Clinical Lymphedema Evaluation - Advancing Reconstruction of Head and Neck Lymphatics With Symani

NCT07311876 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CDC-00148
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during open lymphatic reconstruction in the head and neck.

Conditions

Internal Lymphedema; External Lymphedema; Lymphedema of Neck; Lymphedema; Lymphedema of Face

Keywords

lymphedema; head and neck lymphedema; symani

Outcome Measures

Primary Outcomes (2)

• Intraoperative anastomosis patency prior to closure.

  Intraoperative anastomosis patency prior to closure will be measured for each robotic anastomosis using indocyanine green (ICG) fluorescence imaging and will be evaluated prior to closure of the procedure site during the index procedure.

  The duration of the participants' index procedure.

• Freedom from device-related adverse events

  All adverse events will be evaluated from the start of the index procedure through 30 days post index procedure.

  The duration of the participants' index procedure through 30 days.

Secondary Outcomes (10)

• Change in flow pathways

  From the pre-operative visit through 6 months post index procedure.

• Change in MD Anderson Lymphedema Rating Scale for facial lymphedema

  From the pre-operative visit through 6 months post index procedure.

• Assessment of Lymphedema of the Head and Neck Area (ALOHA) method for lymphedema measurement

  From the pre-operative visit through 6 months post index procedure.

• Change in Head and Neck Lymphedema and Fibrosis Symptom Inventory

  From the pre-operative visit through 6 months post index procedure.

• Change in internal lymphedema

  From the pre-operative visit through 6 months post index procedure.

Study Arms (1)

Head and Neck Lymphedema

EXPERIMENTAL

The patients selected for the CLEAR Study will be adults over 22 years of age with a clinical indication for a microsurgical anastomosis of vessels between 0.1 and 2.5 mm in conjunction with lymphatic reconstruction of the head and neck.

Device: Symani Surgical System

Interventions

Symani Surgical System DEVICE

Symani® Surgical System is intended to perform surgical techniques during open microsurgical procedures.

Head and Neck Lymphedema

Eligibility Criteria

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

You may qualify if:

• At least 22 years of age
• Patients with acquired head and neck lymphedema with external lymphedema or both external and internal lymphedema
• 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 lymphatic reconstruction of the head and neck
• Patient has been compliant with complete decongestive therapy (CDT) for at least 4 weeks
• Patient has undergone lymphatic mapping of the head and neck and functional lymphatic structures for reconstruction have been identified
• Investigator deems the candidate acceptable for lymphatic reconstruction with a robotic-assisted microsurgical anastomosis in accordance with the Symani System's Instructions for Use (IFU)
• Willingness to comply with recommended regimen of self-care, with consistent use of manual lymph drainage and/or appropriately sized compression garments from screening through the entire study duration (through the 6-month follow-up visit).

You may not qualify if:

• Patient who is incapable and/or unwilling to provide informed consent
• Patients with irreversible head and neck lymphedema, defined as stage 3 of the MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale
• 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 investigator's discretion
• Known history of significant bleeding, coagulopathy, or Von Willebrand's disease
• Currently receiving chemotherapy or radiation therapy (uncontrolled tumor)
• A history of malignancy or cancer treatment within the past 6 months (tumor control)
• Patient with unsatisfactory manual lymphatic drainage and/or compression garments for at least six months
• Patient with prior lymphatic reconstruction in the targeted head \& neck area
• Patient's lymphatic disease is due to lipedema
• Patients with other medical conditions that could result in symptoms which overlap symptoms of lymphedema (e.g., thrombosis in the external or internal jugular vein)
• Current infection in the head \& neck area in which lymphedema is present
• Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes
• Patient is ineligible to participate for other reasons in the judgement of the investigator

Sponsors & Collaborators

• MMI (Medical Microinstruments, Inc.): lead

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

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

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: December 31, 2025
• Study Start: April 28, 2026
• Primary Completion (Estimated): May 28, 2027
• Study Completion (Estimated): October 28, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03