Surveillance Endoscopy for Colorectal CancerSMARTIENCT05006092
Surveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE)
A study testing ENDOMIND in people with Surveillance Endoscopy for Colorectal Cancer and Artificial Intelligence, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
Evaluation of an artificial intelligence system for polyp detection (CADe) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surveillance Endoscopy for Colorectal Cancer, Artificial Intelligence, Polyps of Colon
- What is being tested?
- ENDOMIND
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,149 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2021to 30 Nov 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- indication CRC surveillance endoscopy
- indication post-polypectomy surveillance endoscopy
- positive fecal immunochemical test in patients >=50 years
Who cannot join
- reasonable suspicion of inflammatory bowl disease
- reasonable suspicion of familiar polyposis Syndrome
- Patient after radiation/resection of colonic parts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Evaluation Study of the CADe System ENDOMIND in Surveillance Endoscopy for Colorectal Cancer in German Outpatient Cohort
Evaluation of an artificial intelligence system for polyp detection (CADe)
Read the detailed description
We aim to evaluate the artificial intelligence system ENDOMIND that supports endoscopist in detection of polyps during surveillance endoscopy for colorectal cancer. 1070 patients out of 6 gastroenterologic practice are randomized 1:1 for conventional surveillance colonoscopy vs. surveillance with AI support. Primary endpoint is Adenoma detection rate.
- Conditions
- Surveillance Endoscopy for Colorectal Cancer, Artificial Intelligence, Polyps of Colon, CADe
- Being tested
- ENDOMIND
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDOMINDDevice
CADe system for Polyp detection
| Study group | Role | What they receive |
|---|---|---|
| surveillance endoscopy with CADe support | Experimental | Endoscopy perfomed with CADe support. Receives: Device: ENDOMIND |
| conventional surveillance endoscopy | No intervention | Endoscopy perfomed without CADe support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate
proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas
Measured: 4 months
Secondary outcomes (4)
polyp detection rate
Exmainations with minimum one polyp detected.
Measured: 4 months
withdrawal time
Time of withdrawal.
Measured: 4 months
resection time
Time spent on polyp resections.
Measured: 4 months
Boston Bowl Preparation Score
minimum 0, Maximum 9; should be higher than 5 for appropriate surveillance
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 posted16 Aug 2021
- Study start1 Sep 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Surveillance Endoscopy for Colorectal CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Stuttgart
- Responsible party
- Sponsor
- Investigators
- Alexander Hann, Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006092
- Sponsor's protocol ID
- F-2021-047
- Acronym
- SMARTIE
- Status last verified
- Apr 2023
- First submitted
- 11 Jun 2021
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lux TJ, Sassmannshausen Z, Kafetzis I, Banck M, Krenzer A, Fitting D, Sudarevic B, Troya J, Boeck W, Passek F, Heubach T, Simonis B, Heil FJ, Ludwig L, Puppe F, Zoller WG, Meining A, Hann A. Artificial intelligence assisted colorectal lesion detection in private practices a randomized controlled study. NPJ Digit Med. 2026 Apr 1;9(1):284. doi: 10.1038/s41746-026-02576-8.
PubMed 41922731Lux TJ, Banck M, Sassmannshausen Z, Troya J, Krenzer A, Fitting D, Sudarevic B, Zoller WG, Puppe F, Meining A, Hann A. Pilot study of a new freely available computer-aided polyp detection system in clinical practice. Int J Colorectal Dis. 2022 Jun;37(6):1349-1354. doi: 10.1007/s00384-022-04178-8. Epub 2022 May 11.
PubMed 35543874
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Evaluation Study of the CADe System ENDOMIND in Surveillance Endoscopy for Colorectal Cancer in German Outpatient Cohort
- ClinicalTrials.gov ID
- NCT05006092
- Acronym / sponsor ID
- SMARTIE / F-2021-047
- Conditions
- Surveillance Endoscopy for Colorectal Cancer, Artificial Intelligence, Polyps of Colon, CADe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,149 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- Klinikum Stuttgart
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 16 Aug 2021 (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.
Evaluation of an artificial intelligence system for polyp detection (CADe)
Detailed description
We aim to evaluate the artificial intelligence system ENDOMIND that supports endoscopist in detection of polyps during surveillance endoscopy for colorectal cancer. 1070 patients out of 6 gastroenterologic practice are randomized 1:1 for conventional surveillance colonoscopy vs. surveillance with AI support. Primary endpoint is Adenoma detection rate.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surveillance endoscopy with CADe support | Experimental | Device: ENDOMINDEndoscopy perfomed with CADe support. |
| conventional surveillance endoscopy | No intervention | –Endoscopy perfomed without CADe support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- indication CRC surveillance endoscopy
- indication post-polypectomy surveillance endoscopy
- positive fecal immunochemical test in patients >=50 years
Key exclusion criteria (3 listed)
- reasonable suspicion of inflammatory bowl disease
- reasonable suspicion of familiar polyposis Syndrome
- Patient after radiation/resection of colonic parts
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 |
|---|---|---|
| ENDOMINDCADe system for Polyp detection | Device | surveillance endoscopy with CADe support |
Primary outcome
adenoma detection rate
Time frame: 4 months
proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas
4 secondary outcomes
polyp detection rate
Time frame: 4 months
withdrawal time
Time frame: 4 months
resection time
Time frame: 4 months
Boston Bowl Preparation Score
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 27 Apr 2023.
- Derived from this study: PubMed 41922731Lux TJ, Sassmannshausen Z, Kafetzis I, Banck M, Krenzer A, Fitting D, Sudarevic B, Troya J, Boeck W, Passek F, Heubach T, Simonis B, Heil FJ, Ludwig L, Puppe F, Zoller WG, Meining A, Hann A. Artificial intelligence assisted colorectal lesion detection in private practices a randomized controlled study. NPJ Digit Med. 2026 Apr 1;9(1):284. doi: 10.1038/s41746-026-02576-8.
- Derived from this study: PubMed 35543874Lux TJ, Banck M, Sassmannshausen Z, Troya J, Krenzer A, Fitting D, Sudarevic B, Zoller WG, Puppe F, Meining A, Hann A. Pilot study of a new freely available computer-aided polyp detection system in clinical practice. Int J Colorectal Dis. 2022 Jun;37(6):1349-1354. doi: 10.1007/s00384-022-04178-8. Epub 2022 May 11.
- 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.
Alexander Hann principal investigator
Wuerzburg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENDOMIND in people with Surveillance Endoscopy for Colorectal Cancer and Artificial Intelligence, run by Wuerzburg University Hospital at 1 site in Germany.
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 3 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 27 Apr 2023. 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 Germany. 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?
adenoma detection rate (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05006092, which also lists 2 linked publications.
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 27 Apr 2023.