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

NCT06628219 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CDC-00134
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Clinical Success, defined as intraoperative anastomosis patency.

  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.

  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).

• Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee.

  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.

  The duration of the participants' index procedure hospitalization (typically lasting under two weeks).

Secondary Outcomes (3)

• 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).

• 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).

• 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).

Study Arms (1)

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

EXPERIMENTAL

Device: Symani Surgical System

Interventions

Symani Surgical System DEVICE

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

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

Eligibility Criteria

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

You may qualify if:

• 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):
• Volumetry differential between diseased limb and contralateral limb must be at least 10% of the other
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MMI (Medical Microinstruments, Inc.): lead

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Clinical Operations

CONTACT

8336646276; clinical.ops@mmimicro.com

Study Design

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

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 4, 2024
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2030
• Last Updated: December 10, 2024

Record last verified: 2024-12