Predictive Validity of VLaHHS(VLaHHS)NCT06974383
Development and Validation of Virtual Laparoscopic Hiatal Hernia Simulator
A study testing Training with Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS) in people with Predictive Validity of VLaHHS, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Part 3 Phase III of this protocol is the interventional portion and is the reason why only this Part is registered and reported within this record. The goal of this phase of the study is to establish the learning curve and predictive validity of the VLaHHS. The study population includes GS residents. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Predictive Validity of VLaHHS
- What is being tested?
- Training with Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General Surgery (GS) residents
Who cannot join
- Residents other than GS
- Participants who are not residents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS)
Part 3 Phase III of this protocol is the interventional portion and is the reason why only this Part is registered and reported within this record. The goal of this phase of the study is to establish the learning curve and predictive validity of the VLaHHS. The study population includes GS residents.
The hypothesis is that the subject trained in VLaHHS will improve their skills compared to control with no training and show better transfer of skills on to an actual procedure.
Read the detailed description
The learning curve of VLaHHS will be established by training subjects in the task over extended period until they reach a plateau. The predictive validity will be established by comparing the training group with a control group with no training by testing their skills on a simulated surgical task using a crural repair silicone model and porcine fundoplication model.
The experimental design is a between-subjects design with two groups to which participants will be randomly assigned: (1) Group 1 (Simulation Group): training with VLaHHS, (2) Group 2 (Control Group): no training. The Crural closure tasks of VLaHHS will be tested (10 subjects per task). Before the testing session begins, all participants will receive a guided, hands-on orientation to the task that is being tested. They will then take a pre-test in which they will be asked to perform the task once to mark their baseline performance (i.e. initialize their learner profile). For the training phase, participants in Group 1 will perform the tasks on VLaHHS for an hour a day for a maximum of no more than three weeks (3 weeks' x 5 days = 15 sessions). In each session of no more than an hour, subjects will repeat the task five times.
Participants in Group 2 will continue with their normal residency training but will not participate in VLaHHS training at all.
Two aspects of learning will then be assessed post-training: skill learning and transfer-of-training. For the Simulation Group, skill learning will be measured immediately following training (post-test) and again after two weeks to measure retention. For the Control Group, skill learning will be measured four weeks after orientation and again two weeks later to measure retention. Finally, immediately after post-test, transfer-of-training will be assessed using simulated crural repair or fundoplication model. The transfer study will be conducted either at the UT Southwestern (UTSW) Simulation Center or at the Artificial Intelligence and Medical Simulation (AIMS) Lab in south campus.
Dependent measures for learning curve and retention will be the score computed from completion time and errors on the VLaHHS and the workload assessment measured using the NASA-TLX (Task Load Index) questionnaire after each session. For the transfer task, Subjects performance on the crural repair task will be video recorded and evaluated by a minimum of three experts using Global Assessment Tools for Intraoperative Laparoscopic Skills (GOALS) subjective evaluation method.
The videotaping will focus only on subjects hand and any Identifying information such as subjects face will not be captured.
- Conditions
- Predictive Validity of VLaHHS
- Being tested
- Training with Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS)
- Keywords
- Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS), GS Residents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training with Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS)Other
For the training phase, participants in Group 1 will perform the tasks on VLaHHS for an hour a day for a maximum of 15 sessions over 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Simulation Group) | Experimental | Training with VLaHHS. Before the testing session begins, all participants will receive a guided, hands-on orientation to the task that is being tested. They will then take a pre-test in which they will be asked to perform the task once to mark their baseline performance (i.e. initialize their learner profile). Receives: Other: Training with Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS) |
| Group 2 (Control Group) | No intervention | No training with VLaHHS. Before the testing session begins, all participants will receive a guided, hands-on orientation to the task that is being tested. They will then take a pre-test in which they will be asked to perform the task once to mark their baseline performance (i.e. initialize their learner profile). They will continue with their normal residency training but will not participate in VLaHHS training at all. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skill Level in Participants as Assessed by Completion Time
Dependent measures for learning curve will be assessed by completion time.
