Ignite Creation Date:
2024-05-06 @ 6:02 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05519098
Status:
COMPLETED
Last Update Posted:
2022-12-16
First Post:
2022-08-23
Brief Title:
COLO-SW-1 Pivotal Clinical Investigation
Sponsor:
Augere Medical AS
Organization:
Augere Medical AS
Study Overview
Official Title:
COLO-SW-1 Clinical Investigation
Status:
COMPLETED
Status Verified Date:
2022-12
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 Clinical Investigation is a summative usability study and a first-in-patient-study of the independent medical device software MDSW utilizing artificial intelligence The MDSW has completed the development phase and is ready to enter production The primary objective of this study is to assess the user safety and secondary the user-friendliness of the MDSW to confirm compliance to certain General safety and performance requirements GSPR set by the MDR The software to assess will be installed in a medical grade PC to allow the use of the MDSW according to its intended purpose of detecting colorectal polyps However the PC is not a part of the medical device under investigation and its performance and safety will not be assessed by this investigation The intended purpose and clinical benefit of the MDSW is to assist the endoscopist in detecting more polyps with the possibility of subsequently preventing colorectal cancer later on The data obtained from the investigation will be used for regulatory purposes aiming to obtain a CE certification as class IIa according to MDR for the MDSW under investigation
The multi-center investigation will assess 8-20 endoscopists experience with the MDSW and whether technical difficulties occur during its use in one site The user experience of the endoscopists will be collected in a questionnaire form The investigator will additionally record any possible adverse effects AE or adverse technical effects ATE of the use of the MDSW The MDSW will be used during ordinary colonoscopy in adult out-patients 18 years but variables related to the patient outcome will not be assessed Patients with inadequate bowel preparation active inflammation cecum not reached or not consenting will be excluded from the study Each endoscopist will assess the device during 3-5 patient examinations
The primary objective of the investigation is to confirm that COLO-SW-1 is safe for use during colonoscopy as intended for aiding in detection of polyps The secondary objective is to assess the user-friendliness of the MDSW interface
The clinical investigation is estimated to start in August 2022 The participation of the endoscopists will take place continuously through the clinical investigation until required number up to 20 of participants has been reached When 8 participants have been included in total an interim analysis is made and the Principal Investigator decides if the confirmatory objectives have been met A conclusion can be drawn from the partial objectives met at this point The study can continue for up to 20 participants to complete all endpoints if required The investigation will be closed by end of October 2022 The investigation will be deemed completed once the last evaluation form has been completed by the endoscopists
The multi-center investigation will assess 8-20 endoscopists experience with the MDSW and whether technical difficulties occur during its use in one site The user experience of the endoscopists will be collected in a questionnaire form The investigator will additionally record any possible adverse effects AE or adverse technical effects ATE of the use of the MDSW The MDSW will be used during ordinary colonoscopy in adult out-patients 18 years but variables related to the patient outcome will not be assessed Patients with inadequate bowel preparation active inflammation cecum not reached or not consenting will be excluded from the study Each endoscopist will assess the device during 3-5 patient examinations
The primary objective of the investigation is to confirm that COLO-SW-1 is safe for use during colonoscopy as intended for aiding in detection of polyps The secondary objective is to assess the user-friendliness of the MDSW interface
The clinical investigation is estimated to start in August 2022 The participation of the endoscopists will take place continuously through the clinical investigation until required number up to 20 of participants has been reached When 8 participants have been included in total an interim analysis is made and the Principal Investigator decides if the confirmatory objectives have been met A conclusion can be drawn from the partial objectives met at this point The study can continue for up to 20 participants to complete all endpoints if required The investigation will be closed by end of October 2022 The investigation will be deemed completed once the last evaluation form has been completed by the endoscopists
Detailed Description:
None
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