Symani Surgical System for Microsurgery

(PRECISE Trial)

Overseen By Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MMI Spa

Disqualifiers: Infection, Cardiovascular disorders, Chemotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of the index procedure

455 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery.

The primary endpoints are:

* Effectiveness- Rate of intraoperative anastomosis patency at first attempt.

* Safety- Freedom from device-related adverse events.

Participants will receive treatment as standard of care and be asked to:

* Allow the researchers to access and use their information.

* If participants are undergoing a lymphedema procedure, they will be asked to undergo a questionnaire as part of the study.

* Participants will be asked to comply with the follow-up visits and complete all study procedures/questionnaires as outlined in the protocol.

Are You a Good Fit for This Trial?

This trial is for adults over 22 needing microsurgical anastomosis during free tissue transfer or lymphovenous anastomosis surgery. Candidates must consent to study requirements and follow-ups, with suitable conditions for robotic-assisted procedures using the Symani System.

Inclusion Criteria

I am at least 22 years old.

I need surgery involving tiny blood vessels for breast or limb reconstruction.

My doctor approves me for specific reconstructive surgeries using the Symani System.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo microsurgical anastomosis using the Symani System during free tissue transfer or lymphovenous anastomosis surgery

Duration of the index procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including freedom from device-related adverse events

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Symani Surgical System

Trial Overview The Symani Surgical System's safety and effectiveness are being tested in surgeries involving tiny blood vessels. The focus is on successful vessel connection on the first try (effectiveness) and avoiding device-related complications (safety).

How Is the Trial Designed?

Group I: Lymphovenous Anastomosis Surgery Experimental Treatment 1 Intervention

Group II: Free Tissue Transfer Surgery Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

MMI Spa

Lead Sponsor

Trials

4

Recruited

2,000+

MMI (Medical Microinstruments, Inc.)

Lead Sponsor