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PRIMO Post-Market Clinical Follow Up Study

NCT04843436 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 427

Last updated 2026-01-05

No results posted yet for this study

Summary

Post Market Clinical Follow up Study aimed to collect clinical data on safety and efficacy of Robotically Assisted System called Symani to perform microsurgery techniques such as anastomosis, suturing and ligation for open surgery procedures on small anatomical structures such as blood vessels, lymphatic ducts and nerves.

Conditions

  • Open Surgery
  • Blood Vessels, Lymphatic Ducts and Nerves
  • Free Flaps

Interventions

DEVICE

Symani Surgical System

Robotically Assisted Microsurgery

Sponsors & Collaborators

  • MMI (Medical Microinstruments, Inc.)

    lead INDUSTRY

Principal Investigators

  • Marco Innocenti, Prof. · Istituto Ortopedico Rizzoli Bologna

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-13
Primary Completion
2025-02-06
Completion
2025-07-18

Countries

  • Austria
  • Belgium
  • Finland
  • Germany
  • Italy
  • Spain
  • Switzerland

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 NCT04843436 on ClinicalTrials.gov