A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons

Part of paid clinical trials in Beverly Hills, California.

Sponsor
MMI (Medical Microinstruments, Inc.)
Study ID
NCT06725030
Status
Recruiting
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Conditions

  • Anastomosis, Surgical
  • Free Tissue Transfer
  • Lymphedema
  • Microsurgery
  • Open Surgery

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Symani Surgical System — DEVICE
    The Symani Surgical System (Symani) is designed for open microsurgery procedures, featuring articulated and interchangeable instruments.

Study Details

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.

Key Dates

Start date
Sep 22, 2025
Status verified
Mar 2026
Primary completion
Sep 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
455 participants (estimated)

Arms

  • Arm: Free Tissue Transfer Surgery
  • Arm: Lymphovenous Anastomosis Surgery

Primary Outcome Measure

Freedom from device-related adverse events from the start of the index procedure through 30-days post index procedure as adjudicated by a Clinical Events Committee [ Time Frame: From participants index procedure through 30-days post index procedure. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterBeverly HillsCalifornia90048
Laura Sarmiento
[email protected]
Curtis Cetrulo (PRINCIPAL_INVESTIGATOR)
Yale New Haven HospitalNew HavenConnecticut06511
Siba Haykal (PRINCIPAL_INVESTIGATOR)
Tampa General HospitalTampaFlorida33606
Chloe Grabowski
[email protected]
Nicholas Panetta (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Beverly Doyle
[email protected]
Graham Schwarz (PRINCIPAL_INVESTIGATOR)

Find similar trials in Beverly Hills, CA

By research site
Cedars Sinai Medical Center· Beverly Hills, CAYale New Haven Hospital· New Haven, CTTampa General Hospital· Tampa, FLCleveland Clinic· Cleveland, OH

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