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Performance of Robotic Microsurgery Systems

NCT ID: NCT06146023

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-07-01

Brief Summary

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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

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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

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Robotic Surgery Microsurgery Anastomosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Comparison of conventional manual microsurgery versus robot-assisted microsurgery
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessors are blinded for participant groups and number of anastomosis during evaluation of scores.

Study Groups

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Conventional

Conventional microsurgery with conventional microsurgical instruments and conventional surgical microscope

Group Type ACTIVE_COMPARATOR

Conventional anastomosis

Intervention Type PROCEDURE

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

Robotic

Robot-assisted microsurgery with microsurgery robot and robotic microscope

Group Type EXPERIMENTAL

Robotic anastomosis (Symani surgical system and RoboticScope)

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Conventional anastomosis

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role collaborator

University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Kai Wessel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maximilian Kückelhaus, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Muenster

Haripriya S Ayyala, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status

University Hospital Muenster

Münster, , Germany

Site Status

Countries

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United States Germany

Other Identifiers

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2000034951

Identifier Type: -

Identifier Source: org_study_id