Measured: Baseline (at pre-test)
Skill Level in Participants Assessed by Numerical Performance Score on the VLaHHS
Dependent measures for learning curve will be assessed by numerical score computed based on performance on the VLaHHS. The performance was assessed based on the following metrics with possible scores in parenthesis:
- Created Equidistant Sutures (0,3,5)
- Smooth Tool Handling (0,3,5)
- Respect for Tissue (0, 3, 5)
- Created All Full Thickness Bites (0, 3, 5)
- Performed Correct In-Out Sequence of suturing (0, 3, 5)
- Did Not Collided with Esophagus (0, 3, 5)
- Created Correct Amount of Knots (0, 3, 5)
- Tightened All Knots (0,3,5)
- Correctly Performed Slipknots (0, 3, 5).
The final numerical score is the sum of all individual performance measures which can range from a minimum of 0 to a maximum of 45. Higher score denotes better performance.
Measured: Baseline (at pre-test)
Skill Level in Participants Assessed by NASA-TLX Questionnaire
Dependent measures for learning curve will be measured using the NASA-TLX questionnaire. The NASA Task Load Index (NASA-TLX) is a tool to subjectively assess cognitive and emotional load during a simulation. Students rate six dimensions: mental and physical demands, time pressure, performance, effort, and frustration. Each dimension is assessed on a scale of 0-10, with a possible total score range of 0 to 60. A higher value indicates a higher burden.
Measured: Baseline (at pre-test)
Skill Level in Participants as Assessed by Completion Time
Dependent measures for learning curve will be assessed by completion time of the participants on the VLAHHS Crural Repair task.
Measured: Immediately post test (three weeks after pre-test)
Skill Level in Participants Assessed by Numerical Performance Score on the VLaHHS
Dependent measures for learning curve will be assessed by numerical score computed based on performance on the VLaHHS. The performance was assessed based on the following metrics with possible scores in parenthesis,
- Created Equidistant Sutures (0,3,5)
- Smooth Tool Handling (0,3,5)
- Respect for Tissue (0, 3, 5)
- Created All Full Thickness Bites (0, 3, 5)
- Performed Correct In-Out Sequence of suturing (0, 3, 5)
- Did Not Collided with Esophagus (0, 3, 5)
- Created Correct Amount of Knots (0, 3, 5)
- Tightened All Knots (0,3,5)
- Correctly Performed Slipknots (0, 3, 5).
The final numerical score is the sum of all individual performance measures which can range from a minimum of 0 to a maximum of 45. Higher score denotes better performance.
Measured: Immediately post test (three weeks after pre-test)
Skill Level in Participants Assessed by NASA-TLX Questionnaire
Dependent measures for learning curve will be measured using the NASA-TLX questionnaire. The NASA Task Load Index (NASA-TLX) is a tool to subjectively assess cognitive and emotional load during a simulation. Students rate six dimensions: mental and physical demands, time pressure, performance, effort, and frustration. Each dimension is assessed on a scale of 0-10, with a possible total score range of 0 to 60. A higher value indicates a higher burden.
Measured: Immediately post test (three weeks after pre-test)
Skill Retention in Participants as Assessed by Completion Time
Dependent measures will be assessed by completion time of participants on the VLAHHS Crural repair task.
Measured: 2 weeks after post test
Skill Level in Participants Assessed by Numerical Performance Scale on the VLaHHS
Dependent measures for learning curve will be assessed by numerical score computed based on performance on the VLaHHS. The performance was assessed based on the following metrics with possible scores in parenthesis,
- Created Equidistant Sutures (0,3,5)
- Smooth Tool Handling (0,3,5)
- Respect for Tissue (0, 3, 5)
- Created All Full Thickness Bites (0, 3, 5)
- Performed Correct In-Out Sequence of suturing (0, 3, 5)
- Did Not Collided with Esophagus (0, 3, 5)
- Created Correct Amount of Knots (0, 3, 5)
- Tightened All Knots (0,3,5)
- Correctly Performed Slipknots (0, 3, 5).
