LaparoscopyLARANCT05389241
Laparoscopic Augmented Reality for Identification of Liver Lesions - a Pre-clinical Randomized Cross-over Trial
A study testing Method A and Method B in people with Laparoscopy and Augmented Reality, run by Universitätsklinikum Köln at 1 site in Germany.
Trial summary
Procedure preparation and accurate knowledge of the specific anatomy is an integral part of performing minimally invasive procedures. Due to the complexity with high variability and the non-visibility of the vascular structures, the liver poses a particular challenge. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laparoscopy, Augmented Reality, Orientation, Spatial
- What is being tested?
- Method A and Method B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2022to 1 Mar 2024
- 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
- medical student of University of Cologne OR medical doctor in a surgical specialty
- informed consent signed
Who cannot join
- known and not correctable deficit of stereoscopic view
- for medical students: experience with laparoscopy or laparoscopy simulators
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Cologne, Department of General, Visceral and Cancer Surgery
Cologne, 50931
About this study
Official title: Monocentric Prospective Randomized Study on the Influence of On-screen Use of a Virtual 3-dimensional Liver Model Reconstructed From CT Data on Spatial Perception During Laparoscopy on the Liver Phantom.
Procedure preparation and accurate knowledge of the specific anatomy is an integral part of performing minimally invasive procedures. Due to the complexity with high variability and the non-visibility of the vascular structures, the liver poses a particular challenge.
Therefore medical students and experienced surgeons will receive standardized, structured training on liver anatomy, the use of laparoscopic ultrasound and the application and use of CT data sets and the virtual 3D liver model. This training will be evaluated by questionnaires. Both groups then carry out a series of localization exercises on an artificial liver phantom: tumor imitations, which are displayed in the image(3D virtaul mdoel or 2D-CT-Data-Set), have to be found in the liver phantom laparoscopically using ultrasound.
Read more
In each round, different scenarios are worked on, once without and then with the support of the virtual 3D liver model. The virtual 3D model can be displayed directly on the laparoscopic monitor using a display software specially developed for the trial and can be manipulated by the subjects.
The aim of the study is to provide evidence that the availability and use of a virtual 3D model (augmented reality) leads to a significantly improved spatial perception of the subjects during laparoscopy of the liver. In addition, the subjectively perceived cognitive load of the subjects during the test run with and without the support of the virtual 3D model is surveyed and the learning success is evaluated.
Read the detailed description
Procedure preparation and accurate knowledge of the specific anatomy is an integral part of performing a minimally invasive procedure. Due to the complexity with high variability and the non-visibility of the vascular structures due to the location in the parenchyma, the liver poses a particular challenge. The spatial perception and cognitive processing of the anatomical target structures is of particular importance.
The aim of this study is to test the hypothesis that the use of a 3-dimensional (3D) virtual liver model (virtual 3D model crating augmented reality) presenedt on teh laparoscopic screeen reconstructed from CT data exerts an influence on the spatial perception of subjects during laparoscopy on the liver phantom.
After informed consent and consent to the study, a pseudonymised subject population consisting of surgeons with experience in laparoscopy (n=36) and an equal number of medical students without experience in laparoscopy (n=36) will be included in the study included. The subjects will be randomized and divided into two groups of equal size, stratified according to experience in laparoscopy. The randomization is carried out by a data trustee. All subjects then receive standardized, structured training on liver anatomy, the use of laparoscopic ultrasound, and the application and use of CT data sets and the virtual 3D liver model. This is evaluated by means of a questionnaire. Both groups then sequentially carry out a defined series of localization exercises on an artificial liver phantom: tumor imitations, which are displayed in the image, have to be found in the liver phantom laparoscopically using ultrasound. In each round, different scenarios are worked on once without and then with the support of the virtual 3D liver model. The virtual 3D model can be displayed directly on the laparoscopic monitor using display software specially made for the study and can be manipulated by the subjects. The aim of the study is to provide evidence that the availability and use of a virtual 3D model leads to a significantly improved spatial perception of the subjects during laparoscopy of the liver. In addition, the subjectively perceived cognitive load of the subjects during the test run with and without the support of the virtual 3D model is surveyed by NASA Task Load Index and the learning success is evaluated.
The primary endpoints of the study are the number of correctly spatially identified target structures and the time required to localize the given target structures.
