PRIMO Post-Market Clinical Follow Up Study

NCT04843436 | Completed Results

• 1 other identifier: CDC-00031
• Study Type: interventional
• Target: 427
• Locations: 7 countries
• Sites: 10

Brief 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

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

Keywords

microsurgery; RASM; free flap; lymphatic ducts; Symani

Outcome Measures

Primary Outcomes (1)

• Procedure Robotic Success

  Ability to complete the surgical task with Symani as intended by the surgeon

  Duration of the robotic anastomotic portion of the participants index procedure

Secondary Outcomes (7)

• Anastomosis Time

  Procedure

• Intraoperative Redo

  Procedure

• Percentage of Participants With Postoperative Redo Within 7 Days

  7 days

• Surgeon Assessment of Robotic Usability

  30 days

• Free Flap Survival at Discharge

  discharge

Study Arms (1)

Robotic Assisted Microsurgery

EXPERIMENTAL

Patients who meet the eligibility criteria for the study and undergo a microsurgical reconstruction using the Symani System according to its indications for use.

Device: Symani Surgical System

Interventions

Symani Surgical System DEVICE

Robotically Assisted Microsurgery

Robotic Assisted Microsurgery

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged \>18
• Patients who need a reconstructive procedure and a microsurgical reconstruction is deemed the best option by the plastic, orthopedic or other surgeon in response to a post-oncological, post-traumatic or congenital tissue defect or to treat lymphedema.
• Patients who have been selected by the PI at the Clinical Center as appropriate candidates for treatment with Symani System in accordance with the IFU.
• Subjects who fit the criteria to perform surgery requiring reconstructions using free flaps, replantation, lymphatic reconstructions.
• Subjects who agree to have the surgery and the anaesthesia.
• Subjects who voluntarily decide to participate in this study with the surgery performed with the aid of the Symani System and sign the Informed Consent Form.

You may not qualify if:

• Subjects who have bleeding or coagulation disorders in the past or present.
• Any criteria that preclude prolonged anesthesia.
• History of anaphylaxis or severe complicated allergy symptoms.
• Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders or previous mental disorders that may significantly affect the data collection or the ability to comply with the protocol.
• Evidence or history of autoimmune disease or compromised immune system.
• Participation in another clinical trial within 4 weeks prior to participation in the study.
• Subjects belonging to vulnerable populations or ineligible to participate for other reasons by the PI at a Clinical Center.
• Subjects with pacemaker

Sponsors & Collaborators

• MMI (Medical Microinstruments, Inc.): lead

Study Sites (10)

LKH Salzburg, Universitätsklinik für Mund-, Kiefer- und Gesichtschirurgie

Salzburg, 5020, Austria

Location

Universitair Ziekenhuis Brussel

Brussels, Belgium

Location

Helsinki University Hospital

Helsinki, 00029, Finland

Location

Klinik für Mund-, Kiefer- und Gesichtschirurgie UKSH Kiel

Kiel, 24105, Germany

Location

BG Kliniken Ludwigshafen

Ludwigshafen, 67071, Germany

Location

Fachklinik Hornheide

Münster, 48157, Germany

Location

Istituto Ortopedico Rizzoli

Bologna, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Results Point of Contact

• Title: Clinical Operations
• Organization: Medical Microinstruments

clinical.ops@mmimicro.com

8336646276

Study Officials

• Marco Innocenti, Prof.

  Istituto Ortopedico Rizzoli Bologna

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: April 13, 2021
• Primary Completion: February 6, 2025
• Study Completion: July 18, 2025
• Last Updated: June 9, 2026
• Results First Posted: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1); ES (1); CH (1); BE (1); AU (1); DE (3); IT (2)