The final numerical score is the sum of all individual performance measures which can range from a minimum of 0 to a maximum of 45. Higher score denotes better performance.
Measured: 2 weeks after post test
Skill Retention in Participants as Assessed by NASA-TLX Questionnaire
Dependent measures for learning curve will be measured using the NASA-TLX questionnaire. The NASA Task Load Index (NASA-TLX) is a tool to subjectively assess cognitive and emotional load during a simulation. Students rate six dimensions: mental and physical demands, time pressure, performance, effort, and frustration. Each dimension is assessed on a scale of 0-10, with a possible total score range of 0 to 60. A higher value indicates a higher burden.
Measured: 2 weeks after post test
Transfer of Skill in Participants as Assessed by Performance Score
This measure will be assessed using a performance score assessed using a modified tool that consists of Global Assessment Tools for Intraoperative Laparoscopic Skills (GOALS) domains and task-specific metrics. The individual assessment items and their possible scores are:
- Depth perception (0,3,5)
- Bimanual dexterity (0,3,5)
- Efficiency (0,3,5)
- Tissue handling (0,3,5)
- Knowledge of procedure (0,3,5)
- Flow of operation (0,3,5)
- Instrument handling (0,3,5)
- Bite size (0,3,5)
- Knot tying (0,3,5)
- Needle handling (0,3,5)
- Crural repair closure (0,3,5)
- Tissue bites (0,3,5)
The total range for the transfer of skills score will be 0-60 with higher score indicating better performance.
Measured: Immediately post test (three weeks after pre-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start23 Apr 2025
- Primary completion30 Jun 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Predictive Validity of VLaHHSStudies 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
- Parallel groups
- Model description
- Participants will be randomly assigned to 2 groups - simulation group \& Control group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Principal investigator, Ganesh Sankaranarayanan, University of Texas Southwestern Medical Center
- Investigators
- Ganesh Sankaranarayanan, Ph.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974383
- Sponsor's protocol ID
- STU-2021-0151
- Other IDs
- 1R01EB025247-01A1
- Acronym
- (VLaHHS)
- Status last verified
- Apr 2026
- First submitted
- 7 May 2025
- Last updated
- 19 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS)
- ClinicalTrials.gov ID
- NCT06974383
- Acronym / sponsor ID
- (VLaHHS) / STU-2021-0151
- Conditions
- Predictive Validity of VLaHHS
- Keywords
- Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS), GS Residents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 15 May 2025 (actual)
- Results
- Posted 19 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Part 3 Phase III of this protocol is the interventional portion and is the reason why only this Part is registered and reported within this record. The goal of this phase of the study is to establish the learning curve and predictive validity of the VLaHHS. The study population includes GS residents.
The hypothesis is that the subject trained in VLaHHS will improve their skills compared to control with no training and show better transfer of skills on to an actual procedure.
Detailed description
The learning curve of VLaHHS will be established by training subjects in the task over extended period until they reach a plateau. The predictive validity will be established by comparing the training group with a control group with no training by testing their skills on a simulated surgical task using a crural repair silicone model and porcine fundoplication model.
The experimental design is a between-subjects design with two groups to which participants will be randomly assigned: (1) Group 1 (Simulation Group): training with VLaHHS, (2) Group 2 (Control Group): no training. The Crural closure tasks of VLaHHS will be tested (10 subjects per task). Before the testing session begins, all participants will receive a guided, hands-on orientation to the task that is being tested. They will then take a pre-test in which they will be asked to perform the task once to mark their baseline performance (i.e. initialize their learner profile). For the training phase, participants in Group 1 will perform the tasks on VLaHHS for an hour a day for a maximum of no more than three weeks (3 weeks' x 5 days = 15 sessions). In each session of no more than an hour, subjects will repeat the task five times.
Participants in Group 2 will continue with their normal residency training but will not participate in VLaHHS training at all.
