:
Check-Cap Ltd
Organization:
Check-Cap Ltd
Study Overview
Official Title:
Evaluation of C-Scan System in Providing Structural Information and Detection of Polypoid Lesions in High Risk Subjects
Status:
COMPLETED
Status Verified Date:
2020-02
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:
The purpose of this study is to establish the efficacy of Check-Caps C-Scan System in providing structural information on colonic polypoid lesions and masses as an adjacent tool to Feacal Immunochemical Test FIT in high risk subjects
Detailed Description:
The subject will be invited to come to the clinic to sign the Informed Consent Form ICF and other related
The subjects will be connected to the C-Scan Track and following systems activation the subject will be asked to ingest the C-Scan Capsule with some water and contrast media in the presence of a physician
Post ingestion the subject will be discharged home with clear instructions on the procedure The subject should avoid intensive physical exercise during procedure or any extreme activities The subject should make an effort to stay at home or other familiar surroundings and may continue daily activities such mobilecomputerTelevision use shower sleep or eat Details on allowed and restricted activities are listed in app 4 The subject will be required to ingest daily dose 3 X 15-17ml of contrast media to be consumed three times per day with normal diet Also on a need based the subject would be provided with laxadine 5 mg tablets to be ingested according to the doctor recommendation
During capsule procedure the subjects will be contacted by phone several times daily by the site clinical study team or by dedicated external trained medical personnel to assure the subjects well-being and to monitor for any change or discomfort and for procedure progress Subjects may be also monitored by the technical team either at home or at the clinic who may need to examine the system or inquire the subjects about the system visualauditory indicators
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
Capsule procedure is completed upon capsule excretion or system vibroauditory indication of End of Procedure
Once the procedure is completed The C-Scan Capsule and C-Scan Track will be collected from the subject and returned to the sponsors lab for preliminary analysis
All subjects will be scheduled for optical colonoscopy to be performed within one month following capsule procedure
C-Scan Procedure Analysis
Several 3-6 licensed gastroenterologist physicians will be trained with reviewing and analyzing C-Scan System scans to serve as independent reviewers Each case will be reviewed by 3 independant reviewers The reviewing forum will be blinded to the FIT and colonoscopy results of the examined patients Analysis will be performed on a per patient basis for the existence or non-existence of a finding that may be a polyp This per patient finding will be compared with the FIT and a colonoscopy will be performed for verification
The subjects will be connected to the C-Scan Track and following systems activation the subject will be asked to ingest the C-Scan Capsule with some water and contrast media in the presence of a physician
Post ingestion the subject will be discharged home with clear instructions on the procedure The subject should avoid intensive physical exercise during procedure or any extreme activities The subject should make an effort to stay at home or other familiar surroundings and may continue daily activities such mobilecomputerTelevision use shower sleep or eat Details on allowed and restricted activities are listed in app 4 The subject will be required to ingest daily dose 3 X 15-17ml of contrast media to be consumed three times per day with normal diet Also on a need based the subject would be provided with laxadine 5 mg tablets to be ingested according to the doctor recommendation
During capsule procedure the subjects will be contacted by phone several times daily by the site clinical study team or by dedicated external trained medical personnel to assure the subjects well-being and to monitor for any change or discomfort and for procedure progress Subjects may be also monitored by the technical team either at home or at the clinic who may need to examine the system or inquire the subjects about the system visualauditory indicators
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
Capsule procedure is completed upon capsule excretion or system vibroauditory indication of End of Procedure
Once the procedure is completed The C-Scan Capsule and C-Scan Track will be collected from the subject and returned to the sponsors lab for preliminary analysis
All subjects will be scheduled for optical colonoscopy to be performed within one month following capsule procedure
C-Scan Procedure Analysis
Several 3-6 licensed gastroenterologist physicians will be trained with reviewing and analyzing C-Scan System scans to serve as independent reviewers Each case will be reviewed by 3 independant reviewers The reviewing forum will be blinded to the FIT and colonoscopy results of the examined patients Analysis will be performed on a per patient basis for the existence or non-existence of a finding that may be a polyp This per patient finding will be compared with the FIT and a colonoscopy will be performed for verification
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