- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06040710
Artificial-intelligence-based QUAntification of Size measuremeNts of Adenoma in Routine Endoscopy (AQUASNARE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective:
The primary aim of this study is to conduct a superiority analysis between POSEIDON and endoscopist optical estimation, focusing on the errors of polyp size measurement. Secondary objectives encompass subgroup analyses concerning varying polyp sizes and histology, potential impact on follow-up protocols based on polyp sizes, and determination of the percentage of cases where obtaining measurements with POSEIDON proves unfeasible.
Study Design:
Single center, endoscopist blinded study. Considering the results of the preliminary study, a total of 42 pairs of measurements suffices to extrapolate statistical significance for a power of 90% and a significance level of 0.05. Taking dropout rates, average number of polyps per patient, polyp detection rate, the number of patients expected to be enrolled for the study is 156. For obtaining the gold standard measurement, images from the examination recording where the tip of a snare is placed next to the polyp are extracted. The snare tip and polyp are manually segmented and their largest diameter in pixels is manually calculated. The diameter of the snare-tip will be measured after the examination to account for production based variations. Based on this, the gold standard polyp size is calculated.
AI setup and limitations:
The version of the polyp detection system, EndoMind, is an updated version of the one published in (PMID: 35543874). Notably, the POSEIDON method has undergone dual refinements from its first published version (PMID: 37080235). Firstly, the AI model for water-jet tip detection has been further trained using images from colonoscopy videos, leading to performance improvements. Secondly, the pixel-to-millimeter conversion methodology has been optimized to align with the specifications of the endoscopes employed in the trial.
To obtain a polyp size estimation, initially the polyp is detected by means of a bounding box through the EndoMind system. Then, once water-jet is sprayed next to the polyp, POSEIDON detects the tip of the water-jet, where it touches the mucosa. The coordinates of the tip in the endoscopic image are correlated to the distance of the endoscope to the mucosa. With the above, the largest diameter of the bounding box is converted from pixels to millimeters, resulting in the size estimation.
For measurement acquisition, the system is initiated at the beginning of the examination and deactivated at its conclusion, facilitated by a dedicated button press. Concerning expert-system interaction, the CADe system's identifications consistently appear on an auxiliary screen within the endoscopist's workspace. On this screen, precise visualization of the impact point between the water-jet beam and the mucosa follows water-jet detection. Subsequently, the endoscopist receives visual affirmation of a successful calculation of polyp size estimation, derived from the bounding box on the screen. The endoscopist evaluates the alignment of this box around the polyp to assess the accuracy measurement outcome. Importantly, throughout these operations, the endoscopist remains blinded to the size estimated by POSEIDON. The endoscopist also reports polyp cases where they are unable to obtain a proper measurement.
Study population:
All adult patients with screening or surveillance colonoscopies that do not match the exclusion criteria will be asked for informed consent.
Intervention:
Upon polyp identification by the endoscopist, the visual assessment will be conducted, followed by obtaining a satisfactory measurement using POSEIDON when possible, as described in the AI methods section. To eliminate potential learning bias and optimize efficiency, the examiner will be blinded to the immediate measurement result. Finally, after both measurements are obtained, an instrument tip of known size will be positioned adjacent to the polyp, which is to be later used for obtaining the gold-standard polyp size.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alexander Hann, Professor
- Phone Number: +49 931 201-45918
- Email: hann_a@ukw.de
Study Locations
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Bayern
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Würzburg, Bayern, Germany, 97080
- Universitätsklinikum Würzburg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients
- Scheduled for colonoscopy
Exclusion Criteria:
Patient Level:
- Inflammatory Bowel Disease
- Familiar Polyposis Syndrome
Data Level
- Failure to initialize system before examination
- Missing image instrument placed next to polyp to obtain gold standard
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Experimental: Intervention arm
All patients within the study are included in the intervention arm: polyp detected within these patients will be measured according to the study protocol using two different methods.
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Polyp size estimation using the POSEIDON software and bounding boxes of the EndoMind polyp detection system.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Error of size estimation for colorectal polyps using POSEIDON versus physician optical evaluation
Time Frame: Through study completion, an average of 5 months
|
The error between gold standard polyp size and estimation using POSEIDON and optical estimation will be compared in pairs for the same polyps.
|
Through study completion, an average of 5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of polyps where endoscopists failed to obtain POSEIDON measurement.
Time Frame: Through study completion, an average of 5 months
|
Evaluation of the percentage polyps for which the endoscopist was unable to obtain a proper measurement with the proposed method.
|
Through study completion, an average of 5 months
|
Error of size estimation for colorectal polyps using POSEIDON versus physician optical evaluation for different size categories
Time Frame: Through study completion, an average of 5 months
|
Polyps will be split into size categories based on national and international guidelines.
The study will assess the errors of both POSEIDON and optical estimation within each group through pairwise comparison
|
Through study completion, an average of 5 months
|
Error of size estimation for colorectal polyps using POSEIDON versus physician optical evaluation for polyps with different histologies
Time Frame: Through study completion, an average of 5 months
|
Polyps will be split into based on their histological evaluation.
The study will assess the errors of both POSEIDON and optical estimation within each group through pairwise comparison.
|
Through study completion, an average of 5 months
|
Rate of change in guideline-suggested follow-up interval based purely on detected polyp size.
Time Frame: Through study completion, an average of 5 months
|
The study determines follow-up intervals based on three international standards, solely considering polyp size estimated by the two methods.
|
Through study completion, an average of 5 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Lux 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.
- Sudarevic B, Sodmann P, Kafetzis I, Troya J, Lux TJ, Sassmannshausen Z, Herlod K, Schmidt SA, Brand M, Schottker K, Zoller WG, Meining A, Hann A. Artificial intelligence-based polyp size measurement in gastrointestinal endoscopy using the auxiliary waterjet as a reference. Endoscopy. 2023 Sep;55(9):871-876. doi: 10.1055/a-2077-7398. Epub 2023 Apr 20.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AI02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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