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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04843436
- Acronym / sponsor ID
- PRIMO / CDC-00031
- Keywords
- microsurgery, RASM, free flap, lymphatic ducts, Symani
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- MMI (Medical Microinstruments, Inc.)Industry (pharma, biotech, devices)
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Posted 9 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Assisted Microsurgery | Experimental | Device: Symani Surgical SystemPatients who meet the eligibility criteria for the study and undergo a microsurgical reconstruction using the Symani System according to its indications for use. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symani Surgical SystemRobotically Assisted Microsurgery | Device | Robotic Assisted Microsurgery |
Primary outcome
Procedure Robotic Success
Time frame: Duration of the robotic anastomotic portion of the participants index procedure
Ability to complete the surgical task with Symani as intended by the surgeon
7 secondary outcomes
Anastomosis Time
Time frame: Procedure
Intraoperative Redo
Time frame: Procedure
Percentage of Participants With Postoperative Redo Within 7 Days
Time frame: 7 days
Surgeon Assessment of Robotic Usability
Time frame: 30 days
Free Flap Survival at Discharge
Time frame: discharge
Limb Volume Reduction (for Lymphatic Surgery)
Time frame: 24 weeks
Warm Ischemia Time
Time frame: Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Innocenti, Prof. principal investigator
Istituto Ortopedico Rizzoli Bologna
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Italy, Austria, Belgium, Finland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure Robotic Success (time frame: Duration of the robotic anastomotic portion of the participants index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.