Ignite Creation Date:
2024-05-06 @ 12:21 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03735407
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2018-11-05
Brief Title:
SafetyUsability and Compliance of Using C-Scan System for Providing Information on Colonic Polypoid Lesions and Masses
Sponsor:
Check-Cap Ltd
Organization:
Check-Cap Ltd
Study Overview
Official Title:
Evaluation of Safety Usability and Subject Compliance While Using Check- Caps C-Scan System for Providing Structural Information on Colonic Polypoid Lesions and Masses
Status:
COMPLETED
Status Verified Date:
2023-08
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:
C-Scan
Brief Summary:
Protocol Title Evaluation of safety usability and subject compliance while using Check- Caps C-Scan System for providing structural information on colonic polypoid lesions and masses Study Design Prospective Multi-center Single-arm safety study Purpose To demonstrate the safety of the Check-Cap C-Scan System Study Centers Up to two 2 centers located in the United States Number of Participants 45 healthy subjects Investigational Device Check-Caps C-Scan System comprises C-Scan Capsule C-Scan Track and C-Scan View
Primary Objective To evaluate the safety of the Check-Cap C-Scan System Secondary Objectives a To evaluate subjects compliance b To evaluate subjects satisfaction c To collect data to improve the products algorithm
Primary Objective To evaluate the safety of the Check-Cap C-Scan System Secondary Objectives a To evaluate subjects compliance b To evaluate subjects satisfaction c To collect data to improve the products algorithm
Detailed Description:
Overall Design Up to 45 healthy subjects will participate in this study Subjects to be enrolled in this study are indicated and scheduled to undergo optical colonoscopy based on the following symptoms or by being classified as higher than average risk based on one or more of the following
Surveillance - Significant findings in previous optical colonoscopy
Diagnostic - Polyps detected in virtual colonoscopy referred for polypectomy
Diagnostic - Polyps detected in previous optical colonoscopy community setting referred for polypectomy
Diagnostic - Positive FIT Fecal Immunochemical Test
Diagnostic - one or more of the typical symptoms
abdominal pain
Change in bowel habits
Anemia or overt bleeding in stool
Significant weight loss
First degree relatives of CRC Colo-Rectal Cancersubjects Alternatively average risk based on their age and demographics referred for screening for polyps
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 Once informed consent is obtained a thorough evaluation of subjects eligibility will be performed based on inclusion exclusion criteria
Eligible subjects will be required to undergo FIT procedure per package insert instructions within pre-defined timelines All subjects will be scheduled to undergo capsule procedure to be followed later on with optical colonoscopy procedure
One to three days following end of C-Scan procedure the subjects will be contacted by phone by the clinical coordinator to follow-up on the subject well-being Same follow-up procedures will be applied one to three days following Optical Colonoscopy procedure Medical history and concomitant medication information will be collected for all subjects
Study Duration The duration of study participation for each subject is expected to be approximately 8-10 weeks The total study duration across all patients is expected to be approximately 6 months dependent upon subject recruitment rate
C-Scan Procedure Subjects will be instructed to skip breakfast or lunch on the day of C-Scan Capsule ingestion to expedite gastric passage Liquids are allowed
The subjects will be connected to the C-Scan Track and after successful systems activation BIT - built in test the subject will be asked to ingest the C-Scan Capsule with some water contrast media GE Omnipaque 350 and non-soluble fiber in the presence of a physician investigator or designee The subject will also be provided with an RF watch A representative of the sponsor will attend the ingestion procedure as needed to assure proper activation
Post ingestion the subject will receive detailed instructions about the daily routine and activities as well as use of the RF watch and then will be discharged home with written instructions on the procedure Instructions for use IFU daily diary FIT kit and capsule return kit
FIT Procedure All subjects will be required to perform FIT procedure using OC-Light FIT Kit prior or during the capsule procedure Capsule Return Capsule procedure is completed upon capsule excretion or system auditory indication of End of Procedure Subjects will be instructed to inform the study coordinator or designee upon capsule excretion
Surveillance - Significant findings in previous optical colonoscopy
Diagnostic - Polyps detected in virtual colonoscopy referred for polypectomy
Diagnostic - Polyps detected in previous optical colonoscopy community setting referred for polypectomy
Diagnostic - Positive FIT Fecal Immunochemical Test
Diagnostic - one or more of the typical symptoms
abdominal pain
Change in bowel habits
Anemia or overt bleeding in stool
Significant weight loss
First degree relatives of CRC Colo-Rectal Cancersubjects Alternatively average risk based on their age and demographics referred for screening for polyps
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 Once informed consent is obtained a thorough evaluation of subjects eligibility will be performed based on inclusion exclusion criteria
Eligible subjects will be required to undergo FIT procedure per package insert instructions within pre-defined timelines All subjects will be scheduled to undergo capsule procedure to be followed later on with optical colonoscopy procedure
One to three days following end of C-Scan procedure the subjects will be contacted by phone by the clinical coordinator to follow-up on the subject well-being Same follow-up procedures will be applied one to three days following Optical Colonoscopy procedure Medical history and concomitant medication information will be collected for all subjects
Study Duration The duration of study participation for each subject is expected to be approximately 8-10 weeks The total study duration across all patients is expected to be approximately 6 months dependent upon subject recruitment rate
C-Scan Procedure Subjects will be instructed to skip breakfast or lunch on the day of C-Scan Capsule ingestion to expedite gastric passage Liquids are allowed
The subjects will be connected to the C-Scan Track and after successful systems activation BIT - built in test the subject will be asked to ingest the C-Scan Capsule with some water contrast media GE Omnipaque 350 and non-soluble fiber in the presence of a physician investigator or designee The subject will also be provided with an RF watch A representative of the sponsor will attend the ingestion procedure as needed to assure proper activation
Post ingestion the subject will receive detailed instructions about the daily routine and activities as well as use of the RF watch and then will be discharged home with written instructions on the procedure Instructions for use IFU daily diary FIT kit and capsule return kit
FIT Procedure All subjects will be required to perform FIT procedure using OC-Light FIT Kit prior or during the capsule procedure Capsule Return Capsule procedure is completed upon capsule excretion or system auditory indication of End of Procedure Subjects will be instructed to inform the study coordinator or designee upon capsule excretion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None