Symani Surgical System for Microsurgery

(PRECISE Trial)

Recruiting at 1 trial location

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?

This trial tests a new robotic system, the Symani Surgical System, to evaluate its safety and effectiveness for very fine surgery on tiny blood vessels. It focuses on two types of surgeries: free tissue transfer, which involves moving tissue to new places in the body, and treating lymphedema, or swelling due to fluid build-up, in arms or legs. Potential participants include those needing surgery to connect small blood vessels in the breast or limbs, or those with arm or leg swelling not improved by basic treatments like elevation or compression. Participants must follow the study plan, which includes attending follow-up visits and completing questionnaires. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the validation of a potentially groundbreaking surgical technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the Symani Surgical System is safe for microsurgery?

Research has shown that the Symani Surgical System is generally safe for very small, precise surgeries. One study found no unusual issues at the surgery site or elsewhere in the body, supporting the system's safety. Another study confirmed its safety and effectiveness for delicate surgeries, such as tissue transfer and lymphatic reconstruction.

These studies indicate that the Symani System is well-tolerated in surgical settings, with a low risk of complications. Participants can feel confident knowing the system has been tested and proven safe for various types of microsurgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Symani Surgical System is unique because it offers enhanced precision and control in microsurgery through its advanced robotic capabilities. Unlike traditional surgical techniques, which rely heavily on the surgeon's steady hand, the Symani system uses robotic arms to perform delicate operations, potentially reducing human error and improving outcomes. Researchers are excited about this system because it could lead to more successful surgeries in complex procedures like Free Tissue Transfer and Lymphovenous Anastomosis, where precision is critical. Additionally, the robotic assistance might shorten recovery times and reduce complications, making it a promising advancement in surgical technology.

What evidence suggests that the Symani Surgical System is effective for microsurgical anastomosis?

Research has shown that the Symani Surgical System performs well in very precise surgeries, particularly when connecting tiny blood or lymphatic vessels. In this trial, participants will undergo either Free Tissue Transfer Surgery or Lymphovenous Anastomosis Surgery using the Symani Surgical System. Studies have found that it successfully maintains over 90% of these connections on the first attempt. This indicates the system's reliability for complex surgeries. Additionally, real-world use has demonstrated its safety and effectiveness in various precise surgical procedures. This consistent performance makes it a promising choice for delicate surgical repairs. ^{1 2 4 6 7}

Who Is on the Research Team?

Bohdan Pomahac, MD

Principal Investigator

Yale New Haven Medical Center

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06725030

Study Details | NCT06725030 | A Post-market, Real-world ... The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10998780/

a two-year single-center experience with robotic-assisted ... Our study gives an insight into the details and outcomes of the first 100 consecutive (super-) microsurgical anastomoses in peripheral and central lymphatic ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06628219

Study Details | NCT06628219 | A Global, Prospective, Real ... The objective of this clinical study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer ...

4. journals.lww.com journals.lww.com/prsgo/fulltext/2025/07000/feasibility_and_current_applications_of_the_symani.28.aspx

Feasibility and Current Applications of the Symani Surgical ... High rates of intraoperative anastomosis patency (>90%) have been demonstrated, but remain to be evaluated in head-to-head comparisons with ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN230032.pdf

DEN230032, Symani Surgical System, MMI North America, Inc. The Symani study provides evidence of the safety and effectiveness of the Symani Surgical System when used to assisted microsurgical anastomosis ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681524003450

Safety and efficacy of Symani robotic-assisted microsurgery The absence of abnormalities at the anastomosis site and in non-target organs confirms the overall safety profile of the robotic platform. Our study validates ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9593278/

Exploring the learning curve of a new robotic microsurgical ... We have recently shown the feasibility and safety in performing micro- and supermicrosurgical anastomosis in lymphatic reconstruction with the ...