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

NCT06725030 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 455

Last updated 2026-03-05

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

Symani Surgical System

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

Sponsors & Collaborators

  • MMI (Medical Microinstruments, Inc.)

    lead INDUSTRY

Principal Investigators

  • Bohdan Pomahac, MD · Yale New Haven Medical Center

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-22
Primary Completion
2027-09-01
Completion
2027-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06725030 on ClinicalTrials.gov