NCT04843436

Brief Summary

Post Market Clinical Follow up Study aimed to collect clinical data on safety and efficacy of Robotically Assisted System called Symani to perform microsurgery techniques such as anastomosis, suturing and ligation for open surgery procedures on small anatomical structures such as blood vessels, lymphatic ducts and nerves.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
427

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
7 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 13, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2025

Completed
Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

3.8 years

First QC Date

April 8, 2021

Last Update Submit

December 30, 2025

Conditions

Free FlapsOpen SurgeryBlood Vessels, Lymphatic Ducts and Nerves

Keywords

microsurgeryRASMfree flaplymphatic ductsSymani

Outcome Measures

Primary Outcomes (1)

  • Procedure Robotic Success

    Ability to complete the surgical task with Symani as intended by the surgeon

    Procedure

Secondary Outcomes (7)

  • Anastomosis time

    Procedure

  • Intraoperative redo

    Procedure

  • Postoperative redo

    7 days

  • Complications

    30 days

  • Free Flap/Replantation Failure

    30 days

  • +2 more secondary outcomes

Study Arms (1)

Robotic Assisted Microsurgery

EXPERIMENTAL

Patients who meet the eligibility criteria for the study and undergo a microsurgical reconstruction using the Symani System according to its indications for use.

Device: Symani Surgical System

Interventions

Symani Surgical SystemDEVICE

Robotically Assisted Microsurgery

Robotic Assisted Microsurgery

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients aged \>18
  • Patients who need a reconstructive procedure and a microsurgical reconstruction is deemed the best option by the plastic, orthopedic or other surgeon in response to a post-oncological, post-traumatic or congenital tissue defect or to treat lymphedema.
  • Patients who have been selected by the PI at the Clinical Center as appropriate candidates for treatment with Symani System in accordance with the IFU.
  • Subjects who fit the criteria to perform surgery requiring reconstructions using free flaps, replantation, lymphatic reconstructions.
  • Subjects who agree to have the surgery and the anaesthesia.
  • Subjects who voluntarily decide to participate in this study with the surgery performed with the aid of the Symani System and sign the Informed Consent Form.

You may not qualify if:

  • Subjects who have bleeding or coagulation disorders in the past or present.
  • Any criteria that preclude prolonged anesthesia.
  • History of anaphylaxis or severe complicated allergy symptoms.
  • Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders or previous mental disorders that may significantly affect the data collection or the ability to comply with the protocol.
  • Evidence or history of autoimmune disease or compromised immune system.
  • Participation in another clinical trial within 4 weeks prior to participation in the study.
  • Subjects belonging to vulnerable populations or ineligible to participate for other reasons by the PI at a Clinical Center.
  • Subjects with pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

LKH Salzburg, Universitätsklinik für Mund-, Kiefer- und Gesichtschirurgie

Salzburg, 5020, Austria

Location

Universitair Ziekenhuis Brussel

Brussels, Belgium

Location

Helsinki University Hospital

Helsinki, 00029, Finland

Location

Klinik für Mund-, Kiefer- und Gesichtschirurgie UKSH Kiel

Kiel, 24105, Germany

Location

BG Kliniken Ludwigshafen

Ludwigshafen, 67071, Germany

Location

Fachklinik Hornheide

Münster, 48157, Germany

Location

Istituto Ortopedico Rizzoli

Bologna, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Study Officials

  • Marco Innocenti, Prof.

    Istituto Ortopedico Rizzoli Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 13, 2021

Study Start

April 13, 2021

Primary Completion

February 6, 2025

Study Completion

July 18, 2025

Last Updated

January 5, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)FI(1)ES(1)CH(1)IT(2)BE(1)AU(1)