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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lymphedema; Lymphedema of Face; Internal Lymphedema; External Lymphedema; Lymphedema of Neck
• Intervention / Treatment: Device: Symani Surgical System

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. At least 22 years of age
2. Patients with acquired head and neck lymphedema with external lymphedema or both external and internal lymphedema
3. 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
4. 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
5. Patient has been compliant with complete decongestive therapy (CDT) for at least 4 weeks
6. Patient has undergone lymphatic mapping of the head and neck and functional lymphatic structures for reconstruction have been identified
7. 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)
8. 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).

Exclusion Criteria:

1. Patient who is incapable and/or unwilling to provide informed consent
2. Patients with irreversible head and neck lymphedema, defined as stage 3 of the MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale
3. Active systemic infection under treatment with intravenous antibiotics
4. 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
5. Known history of significant bleeding, coagulopathy, or Von Willebrand's disease
6. Currently receiving chemotherapy or radiation therapy (uncontrolled tumor)
7. A history of malignancy or cancer treatment within the past 6 months (tumor control)
8. Patient with unsatisfactory manual lymphatic drainage and/or compression garments for at least six months
9. Patient with prior lymphatic reconstruction in the targeted head & neck area
10. Patient's lymphatic disease is due to lipedema
11. 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)
12. Current infection in the head & neck area in which lymphedema is present
13. Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes
14. Patient is ineligible to participate for other reasons in the judgement of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Head and Neck Lymphedema; 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; Symani® Surgical System is intended to perform surgical techniques during open microsurgical procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in flow pathways	Change in flow pathways will be assessed by an ICG lymphangiography	From the pre-operative visit through 6 months post index procedure.
Change in MD Anderson Lymphedema Rating Scale for facial lymphedema	Scale ranges from 0-3, the higher score indicating worse disease state.	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	It contains 33 items (symptoms) which are answered Yes or No. If the response is Yes to any given item, the patient is asked to rate the intensity of the symptom on a 5-point Likert scale. Each symptom then receives a score ranging from 0 (does not experience the symptom) to 5 (experiences the symptom with severe intensity).	From the pre-operative visit through 6 months post index procedure.
Change in internal lymphedema	Assessed by Fiberoptic Endoscopic Evaluation of Swallowing (FEES) Examination	From the pre-operative visit through 6 months post index procedure.
Technical Success	as freedom from any device malfunction resulting in unplanned conventional (manual) suturing	The duration of the participants' index procedure.
All-cause readmission rates		The duration of the participants' index procedure through 30 days post index proceudre.
Procedure-related adverse events (AEs) rate		The duration of the participants' index procedure through 30 days post index proceudre.
Serious adverse events (AEs) rate		The duration of the participants' index procedure through 30 days post index proceudre.
Anastomosis-specific reoperation rate		The duration of the participants' index procedure through 30 days post index proceudre.

Collaborators and Investigators

• Sponsor: MMI (Medical Microinstruments, Inc.)

Study record dates

Study Major Dates

• Study Start (Estimated): April 28, 2026
• Primary Completion (Estimated): May 28, 2027
• Study Completion (Estimated): October 28, 2027

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: lymphedema; head and neck lymphedema; symani
• Additional Relevant MeSH Terms: Lymphatic Diseases; Hemic and Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: CDC-00148

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes