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

Not Applicable

Not yet recruiting

• Conditions: Open Surgery; Lymphedema; Free Tissue Transfer; Microsurgery
• Interventions: Device: Symani Surgical System

• Registration Number: NCT06628219
• Lead Sponsor: MMI Spa

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-02
• Study First Posted: 2024-10-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Study Start: 2025-02-01
• Primary Completion: 2026-02-01
• Study Completion: 2030-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Free Tissue Transfer and Lymphedema Surgery Participants	Symani Surgical System	-

Primary Outcome Measures

Name	Time	Method
Clinical Success, defined as intraoperative anastomosis patency.	The duration of the participants' index procedure, from when they enter the OR to when they leave the OR (procedures typically last under 24 hours).	Clinical Success is defined as intraoperative anastomosis patency. Intraoperative anastomosis patency will be measured for each robotic anastomosis (anastomosis contains at least two robotically placed sutures) per standard of care and will be evaluated prior to closure of the procedure site during the index procedure.
Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee.	The duration of the participants' index procedure hospitalization (typically lasting under two weeks).	Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee. All device-related serious adverse events will be descriptively summarized.

Secondary Outcome Measures

Name	Time	Method
Freedom from a reoperation to revise a robotic anastomosis prior to discharge	The duration of the participants' index procedure hospitalization (typically lasting under two weeks).	Freedom from returning to the operating room for surgical revisions to an anastomosis that was deemed robotic (anastomosis contains at least two robotically placed sutures) in the index procedure. This endpoint will be evaluated at discharge for each participant.
Rate of intra-operative approach changes from robotic to manual	The duration of the participants' index procedure, from when they enter the OR to when they leave the OR (procedures typically last under 24 hours).	An intra-operative approach change is defined as a conversion from a robotic anastomosis approach to a manual anastomosis approach. This endpoint will be evaluated upon completion of the index procedure.
Technical success	The duration of the participants' index procedure, from when they enter the OR to when they leave the OR (procedures typically last under 24 hours).	Technical success is defined as freedom from device malfunction resulting in unplanned conventional suturing. Device malfunctions and the associated outcome will be collected. This endpoint will be evaluated upon completion of the index procedure.