Two aspects of learning will then be assessed post-training: skill learning and transfer-of-training. For the Simulation Group, skill learning will be measured immediately following training (post-test) and again after two weeks to measure retention. For the Control Group, skill learning will be measured four weeks after orientation and again two weeks later to measure retention. Finally, immediately after post-test, transfer-of-training will be assessed using simulated crural repair or fundoplication model. The transfer study will be conducted either at the UT Southwestern (UTSW) Simulation Center or at the Artificial Intelligence and Medical Simulation (AIMS) Lab in south campus.
Dependent measures for learning curve and retention will be the score computed from completion time and errors on the VLaHHS and the workload assessment measured using the NASA-TLX (Task Load Index) questionnaire after each session. For the transfer task, Subjects performance on the crural repair task will be video recorded and evaluated by a minimum of three experts using Global Assessment Tools for Intraoperative Laparoscopic Skills (GOALS) subjective evaluation method.
The videotaping will focus only on subjects hand and any Identifying information such as subjects face will not be captured.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to 2 groups - simulation group \& Control group
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Simulation Group) | Experimental | Other: Training with Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS)Training with VLaHHS. Before the testing session begins, all participants will receive a guided, hands-on orientation to the task that is being tested. They will then take a pre-test in which they will be asked to perform the task once to mark their baseline performance (i.e. initialize their learner profile). |
| Group 2 (Control Group) | No intervention | –No training with VLaHHS. Before the testing session begins, all participants will receive a guided, hands-on orientation to the task that is being tested. They will then take a pre-test in which they will be asked to perform the task once to mark their baseline performance (i.e. initialize their learner profile). They will continue with their normal residency training but will not participate in VLaHHS training at all. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- General Surgery (GS) residents
Key exclusion criteria (2 listed)
- Residents other than GS
- Participants who are not residents.
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 |
|---|---|---|
| Training with Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS)For the training phase, participants in Group 1 will perform the tasks on VLaHHS for an hour a day for a maximum of 15 sessions over 3 weeks. | Other | Group 1 (Simulation Group) |
Primary outcome
Skill Level in Participants as Assessed by Completion Time
Time frame: Baseline (at pre-test)
Dependent measures for learning curve will be assessed by completion time.
Skill Level in Participants Assessed by Numerical Performance Score on the VLaHHS
Time frame: Baseline (at pre-test)
Dependent measures for learning curve will be assessed by numerical score computed based on performance on the VLaHHS. The performance was assessed based on the following metrics with possible scores in parenthesis: * Created Equidistant Sutures (0,3,5) * Smooth Tool Handling (0,3,5) * Respect for Tissue (0, 3, 5) * Created All Full Thickness Bites (0, 3, 5) * Performed Correct In-Out Sequence of suturing (0, 3, 5) * Did Not Collided with Esophagus (0, 3, 5) * Created Correct Amount of Knots (0, 3, 5) * Tightened All Knots (0,3,5) * Correctly Performed Slipknots (0, 3, 5). The final numerical score is the sum of all individual performance measures which can range from a minimum of 0 to a maximum of 45. Higher score denotes better performance.
Skill Level in Participants Assessed by NASA-TLX Questionnaire
Time frame: Baseline (at pre-test)
Dependent measures for learning curve will be measured using the NASA-TLX questionnaire. The NASA Task Load Index (NASA-TLX) is a tool to subjectively assess cognitive and emotional load during a simulation. Students rate six dimensions: mental and physical demands, time pressure, performance, effort, and frustration. Each dimension is assessed on a scale of 0-10, with a possible total score range of 0 to 60. A higher value indicates a higher burden.
Skill Level in Participants as Assessed by Completion Time
Time frame: Immediately post test (three weeks after pre-test)
Dependent measures for learning curve will be assessed by completion time of the participants on the VLAHHS Crural Repair task.
