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

MMI Spa

Status

Not yet enrolling

Conditions

Microsurgery

Lymphedema

Free Tissue Transfer

Open Surgery

Treatments

Device: Symani Surgical System

Study type

Interventional

Funder types

Industry

Identifiers

NCT06628219

CDC-00134

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults, according to the local law
Patient agrees to participate in the study, return for all required follow-up visits, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic assisted procedure
Patient with a clinical indication for a microsurgical anastomosis for a free flap transfer surgery and/or lymphedema surgery
Investigator considers candidate acceptable for free flap transfer surgery and/or lymphatic surgery with a robotic assisted microsurgical anastomosis in accordance with the Symani System IFU

Inclusion Criteria for Therapeutic Lymphatic Patients:

For lymphedema of the extremities, swelling of lymphedema that is not completely reversed by decongestion therapy modalities. (Not applicable for patients with lymphedema of the head and neck)
For lymphedema of the extremities, at least one of the following positive quantitative measurements (not applicable for patients with lymphedema of the head and neck):
1. Volumetry differential between diseased limb and contralateral limb must be at least 10% of the other
2. Bioimpedance (L-Dex) differential, if feasible, between diseased limb and contralateral limb of at least 10 units
Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 12 weeks prior to screening
Willingness to comply with recommended regimen of self-care, with consistent use of compression garments from screening through the entire study duration
Patient must be diagnosed with Lymphedema
Patient must have a body mass index (BMI) of ≤ 35

Inclusion Criteria for Prophylactic Lymphatic Patients:

In the opinion of the investigator, the patient has at least one identifiable indication for prophylactic lymphatic surgery.
Patient must have a body mass index (BMI) of ≤ 35

Exclusion criteria

Patients who are not capable and/or unwilling to provide informed consent
Clinically significant cardiovascular, digestive, respiratory, endocrine, liver or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigators discretion.
Known history of significant bleeding, coagulopathy, or Von Willebrand's disease
Patients with implanted pacemaker
Planned vein graft (either venous or arterial)
Previously documented history of chronic kidney disease (eGFR ≤ 30)
Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes
Patients belonging to vulnerable populations, such as pregnant women, or patients ineligible to participate for other reasons in the judgement of the investigator

Exclusion Criteria for Free Tissue Transfer Patients:

Patients with buried flaps
Multiple flaps planned for the procedure

Exclusion Criteria for Therapeutic Lymphatic Patients:

Patients with venous edema (arising from increased capillary filtration)
Patients with other medical conditions that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure
Current infection in the affected area of lymphedema
Current evidence of malignancy
Known iodine sensitivity
Patient's lymphatic disease is due to lipedema
Patients with bilateral lymphedema or lymphedema in multiple anatomical locations

Exclusion Criteria for Prophylactic Lymphatic Participants:

Patients for whom prophylactic surgery on more than one limb is planned
Known iodine sensitivity
Patients with post-thrombotic syndrome, arterial insufficiency, deep vein thrombosis or any other medical condition that could make them ineligible to participate in the judgment of the investigator
Patients diagnosed with lymphedema
Patients who have received prior radiation therapy to the affected limb where the investigator believes the amount or extent of radiation could compromise the success of prophylactic lymphatic surgery

Intraoperative Exclusion Criteria:

Any presenting condition discovered intraoperatively that, in the opinion of the investigator, would make participating in this study not in the patient's best interest
The patient does not have at least two robotic sutures attempted during the index procedure