Medical EducationNCT05191589
Haptic Devices Impact on Laparoscopic Simulators
A study testing Haptic in people with Medical Education, run by Copenhagen Academy for Medical Education and Simulation at 2 sites in Denmark.
Trial summary
The study investigates the impact haptic devices have on reaching proficiency on a laparoscopic simulator as well as investigation if there is a difference in retention of the acquired skills. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Medical Education
- What is being tested?
- Haptic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Oct 2020to 1 Feb 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Must be a junior doctor working in a surgical department
Who cannot join
- Having performed any laparoscopic surgeries as primary surgeon
- Lack of Basic Danish on a conversational basis
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Haptic Devices vs Non Haptic Devices - Results of a Randomized Trial
The study investigates the impact haptic devices have on reaching proficiency on a laparoscopic simulator as well as investigation if there is a difference in retention of the acquired skills.
- Conditions
- Medical Education
- Being tested
- Haptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HapticOther
Trainees are randomized in this group to use the haptic device.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | In the intervention group trainees will train in an already validated laparoscopic training program with haptic devices. Receives: Other: Haptic |
| Control | No intervention | In the control group trainees will complete the same validated training program in the conventional non-haptic setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (minutes) to reach the predefined proficiency level for the basic skills and salpingectomy procedure
Measured in minutes
Measured: From randomization till participants have passed all modules on the simulator (approx 3-4 weeks)
Secondary outcomes (1)
Time (minutes) to reach the predefined proficiency level for the basic skills and salpingectomy procedure after 3-6 weeks without laparoscopic training on the non-haptic devices (retention test).
Measured in minutes
Measured: From randomization till participants passes all modules on the virtual reality simulator in the trial (approx. 3-4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Oct 2020
- Primary completion15 Jan 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EducationStudies 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
- Trainees/participants are randomized to either control or interventional group. After reaching proficiency participants must come back after 3-6 weeks to perform a retention test.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen Academy for Medical Education and Simulation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anishan Vamadevan, Copenhagen Academy for Medical Education and Simulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191589
- Sponsor's protocol ID
- CAMES
- Status last verified
- Jan 2022
- First submitted
- 11 Feb 2021
- Last updated
- 13 Jan 2022
- Results posted
- 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 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haptic Devices vs Non Haptic Devices - Results of a Randomized Trial
- ClinicalTrials.gov ID
- NCT05191589
- Acronym / sponsor ID
- CAMES
- Conditions
- Medical Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Copenhagen Academy for Medical Education and SimulationUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 13 Jan 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.
The study investigates the impact haptic devices have on reaching proficiency on a laparoscopic simulator as well as investigation if there is a difference in retention of the acquired skills.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Trainees/participants are randomized to either control or interventional group. After reaching proficiency participants must come back after 3-6 weeks to perform a retention test.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: HapticIn the intervention group trainees will train in an already validated laparoscopic training program with haptic devices. |
| Control | No intervention | –In the control group trainees will complete the same validated training program in the conventional non-haptic setting. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Must be a junior doctor working in a surgical department
Key exclusion criteria (2 listed)
- Having performed any laparoscopic surgeries as primary surgeon
- Lack of Basic Danish on a conversational basis
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 |
|---|---|---|
| HapticTrainees are randomized in this group to use the haptic device. | Other | Intervention Group |
Primary outcome
Time (minutes) to reach the predefined proficiency level for the basic skills and salpingectomy procedure
Time frame: From randomization till participants have passed all modules on the simulator (approx 3-4 weeks)
Measured in minutes
1 secondary outcome
Time (minutes) to reach the predefined proficiency level for the basic skills and salpingectomy procedure after 3-6 weeks without laparoscopic training on the non-haptic devices (retention test).
Time frame: From randomization till participants passes all modules on the virtual reality simulator in the trial (approx. 3-4 weeks)
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 13 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haptic in people with Medical Education, run by Copenhagen Academy for Medical Education and Simulation at 2 sites in Denmark.
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 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Time (minutes) to reach the predefined proficiency level for the basic skills and salpingectomy procedure (time frame: From randomization till participants have passed all modules on the simulator (approx 3-4 weeks)). 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 13 Jan 2022.