Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
34 participants
OBSERVATIONAL
2022-08-23
2022-10-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
COLO-SW-1
Patient will undergo a CADe-assisted colonoscopy procedure with use of the COLO-SW-1 software.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
COLO-SW-1
Patient will undergo a CADe-assisted colonoscopy procedure with use of the COLO-SW-1 software.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Consenting to participate
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Oslo University Hospital
OTHER
Sahlgrenska University Hospital
OTHER
Augere Medical AS
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oslo University Hospital
Oslo, , Norway
Sahlgrenska University Hospital-Mölndal
Gothenburg, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CIV-22-04-039386
Identifier Type: -
Identifier Source: org_study_id