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Robot-Assisted microsurgery shows promise in Real-World study

NCT ID NCT04843436

Disease control Sponsor: MMI (Medical Microinstruments, Inc.) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well a robotic system called Symani helps surgeons perform very precise reconstructive surgeries on small blood vessels, lymph vessels, and nerves. It included 427 adults who needed this type of surgery after cancer, injury, birth defects, or for lymphedema. The main goal was to see if the robot could complete the surgical tasks as intended.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

427 people

The number who actually took part.

Started

Apr 2021

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

lymphedema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blood vessels, lymphatic ducts and nerves Free flaps Open surgery

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Italy

  • BG Kliniken Ludwigshafen

    Ludwigshafen, 67071, Germany

  • Fachklinik Hornheide

    Münster, 48157, Germany

  • Helsinki University Hospital

    Helsinki, 00029, Finland

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • Istituto Ortopedico Rizzoli

    Bologna, Italy

  • Klinik für Mund-, Kiefer- und Gesichtschirurgie UKSH Kiel

    Kiel, 24105, Germany

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

    Salzburg, 5020, Austria

  • Universitair Ziekenhuis Brussel

    Brussels, Belgium

  • University Hospital Zurich

    Zurich, 8091, Switzerland

More trials for these conditions

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