COLO-SW-1 Pivotal Clinical Investigation

COLO-SW-1 Clinical Investigation

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy; Adenoma Colon
• Intervention / Treatment: Device: COLO-SW-1

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0450
    • Oslo University Hospital
• Sweden
  • Göteborg, Sweden, 41345
    • Sahlgrenska University Hospital-Mölndal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

General population with a referral to colonoscopy.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Inclusion group; 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; Patient will undergo a CADe-assisted colonoscopy procedure with use of the COLO-SW-1 software.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Augere Medical AS
• Collaborators: Oslo University Hospital; Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2022
• Primary Completion (Actual): October 26, 2022
• Study Completion (Actual): October 26, 2022

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: CIV-22-04-039386

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No