Open SurgeryPRIMONCT04843436
PRIMO Post-Market Clinical Follow Up Study
A study testing Symani Surgical System in people with Open Surgery and Blood Vessels, Lymphatic Ducts and Nerves, run by MMI (Medical Microinstruments, Inc.) at 10 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Open Surgery, Blood Vessels, Lymphatic Ducts and Nerves, Free Flaps
- What is being tested?
- Symani Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 427 participants
- Where
- 10 sitesin 7 countries
- Study dates
- 13 Apr 2021to 18 Jul 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
Germany3 sites
Klinik für Mund-, Kiefer- und Gesichtschirurgie UKSH Kiel
Kiel, 24105
BG Kliniken Ludwigshafen
Ludwigshafen, 67071
Fachklinik Hornheide
Münster, 48157
Italy2 sites
Istituto Ortopedico Rizzoli
Bologna
Azienda Ospedaliera Universitaria Careggi
Florence
Austria1 site
LKH Salzburg, Universitätsklinik für Mund-, Kiefer- und Gesichtschirurgie
Salzburg, 5020
About this study
Official title: Post-Market, Non-Randomized, Multicentre PMCF Study to Monitor the Safety and Performance of Symani System in Microsurgical Reconstructive Procedures in a Real Life Setting
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.
Read the detailed description
PMCF study aimed to monitor the safety, usability, performance and long-term efficacy of Symani. Furthermore, it will permit to detect potential emerging risks related to safety on the basis of clinical evidence through the observation of patients who have undergone microsurgical reconstructions using the Symani Surgical System in the usual setting of standard surgical practice.
- Being tested
- Symani Surgical System
- Keywords
- microsurgery, RASM, free flap, lymphatic ducts, Symani
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symani Surgical SystemDevice
Robotically Assisted Microsurgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Symani Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Robotic Success
Ability to complete the surgical task with Symani as intended by the surgeon
Measured: Duration of the robotic anastomotic portion of the participants index procedure
Secondary outcomes (7)
Anastomosis Time
Time to execute each fully robotic anastomosis.
*Please note - three participants underwent a Free Flap and LVA surgery and therefore are accounted for in each cohort.
Measured: Procedure
Intraoperative Redo
Intraoperative need to repeat anastomosis
Measured: Procedure
Percentage of Participants With Postoperative Redo Within 7 Days
Post-operative redos were identified as the need to return to the operating room to explore anastomosis.
Measured: 7 days
Surgeon Assessment of Robotic Usability
Surgeons were asked to complete a questionnaire for each patient operated on using the study device.
Success was defined as a response of complete or partial procedure success.
Measured: 30 days
Free Flap Survival at Discharge
This effectiveness endpoint is assessed only for free flap procedures undertaken in the FAS. Subjects were assessed at the time of discharge for free flap survival status.For patients with free flap procedures, the average hospital stay was 11.9 days.
Measured: discharge
Limb Volume Reduction (for Lymphatic Surgery)
Limb volume reduction
Measured: 24 weeks
Warm Ischemia Time
Time for warm ischemia
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start13 Apr 2021
- Primary completion6 Feb 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Open SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- MMI (Medical Microinstruments, Inc.)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marco Innocenti, Prof., Principal investigator, Istituto Ortopedico Rizzoli Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843436
- Sponsor's protocol ID
- CDC-00031
- Acronym
- PRIMO
- Status last verified
- Jun 2026
- First submitted
- 8 Apr 2021
- Last updated
- 9 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No