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CompletedNCT05191589Updated Jan 13, 2022

Haptic Devices Impact on Laparoscopic Simulators

An interventional study of Haptic in Medical Education, sponsored by Copenhagen Academy for Medical Education and Simulation. Completed at 2 sites in Denmark. Per ClinicalTrials.gov, last updated 2022-01-13.

Sponsored by Copenhagen Academy for Medical Education and Simulation · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Oct 2020, registered Feb 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Medical Education
03

In context

Lead sponsor

Copenhagen Academy for Medical Education and Simulation is the lead sponsor of 27 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Must be a junior doctor working in a surgical department

Exclusion criteria

Exclusion Criteria:

  • Having performed any laparoscopic surgeries as primary surgeon
  • Lack of Basic Danish on a conversational basis
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Intervention Group

    In the intervention group trainees will train in an already validated laparoscopic training program with haptic devices.

    Other: Haptic

  • No intervention
    Control

    In the control group trainees will complete the same validated training program in the conventional non-haptic setting.

Interventions

  • OtherHaptic

    Trainees are randomized in this group to use the haptic device.

06

What researchers measure

Primary outcomes

  1. Time (minutes) to reach the predefined proficiency level for the basic skills and salpingectomy procedure

    Measured in minutes

    Time frame: 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

    Time frame: From randomization till participants passes all modules on the virtual reality simulator in the trial (approx. 3-4 weeks)

Other outcomes

  1. Exploratory outcome: To observe and register mechanical/technical malfunctions during the intervention and retention.

    All mechanical malfunction will be registered and classified afterwards

    Time frame: During trial, up to 1 year

07

Study locations

2 sites
  • CAMES
    Copenhagen, Region Hovedstaden 2100, Denmark
  • CAMES
    Copenhagen, 2100, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05191589
Lead sponsor
Copenhagen Academy for Medical Education and Simulation
Responsible party
Anishan Vamadevan (Medical Student and Research Fellow, Copenhagen Academy for Medical Education and Simulation) — Principal investigator
First posted
Jan 13, 2022
Start date
Oct 1, 2020
Primary completion
Jan 15, 2021
Completion
Feb 1, 2021
Last update
Jan 13, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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