MedTrace Logo

A Global, Prospective, Real-World, Investigation of the Symani® Surgical System for Microsurgical Anastomosis

NCT06628219 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2024-12-10

No results posted yet for this study

Summary

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

The primary endpoints are:

* Effectiveness: Clinical Success, defined as intraoperative anastomosis patency.
* Safety: Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee.

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 therapeutic lymphatic procedure, they will be asked to complete a questionnaire and undergo lymphedema volume assessments as part of the study. If participants are undergoing a prophylactic lymphatic procedure, they will only be asked to undergo limb volume assessments.
* Participants will be asked to comply with the follow-up visits as outlined in the protocol.

Conditions

  • Open Surgery
  • Lymphedema
  • Free Tissue Transfer
  • Microsurgery

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

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2026-02-01
Completion
2030-02-01
FDA Device
Yes

More Related Trials

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 NCT06628219 on ClinicalTrials.gov