Clinical trial NCT04843436: PRIMO Post-Market Clinical Follow Up Study
Official title: Post-Market, Non-Randomized, Multicentre PMCF Study to Monitor the Safety and Performance of Symani System in Microsurgical Reconstructive Procedures in a Real Life Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Open Surgery
Blood Vessels, Lymphatic Ducts and Nerves
Free Flaps
Keywords: microsurgery
RASM
free flap
lymphatic ducts
Symani
Lead sponsor: MMI (Medical Microinstruments, Inc.)
Sponsor class: INDUSTRY
First posted: 2021-04-13
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: PMCF study aimed to monitor the safety, usability, performance and long-term efficacy of Symani. Furthermore, it will permit to detect potential emerging risks related to safety on the basis of clinical evidence through the observation of patients who have undergone microsurgical reconstructions using the Symani Surgical System in the usual setting of standard surgical practice.

Eligibility criteria: Inclusion Criteria:

* 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 Clinical Registry Manager at the Clinical Center as appropriate candidates for treatment with RASM in accordance with the Instruction For Use (IFU).
* Subjects who fit the criteria to perform surgery requiring reconstructions using free flaps, replantations or lymphatic reconstructions.
* Subjects who agree to have the surgery and the anesthesia.
* Subjects who voluntarily decide to participate in this registry with the surgery performed with the aid of the RASM Surgical System and sign the Informed Consent Form

Exclusion Criteria:

* 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 registry.
* Subjects belonging to vulnerable populations or ineligible to participate for other reasons by a Clinical Registry Manager at a Clinical Center.
* Subjects with pacemaker

Primary outcomes:
measure: Procedure Robotic Success
timeFrame: Procedure
Secondary outcomes:
measure: Anastomosis time
timeFrame: Procedure
measure: Intraoperative redo
timeFrame: Procedure
measure: Postoperative redo
timeFrame: 7 days
measure: Complications
timeFrame: 30 days
measure: Free Flap/Replantation Failure
timeFrame: 30 days
measure: Limb volume reduction (for lymphatic surgery)
timeFrame: 24 weeks
measure: Warm ischemia time
timeFrame: Procedure
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: LKH Salzburg, Universitätsklinik für Mund-, Kiefer- und Gesichtschirurgie
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Kiel
country: Germany
facility: Klinik für Mund-, Kiefer- und Gesichtschirurgie UKSH Kiel
city: Ludwigshafen
country: Germany
facility: BG Kliniken Ludwigshafen
city: Münster
country: Germany
facility: Fachklinik Hornheide
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Istituto Ortopedico Rizzoli Bologna
name: Marco Innocenti, Prof.
role: PRINCIPAL_INVESTIGATOR
References: