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

MMI (Medical Microinstruments, Inc.)

Status: Begins enrollment this month

Conditions: Lymphedema of Neck; External Lymphedema; Lymphedema; Internal Lymphedema; Lymphedema of Face

Treatments: Device: Symani Surgical System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07311876

CDC-00148

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Head and Neck Lymphedema

Experimental group

Description:

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.

Treatment:

Device: Symani Surgical System