- Conditions
- Laparoscopy, Augmented Reality, Orientation, Spatial, Liver
- Being tested
- Method A, Method B
- Keywords
- Augmented reality, liver, minimally invasive surgery, laparoscopy, 3D, spatial orientation, digital health, artificial intelligence
- Medical subject headings
- Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Method AOther
The subjects will perform tasks on the liver phantom (identification of target lesions). They will perform the tasks with Method A (2D-CT) or Method B (2D-CT + 3D augmented reality model). the intervention type Method A means that the trainings set up is performed first with Method A an after that with Method B.
Method BOther
The subjects will perform tasks on the liver phantom (identifikation of target lesions). They will perform the tasks with Method A (2D-CT) or Method B (2D-CT + 3D augmented reality model). the intervention type Method B means that the trainings set up is performed first with Method B an after that with Method A.
| Study group | Role | What they receive |
|---|---|---|
| Method A | Experimental | Subjects in this arm will perform the task on the liver phantom with Method A (2D-CT). Then they will do the NASA task load index questionnaire. After that they will perform the tasks with Method B (2D-CT + 3D augmented reality model). After that again a NASA Task load index questionnaire is performed Receives: Other: Method A |
| Method B | Experimental | Subjects in this arm will perform the task on the liver phantom with method B (2D-CT + 3D augmented reality model). Then they will do the NASA task load index questionnaire. After that they will perform the tasks with Method A (2D-CT). After that again a NASA Task load index questionnaire is performed Receives: Other: Method B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of correctly identified targets
The number of correctly spatially identified targets (tumors in the liver phantom)
Measured: immediately after tasks are performed, Day 1
Time required
The time required to localize the specified target structures (tumors in the live phantom)
Measured: immediately after tasks are performed, Day 1
Secondary outcomes (3)
Task Load Index
The specific cognitive effort of the subject (measured using the NASA Task Load Index)
Measured: immediately after tasks are performed, Day 1
Modification of procedure planning
The modification of the initially prepared procedure planning when the virtual 3D model is available
Measured: immediately after tasks are performed with both methods, Day 1
Learning curve
Qualitative evaluation of the learning curve and success of the subjects
Measured: immediately after tasks are performed with both methods, Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Köln
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roger Wahba, MD, PhD, Universitätsklinikum Köln
- Investigators
- Roger Wahba, MD, PHD, Principal investigator, Universitätsklinikum Köln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389241
- Sponsor's protocol ID
- 21-1406
- Acronym
- LARA
- Status last verified
- Aug 2022
- First submitted
- 19 May 2022
- Last updated
- 16 Aug 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 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Prospective Randomized Study on the Influence of On-screen Use of a Virtual 3-dimensional Liver Model Reconstructed From CT Data on Spatial Perception During Laparoscopy on the Liver Phantom.
- ClinicalTrials.gov ID
- NCT05389241
- Acronym / sponsor ID
- LARA / 21-1406
- Conditions
- Laparoscopy, Augmented Reality, Orientation, Spatial, Liver
- Keywords
- Augmented reality, liver, minimally invasive surgery, laparoscopy, 3D, spatial orientation, digital health, artificial intelligence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Universitätsklinikum KölnUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 25 May 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.
Procedure preparation and accurate knowledge of the specific anatomy is an integral part of performing minimally invasive procedures. Due to the complexity with high variability and the non-visibility of the vascular structures, the liver poses a particular challenge.
Therefore medical students and experienced surgeons will receive standardized, structured training on liver anatomy, the use of laparoscopic ultrasound and the application and use of CT data sets and the virtual 3D liver model. This training will be evaluated by questionnaires. Both groups then carry out a series of localization exercises on an artificial liver phantom: tumor imitations, which are displayed in the image(3D virtaul mdoel or 2D-CT-Data-Set), have to be found in the liver phantom laparoscopically using ultrasound.
In each round, different scenarios are worked on, once without and then with the support of the virtual 3D liver model. The virtual 3D model can be displayed directly on the laparoscopic monitor using a display software specially developed for the trial and can be manipulated by the subjects.
The aim of the study is to provide evidence that the availability and use of a virtual 3D model (augmented reality) leads to a significantly improved spatial perception of the subjects during laparoscopy of the liver. In addition, the subjectively perceived cognitive load of the subjects during the test run with and without the support of the virtual 3D model is surveyed and the learning success is evaluated.
