Performance of Robotic Microsurgery Systems

NCT06146023 | Completed FDA Device

• 1 other identifier: 2000034951
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Learning curve; Robotics; Surgical ergonomics; Surgical training

Outcome Measures

Primary Outcomes (3)

• Surgical time

  Time to perform anastomosis in minutes and seconds.

  Duration of anastomosis

• Anastomosis quality

  Anastomosis lapse index (ALI) to evaluate the quality of each stitch. Score indicates absolute number of errors per anastomosis. Low values indicate better results.

  Evaluated right after completion of each anastomosis

• Microsurgical skills

  Structured assessment of microsurgery skills (SAMS) to evaluate microsurgical skill acquisition. Score includes 8 items evaluated from 1 (minimum) to 5 (maximum). High values indicate better results.

  Duration of anastomosis

Secondary Outcomes (2)

• Subjective Satisfaction

  Evaluated right after completion of each anastomosis

• Surgical ergonomics

  Evaluated right after completion of each anastomosis

Study Arms (2)

Conventional

ACTIVE COMPARATOR

Conventional microsurgery with conventional microsurgical instruments and conventional surgical microscope

Procedure: Conventional anastomosis

Robotic

EXPERIMENTAL

Robot-assisted microsurgery with microsurgery robot and robotic microscope

Device: Robotic anastomosis (Symani surgical system and RoboticScope)

Interventions

Robotic anastomosis (Symani surgical system and RoboticScope) DEVICE

Robot-assisted microvascular anastomosis on 1.0-mm-diameter silicone vessels using the Symani surgical system and RoboticScope

Robotic

Conventional anastomosis PROCEDURE

Conventional microvascular anastomosis on 1.0-mm-diameter silicone vessels using conventional microsurgical instruments and conventional surgical microscope

Conventional

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Novices: no prior experience in microsurgery
• Residents: 2-4 years of experience in microsurgery
• Experts: at least 5 years of experience in microsurgery

You may not qualify if:

• previous training with the robotic devices applied in this study
• contraindications for usage of robotic devices (magnetic field)

Sponsors & Collaborators

• University Hospital Muenster: lead
• Yale University: collaborator

Study Sites (2)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

University Hospital Muenster

Münster, 48149, Germany

Location

Study Officials

• Maximilian Kückelhaus, MD

  University Hospital Muenster

  PRINCIPAL INVESTIGATOR

• Haripriya S Ayyala, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded for participant groups and number of anastomosis during evaluation of scores.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Comparison of conventional manual microsurgery versus robot-assisted microsurgery

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 24, 2023
• Study Start: October 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); US (1)