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

NCT ID: NCT06628219

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2030-02-01

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.

Conditions

Open Surgery; Lymphedema; Free Tissue Transfer; Microsurgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Free Tissue Transfer, Therapeutic Lymphatic Surgery, Prophylactic Lymphatic Surgery Participants

Group Type: EXPERIMENTAL

Symani Surgical System

Intervention Type: DEVICE

The Symani Surgical System (Symani) is designed for open microsurgery procedures, featuring articulated and interchangeable instruments.

Interventions

Symani Surgical System

The Symani Surgical System (Symani) is designed for open microsurgery procedures, featuring articulated and interchangeable instruments.

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• 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

• Patients with buried flaps
• Multiple flaps planned for the procedure

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MMI (Medical Microinstruments, Inc.)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Clinical Operations

Role: CONTACT

Phone: 8336646276

Email: clinical.ops@mmimicro.com

Other Identifiers

CDC-00134

Identifier Type: -

Identifier Source: org_study_id