- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06612606
Transfer Learning of a Neural Network for Robotic Surgical Assessment
Transfer Learning of a Pretrained Preclinical Neural Network for Robotic Surgical Assessment on Limited Clinical Data
The goal of this observational study is to explore how pretrained artificial intelligence (AI) models, trained on preclinical data, can improve the accuracy of action recognition and skills assessment in robot-assisted surgery (RAS) in urological patients by the use of transfer learning. The main questions it aims to answer are:
- Can pretrained AI models accurately assess action recognition and skills assessment in clinical surgeries?
- How do different training approaches of transfer learning affect the performance of the AI models? A baseline model developed from scratch using clinical data will be compared to pretrained models that are (1) directly applied to clinical data (2) fine-tuned by training only some layers of the AI model, and (3) fully retrained to see if these approaches improve performance.
Participants who are robot surgeons will:
- Undergo RAS procedures on patients, with no intervention, where video data will be collected for later action recognition and skills assessment.
- Contribute to model training and evaluation through clinical dataset integration.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Jutland
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Aalborg, North Jutland, Denmark, 9000
- Department of Urology, Aalborg University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study population consisted of robot surgeons who where either experienced or novice (being specialized doctors undergoing surgical fellowship to become robot surgeons).
All procedures where robot-assisted procedures done on patients, who were admitted for treatment at the urological department. The patients also gave their consent regarding data collection. However, the real participant where the robot surgeons.
Description
Inclusion Criteria:
- Robot surgeons who are experienced with more than 100 cases.
- Robot surgical fellows with less than 100 cases.
- Robot surgeons who worked at the urological department of Aalborg University Hospital.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Experienced robot surgeons
Robot surgeons with 100 or more performed robot surgical cases.
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This was an observational study with no intervention.
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Novice robot surgeons
Robot surgeons with less than 100 performed robot surgical cases.
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This was an observational study with no intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Accuracy of action recognition using clinical data from scratch
Time Frame: From start to end of a the robot surgical procedure that is being assessed in terms of action recognition.
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Accuracy of the deep learning algorithm for action recognition, when training the model from scratch using clinical data from robot surgical procedures.
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From start to end of a the robot surgical procedure that is being assessed in terms of action recognition.
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Accuracy of skills assessment using clinical data from scratch
Time Frame: From start to end of a the robot surgical procedure that is being assessed in terms of action recognition.
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Accuracy of the deep learning algorithm for skills assessment, when training the model from scratch using clinical data from robot surgical procedures.
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From start to end of a the robot surgical procedure that is being assessed in terms of action recognition.
|
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Accuracy of action recognition using the pretrained network directly on clinical data
Time Frame: From start to end of a the robot surgical procedure that is being assessed in terms of action recognition.
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Accuracy of the pretrained deep learning algorithm for action recognition, when using the model directly on clinical data from robot surgical procedures.
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From start to end of a the robot surgical procedure that is being assessed in terms of action recognition.
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Accuracy of skills assessment using the pretrained model directly on clinical data
Time Frame: From start to end of a the robot surgical procedure that is being assessed in terms of skills assessment.
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Accuracy of the pretrained deep learning algorithm for skills assessment, when using the model directly on clinical data from robot surgical procedures.
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From start to end of a the robot surgical procedure that is being assessed in terms of skills assessment.
|
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K fold accuracies for action recognition and skills assessment for the complete retraining of the pretrained network.
Time Frame: From the start to the end of the clinical procedures.
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K fold cross-validation accuracies when retraining the complete pretrained model on the clinical data for both action recognition and skills assessment.
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From the start to the end of the clinical procedures.
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K fold accuracies for action recognition and skills assessment for the partial retraining of the pretrained network.
Time Frame: From the start to the end of the clinical procedures.
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K fold cross validation accuracies for action recognition and skills assessment for the retraining of the LSTM and dense layers of the pretrained network using clinical data.
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From the start to the end of the clinical procedures.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Weighted recall/sensitivity, precision and F1 score for action recognition of the clinical network trained from scratch
Time Frame: From start to end of a the robot surgical procedure that is being assessed in terms of action recognition.
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Based on the performance of action recognition from the clinical network trained from scratch.
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From start to end of a the robot surgical procedure that is being assessed in terms of action recognition.
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Weighted recall/sensitivity, precision and F1 score for Skills Assessment of the clinical network trained from scratch
Time Frame: From start to end of a the robot surgical procedure that is being assessed in terms of skills assessment..
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Based on the performance of skills assessment from the clinical network trained from scratch.
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From start to end of a the robot surgical procedure that is being assessed in terms of skills assessment..
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Predictive certainty of the action recognition and skills assessment of the network trained from scratch on the clinical data.
Time Frame: From the start to the end of the clinical procedures.
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Predictive certainty with overall mean, minimum and maximum and depicted in probability plots for action recognition and skills assessment of the network trained from scratch on clinical data.
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From the start to the end of the clinical procedures.
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Predictive certainty of the action recognition and skills assessment of the network partially retrained network.
Time Frame: From the start to the end of the clinical procedures.
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Predictive certainty with overall mean, minimum and maximum and depicted in probability plots for action recognition and skills assessment of the partially retrained network, where only the LSTM and deep layers of the network was trained on clinical data.
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From the start to the end of the clinical procedures.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- 2021-247
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The IPD will be shared as anonymous and GDPR secure data on an open access website.
The data will be shared as the anonymized footage of the surgical procedures that the participants made.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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