COLO-SW-1 Pivotal Clinical Investigation

Study Overview
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Brief Summary
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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.

Official Title
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COLO-SW-1 Clinical Investigation

Conditions
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Colonoscopy, Adenoma Colon

Intervention / Treatment
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* Device: COLO-SW-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old Consenting to participate Exclusion Criteria: Severe comorbidity, NYHA III-IV Pregnancy Hospitalized patients Active inflammatory bowel disease Poor bowel preparation defined as Boston Bowel Preparation Score as ≤1 in any segment Absence or unable to provide consent Cecum not reached

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inclusion group<br>Patients referred for colonoscopy: ≥18 years old Consenting to participate Exclusion criteria: Endoscopists Employment or family member employed at Augere Medical AS Patients: Severe comorbidity, NYHA III-IV Pregnancy Hospitalized patients Active inflammatory bowel disease Poor bowel preparation defined as Boston Bowel Preparation Score as ≤1 in any segment Absence or unable to provide consent Cecum not reached | Device: COLO-SW-1<br>* Patient will undergo a CADe-assisted colonoscopy procedure with use of the COLO-SW-1 software.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events (AE) |  | 2 months | 
| Number of technical problems disturbing the colonoscopy | Artifacts in the images on the endoscopy monitor Degradation of the endoscopic image quality due to the device | 2 months | 
| Confirming compatibility to the endoscopic system | The outcome is assessed by user questionnaire | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User manual understandability | The outcome is assessed by user questionnaire | 2 months | 
| Ease of activation of the device | The outcome is assessed by user questionnaire | 2 months | 
| Quality of visual alert | The outcome is assessed by user questionnaire | 2 months | 
| If the visual overlay disturbed polyp characterization | The outcome is assessed by user questionnaire | 2 months | 
| Number of procedures used with an AI system, the one under the investigation | The outcome is assessed by user questionnaire | 2 months |