Trials / Completed
CompletedNCT06146023
Performance of Robotic Microsurgery Systems
Preclinical Performance of The Combined Application of Two Robotic Systems in Microsurgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- University Hospital Muenster · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
Summary
The goal of this preclinical trial is to learn about the benefits and limitations of novel robotic devices for microsurgery, based on different levels of microsurgical experience. The main questions it aims to answer are: Is robot-assisted microsurgery faster, better and more ergonomic than conventional microsurgery in a preclinical standardized setting? Participants will perform microvascular anastomoses on 1.0-mm-diameter artificial silicone vessels using a conventional manual approach versus a novel robot-assisted approach. Researchers will compare the performance of novices, advanced participants and experts to evaluate the role of microsurgical experience when learning the new technique.
Detailed description
Recent advancements in the development of robotic devices increasingly draw the attention towards the concept of robotic microsurgery, as several systems tailored to open microsurgery are being introduced. This study describes the combined application of a novel microsurgical robot, the Symani, with a novel robotic microscope, the RoboticScope, for the performance of microvascular anastomoses in a two-center preclinical trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Robotic anastomosis (Symani surgical system and RoboticScope) | Robot-assisted microvascular anastomosis on 1.0-mm-diameter silicone vessels using the Symani surgical system and RoboticScope |
| PROCEDURE | Conventional anastomosis | Conventional microvascular anastomosis on 1.0-mm-diameter silicone vessels using conventional microsurgical instruments and conventional surgical microscope |
Timeline
- Start date
- 2022-10-01
- Primary completion
- 2023-07-01
- Completion
- 2023-07-01
- First posted
- 2023-11-24
- Last updated
- 2023-11-24
Locations
2 sites across 2 countries: United States, Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06146023. Inclusion in this directory is not an endorsement.