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Performance of Robotic Microsurgery Systems

NCT06146023 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-11-24

No results posted yet for this study

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.

Conditions

  • Robotic Surgery
  • Microsurgery
  • Anastomosis

Interventions

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

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • University Hospital Muenster

    lead OTHER

Principal Investigators

  • Maximilian Kückelhaus, MD · University Hospital Muenster

  • Haripriya S Ayyala, MD · Yale University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-07-01
Completion
2023-07-01
FDA Device
Yes

Countries

  • United States
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06146023 on ClinicalTrials.gov