Skill Level in Participants Assessed by Numerical Performance Score on the VLaHHS
Time frame: Immediately post test (three weeks after pre-test)
Dependent measures for learning curve will be assessed by numerical score computed based on performance on the VLaHHS. The performance was assessed based on the following metrics with possible scores in parenthesis, * Created Equidistant Sutures (0,3,5) * Smooth Tool Handling (0,3,5) * Respect for Tissue (0, 3, 5) * Created All Full Thickness Bites (0, 3, 5) * Performed Correct In-Out Sequence of suturing (0, 3, 5) * Did Not Collided with Esophagus (0, 3, 5) * Created Correct Amount of Knots (0, 3, 5) * Tightened All Knots (0,3,5) * Correctly Performed Slipknots (0, 3, 5). The final numerical score is the sum of all individual performance measures which can range from a minimum of 0 to a maximum of 45. Higher score denotes better performance.
Skill Level in Participants Assessed by NASA-TLX Questionnaire
Time frame: Immediately post test (three weeks after pre-test)
Dependent measures for learning curve will be measured using the NASA-TLX questionnaire. The NASA Task Load Index (NASA-TLX) is a tool to subjectively assess cognitive and emotional load during a simulation. Students rate six dimensions: mental and physical demands, time pressure, performance, effort, and frustration. Each dimension is assessed on a scale of 0-10, with a possible total score range of 0 to 60. A higher value indicates a higher burden.
Skill Retention in Participants as Assessed by Completion Time
Time frame: 2 weeks after post test
Dependent measures will be assessed by completion time of participants on the VLAHHS Crural repair task.
Skill Level in Participants Assessed by Numerical Performance Scale on the VLaHHS
Time frame: 2 weeks after post test
Dependent measures for learning curve will be assessed by numerical score computed based on performance on the VLaHHS. The performance was assessed based on the following metrics with possible scores in parenthesis, * Created Equidistant Sutures (0,3,5) * Smooth Tool Handling (0,3,5) * Respect for Tissue (0, 3, 5) * Created All Full Thickness Bites (0, 3, 5) * Performed Correct In-Out Sequence of suturing (0, 3, 5) * Did Not Collided with Esophagus (0, 3, 5) * Created Correct Amount of Knots (0, 3, 5) * Tightened All Knots (0,3,5) * Correctly Performed Slipknots (0, 3, 5). The final numerical score is the sum of all individual performance measures which can range from a minimum of 0 to a maximum of 45. Higher score denotes better performance.
Skill Retention in Participants as Assessed by NASA-TLX Questionnaire
Time frame: 2 weeks after post test
Dependent measures for learning curve will be measured using the NASA-TLX questionnaire. The NASA Task Load Index (NASA-TLX) is a tool to subjectively assess cognitive and emotional load during a simulation. Students rate six dimensions: mental and physical demands, time pressure, performance, effort, and frustration. Each dimension is assessed on a scale of 0-10, with a possible total score range of 0 to 60. A higher value indicates a higher burden.
Transfer of Skill in Participants as Assessed by Performance Score
Time frame: Immediately post test (three weeks after pre-test)
This measure will be assessed using a performance score assessed using a modified tool that consists of Global Assessment Tools for Intraoperative Laparoscopic Skills (GOALS) domains and task-specific metrics. The individual assessment items and their possible scores are: 1. Depth perception (0,3,5) 2. Bimanual dexterity (0,3,5) 3. Efficiency (0,3,5) 4. Tissue handling (0,3,5) 5. Knowledge of procedure (0,3,5) 6. Flow of operation (0,3,5) 7. Instrument handling (0,3,5) 8. Bite size (0,3,5) 9. Knot tying (0,3,5) 10. Needle handling (0,3,5) 11. Crural repair closure (0,3,5) 12. Tissue bites (0,3,5) The total range for the transfer of skills score will be 0-60 with higher score indicating better performance.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Ganesh Sankaranarayanan, Ph.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training with Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS) in people with Predictive Validity of VLaHHS, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 19 May 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 19 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Skill Level in Participants as Assessed by Completion Time (time frame: Baseline (at pre-test)). The study lists 10 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 19 May 2026.