ColonoscopyNCT05519098
COLO-SW-1 Pivotal Clinical Investigation
An observational study of Colonoscopy and Adenoma Colon, run by Augere Medical AS at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy, Adenoma Colon
- What is being tested?
- COLO-SW-1
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 34 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Aug 2022to 26 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General population with a referral to colonoscopy.
Who may be able to join
- ≥18 years old
- Consenting to participate
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
Read more
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.
- Conditions
- Colonoscopy, Adenoma Colon
- Being tested
- COLO-SW-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COLO-SW-1Device
Patient will undergo a CADe-assisted colonoscopy procedure with use of the COLO-SW-1 software.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: COLO-SW-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events (AE)
Measured: 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
Measured: 2 months
Confirming compatibility to the endoscopic system
The outcome is assessed by user questionnaire
Measured: 2 months
Secondary outcomes (5)
User manual understandability
The outcome is assessed by user questionnaire
Measured: 2 months
Ease of activation of the device
The outcome is assessed by user questionnaire
Measured: 2 months
Quality of visual alert
The outcome is assessed by user questionnaire
Measured: 2 months
If the visual overlay disturbed polyp characterization
The outcome is assessed by user questionnaire
Measured: 2 months
Number of procedures used with an AI system, the one under the investigation
The outcome is assessed by user questionnaire
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start23 Aug 2022
- Primary completion26 Oct 2022
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augere Medical AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oslo University Hospital, Sahlgrenska University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519098
- Sponsor's protocol ID
- CIV-22-04-039386
- Status last verified
- Dec 2022
- First submitted
- 23 Aug 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COLO-SW-1 Clinical Investigation
- ClinicalTrials.gov ID
- NCT05519098
- Acronym / sponsor ID
- CIV-22-04-039386
- Conditions
- Colonoscopy, Adenoma Colon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Augere Medical ASIndustry (pharma, biotech, devices)
- Collaborators
- Oslo University Hospital, Sahlgrenska University Hospital
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inclusion group | – | Device: COLO-SW-1Patients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General population with a referral to colonoscopy.
Key inclusion criteria (2 listed)
- ≥18 years old
- Consenting to participate
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COLO-SW-1Patient will undergo a CADe-assisted colonoscopy procedure with use of the COLO-SW-1 software. | Device | Inclusion group |
Primary outcome
Number of adverse events (AE)
Time frame: 2 months
Number of technical problems disturbing the colonoscopy
Time frame: 2 months
1. Artifacts in the images on the endoscopy monitor 2. Degradation of the endoscopic image quality due to the device
Confirming compatibility to the endoscopic system
Time frame: 2 months
The outcome is assessed by user questionnaire
5 secondary outcomes
User manual understandability
Time frame: 2 months
Ease of activation of the device
Time frame: 2 months
Quality of visual alert
Time frame: 2 months
If the visual overlay disturbed polyp characterization
Time frame: 2 months
Number of procedures used with an AI system, the one under the investigation
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy and Adenoma Colon, run by Augere Medical AS at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (AE) (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.