A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons

NCT06725030 | Recruiting DMC FDA Device

• 1 other identifier: CDC-00136
• Study Type: observational
• Target: 455
• Locations: 1 country
• Sites: 4

Brief Summary

The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery. The primary endpoints are:

• Effectiveness- Rate of intraoperative anastomosis patency at first attempt.
• Safety- Freedom from device-related adverse events. 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 lymphedema procedure, they will be asked to undergo a questionnaire as part of the study.
• Participants will be asked to comply with the follow-up visits and complete all study procedures/questionnaires as outlined in the protocol.

Conditions

Open Surgery; Lymphedema; Free Tissue Transfer; Microsurgery; Anastomosis, Surgical

Outcome Measures

Primary Outcomes (2)

• Freedom from device-related adverse events from the start of the index procedure through 30-days post index procedure as adjudicated by a Clinical Events Committee

  All adverse events will be evaluated from the start of the index procedure through 30-days post index procedure. Adverse events will be reviewed by a Clinical Events Committee (CEC) to determine probable or causal relationships with the device. All device-related serious adverse events will be summarized descriptively.

  From participants index procedure through 30-days post index procedure.

• Intraoperative anastomosis patency at first attempt.

  Intraoperative anastomosis patency will be measured for each robotic anastomosis per standard of care and will be evaluated after the first attempt of the anastomosis during the index procedure.

  The duration of the participants index procedure.

Secondary Outcomes (5)

• Intraoperative anastomosis patency prior to closure.

  The duration of participants index procedure.

• Anastomosis suturing time (including robotic time and manual time).

  The duration of participants index procedure.

• Number of robotic and manual stitches per anastomosis.

  The duration of participants index procedure.

• Procedure time.

  The duration of participants index procedure.

• Technical Success.

  The duration of participants index procedure.

Study Arms (2)

Free Tissue Transfer Surgery

Device: Symani Surgical System

Lymphovenous Anastomosis Surgery

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 Surgery; Lymphovenous Anastomosis Surgery

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients selected for the PRECISE Study will be adults with a clinical indication for a microsurgical anastomosis of vessels between 0.1 and 2.5 mm in conjunction with open free flap surgery of the breast or extremities and/or lymphovenous anastomosis surgery of the extremities.

You may qualify if:

• At least 22 years of age
• Patient agrees to participate in the study, return for all required follow-up visits, complete all study procedures, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic assisted procedure
• Patient has a clinical indication for a microsurgical anastomosis of vessels between 0.1 and 2.5 mm in conjunction with open free-flap surgery of the breast or extremities and/or lymphovenous anastomosis surgery of the extremities
• Investigator deems the candidate acceptable for free flap transfer surgery and/or lymphovenous anastomosis surgery with a robotic assisted microsurgical anastomosis in accordance with the Symani System's Instructions for Use (IFU)
• Free Tissue Transfer Surgery: N/A
• Lymphovenous Anastomosis Surgery
• Swelling of one limb that is not completely reversed by elevation or compression
• Stage I-II lymphedema at screening, based on the International Society of Lymphology (ISL) staging system
• At least one of the following positive quantitative measurements:
• Volumetry differential between affected limb and contralateral limb must be at least 10% of the other
• Bioimpedance (L-Dex) differential, if feasible, between affected limb and contralateral limb of at least 10 units
• Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines, for at least 12 weeks prior to screening, including use of compression garments for at least 12 weeks without change in regimen
• Willingness to comply with recommended regimen of self-care, with consistent use of appropriately sized compression garments from screening through the entire study duration (through the 3-month follow-up visit).

You may not qualify if:

• Patients who are incapable and/or unwilling to provide informed consent
• Active systemic infection under treatment with intravenous antibiotics
• Clinically significant cardiovascular, digestive, respiratory, endocrine, 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
• Currently receiving chemotherapy or radiation therapy
• History of chronic kidney disease
• History of chronic liver disease
• 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 ineligible to participate for other reasons in the judgement of the investigator
• Free Tissue Transplant Surgery:
• Patients with buried flaps
• Multiple flaps planned for the procedure
• Lymphovenous Anastomosis Surgery:

Sponsors & Collaborators

• MMI (Medical Microinstruments, Inc.): lead

Study Sites (4)

Cedars Sinai Medical Center

Beverly Hills, California, 90048, United States

RECRUITING

Yale New Haven Hospital

New Haven, Connecticut, 06511, United States

RECRUITING

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Bohdan Pomahac, MD

  Yale New Haven Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Operations

CONTACT

8336646276; clinical.ops@mmimicro.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: September 22, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (4)