Polyp of ColonNCT04378660
Artificial Intelligence (AI) Validation Study for Polyp Detection
A study testing Artificial intelligence for polyp detection in people with Polyp of Colon, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Interventional prospective multicenter study: Polyp detection by an automated endoscopic tool as second observer during routine diagnostic colonoscopy Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polyp of Colon
- What is being tested?
- Artificial intelligence for polyp detection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Oct 2019to 18 Apr 2020
- Phase
- Interventional
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- > 18 years
- Diagnostic or screening colonoscopy
- Therapeutic colonoscopy
Who cannot join
- Inability to give informed consent by the patient or legal representative
- < 18 years old
- Any contraindication for colonoscopy or biopsies of the colon
- Uncontrolled coagulopathy
- Confirmed diagnosis of inflammatory bowel disease
- Short bowel or ileostomy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Artificial Intelligence Validation Trial for Polyp Detection: Pilot Study
Interventional prospective multicenter study: Polyp detection by an automated endoscopic tool as second observer during routine diagnostic colonoscopy
Read the detailed description
This is an investigator-initiated multicentre non-randomized prospective interventional trial to validate the performance of a novel state-of-the-art computer-aided diagnostic (CAD) tool in polyp detection implemented as second observer during routine diagnostic colonoscopy and to evaluate its feasibility in daily endoscopy. Patients referred for a screening surveillance or therapeutic colonoscopy will undergo a colonoscopy performed by an endoscopist with moderate to high adenoma detection rate (ADR > 20% and < 50%) while a second observer will follow the procedure on a bedside AI-tool to count the number of detections made by the AI system and categorize the results into positive or negative results as follows (1) true positive, (2) false negative, (3) other positive and (4) obvious false positive. When a doubtful detection is made by the AI-system, the second observer will ask to re-evaluate the indicated region. When the detection is clear, the endoscopist and second observer do not communicate. The entire procedure is recorded.
- Conditions
- Polyp of Colon
- Being tested
- Artificial intelligence for polyp detection
- Keywords
- Colonic polyp, Artificial intelligence, Second observer
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intelligence for polyp detectionDiagnostic test
Colonoscopy enriched with artificial intelligence tool developed for polyp detection, implemented as a second observer
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Colonoscopy with AI Receives: Diagnostic Test: Artificial intelligence for polyp detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the novel AI system compared to endoscopic diagnosis as gold standard
Determination of the diagnostic accuracy of the novel AI system as second observer
Measured: 4 months
Secondary outcomes (1)
Endoscopist's polyp miss rate as number of extra AI detections
Determination of the AI system's precision and extra value as second observer
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start30 Oct 2019
- Primary completion18 Apr 2020
- Study completion18 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyp of ColonStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Nuovo Regina Margherita Hospital, Rome, Italy, Universitäts Medizin, Mainz, Germany
- Responsible party
- Sponsor
- Investigators
- Raf Bisschops, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378660
- Sponsor's protocol ID
- s59405
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We don't share any patient information with other researchers, nor when it's anonymized
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Validation Trial for Polyp Detection: Pilot Study
- ClinicalTrials.gov ID
- NCT04378660
- Acronym / sponsor ID
- s59405
- Conditions
- Polyp of Colon
- Keywords
- Colonic polyp, Artificial intelligence, Second observer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Nuovo Regina Margherita Hospital, Rome, Italy, Universitäts Medizin, Mainz, Germany
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 18 Apr 2020 (actual)
- Study completion
- 18 Apr 2020 (actual)
- First posted
- 7 May 2020 (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.
Interventional prospective multicenter study: Polyp detection by an automated endoscopic tool as second observer during routine diagnostic colonoscopy
Detailed description
This is an investigator-initiated multicentre non-randomized prospective interventional trial to validate the performance of a novel state-of-the-art computer-aided diagnostic (CAD) tool in polyp detection implemented as second observer during routine diagnostic colonoscopy and to evaluate its feasibility in daily endoscopy. Patients referred for a screening surveillance or therapeutic colonoscopy will undergo a colonoscopy performed by an endoscopist with moderate to high adenoma detection rate (ADR > 20% and < 50%) while a second observer will follow the procedure on a bedside AI-tool to count the number of detections made by the AI system and categorize the results into positive or negative results as follows (1) true positive, (2) false negative, (3) other positive and (4) obvious false positive. When a doubtful detection is made by the AI-system, the second observer will ask to re-evaluate the indicated region. When the detection is clear, the endoscopist and second observer do not communicate. The entire procedure is recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Diagnostic Test: Artificial intelligence for polyp detectionColonoscopy with AI |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- > 18 years
- Diagnostic or screening colonoscopy
- Therapeutic colonoscopy
Key exclusion criteria (7 listed)
- Inability to give informed consent by the patient or legal representative
- < 18 years old
- Any contraindication for colonoscopy or biopsies of the colon
- Uncontrolled coagulopathy
- Confirmed diagnosis of inflammatory bowel disease
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 |
|---|---|---|
| Artificial intelligence for polyp detectionColonoscopy enriched with artificial intelligence tool developed for polyp detection, implemented as a second observer | Diagnostic test | Intervention arm |
Primary outcome
Diagnostic accuracy of the novel AI system compared to endoscopic diagnosis as gold standard
Time frame: 4 months
Determination of the diagnostic accuracy of the novel AI system as second observer
1 secondary outcome
Endoscopist's polyp miss rate as number of extra AI detections
Time frame: 4 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 7 May 2020.
- Individual participant dataSharing planned: No. We don't share any patient information with other researchers, nor when it's anonymized
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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.
Raf Bisschops principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial intelligence for polyp detection in people with Polyp of Colon, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 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 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Diagnostic accuracy of the novel AI system compared to endoscopic diagnosis as gold standard (time frame: 4 months). 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 7 May 2020.