Detailed description
Procedure preparation and accurate knowledge of the specific anatomy is an integral part of performing a minimally invasive procedure. Due to the complexity with high variability and the non-visibility of the vascular structures due to the location in the parenchyma, the liver poses a particular challenge. The spatial perception and cognitive processing of the anatomical target structures is of particular importance.
The aim of this study is to test the hypothesis that the use of a 3-dimensional (3D) virtual liver model (virtual 3D model crating augmented reality) presenedt on teh laparoscopic screeen reconstructed from CT data exerts an influence on the spatial perception of subjects during laparoscopy on the liver phantom.
After informed consent and consent to the study, a pseudonymised subject population consisting of surgeons with experience in laparoscopy (n=36) and an equal number of medical students without experience in laparoscopy (n=36) will be included in the study included. The subjects will be randomized and divided into two groups of equal size, stratified according to experience in laparoscopy. The randomization is carried out by a data trustee. All subjects then receive standardized, structured training on liver anatomy, the use of laparoscopic ultrasound, and the application and use of CT data sets and the virtual 3D liver model. This is evaluated by means of a questionnaire. Both groups then sequentially carry out a defined series of localization exercises on an artificial liver phantom: tumor imitations, which are displayed in the image, have to be found in the liver phantom laparoscopically using ultrasound. In each round, different scenarios are worked on once without and then with the support of the virtual 3D liver model. The virtual 3D model can be displayed directly on the laparoscopic monitor using display software specially made for the study and can be manipulated by the subjects. The aim of the study is to provide evidence that the availability and use of a virtual 3D model leads to a significantly improved spatial perception of the subjects during laparoscopy of the liver. In addition, the subjectively perceived cognitive load of the subjects during the test run with and without the support of the virtual 3D model is surveyed by NASA Task Load Index and the learning success is evaluated.
The primary endpoints of the study are the number of correctly spatially identified target structures and the time required to localize the given target structures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Method A | Experimental | Other: Method ASubjects in this arm will perform the task on the liver phantom with Method A (2D-CT). Then they will do the NASA task load index questionnaire. After that they will perform the tasks with Method B (2D-CT + 3D augmented reality model). After that again a NASA Task load index questionnaire is performed |
| Method B | Experimental | Other: Method BSubjects in this arm will perform the task on the liver phantom with method B (2D-CT + 3D augmented reality model). Then they will do the NASA task load index questionnaire. After that they will perform the tasks with Method A (2D-CT). After that again a NASA Task load index questionnaire is performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- medical student of University of Cologne OR medical doctor in a surgical specialty
- informed consent signed
Key exclusion criteria (2 listed)
- known and not correctable deficit of stereoscopic view
- for medical students: experience with laparoscopy or laparoscopy simulators
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 |
|---|---|---|
| Method AThe subjects will perform tasks on the liver phantom (identification of target lesions). They will perform the tasks with Method A (2D-CT) or Method B (2D-CT + 3D augmented reality model). the intervention type Method A means that the trainings set up is performed first with Method A an after that with Method B. | Other | Method A |
| Method BThe subjects will perform tasks on the liver phantom (identifikation of target lesions). They will perform the tasks with Method A (2D-CT) or Method B (2D-CT + 3D augmented reality model). the intervention type Method B means that the trainings set up is performed first with Method B an after that with Method A. | Other | Method B |
Primary outcome
Number of correctly identified targets
Time frame: immediately after tasks are performed, Day 1
The number of correctly spatially identified targets (tumors in the liver phantom)
Time required
Time frame: immediately after tasks are performed, Day 1
The time required to localize the specified target structures (tumors in the live phantom)
3 secondary outcomes
Task Load Index
Time frame: immediately after tasks are performed, Day 1
Modification of procedure planning
Time frame: immediately after tasks are performed with both methods, Day 1
Learning curve
Time frame: immediately after tasks are performed with both methods, Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 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.
Roger Wahba, MD, PHD principal investigator
Universitätsklinikum Köln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Method A and Method B in people with Laparoscopy and Augmented Reality, run by Universitätsklinikum Köln 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roger Wahba, MD, PHD (+492214784803, roger.wahba@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of correctly identified targets (time frame: immediately after tasks are performed, Day 1). The study lists 2 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 Aug 2022.