External Lymphedema, Internal Lymphedema, Lymphedema, Lymphedema of Face, Lymphedema of Neck
Conditions
Keywords
lymphedema, head and neck lymphedema, symani
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.
Interventions
DEVICESymani Surgical System
Symani® Surgical System is intended to perform surgical techniques during open microsurgical procedures.
Sponsors
MMI (Medical Microinstruments, Inc.)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative anastomosis patency prior to closure. | The duration of the participants' index procedure. | 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. |
| Freedom from device-related adverse events | The duration of the participants' index procedure through 30 days. | All adverse events will be evaluated from the start of the index procedure through 30 days post index procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in flow pathways | From the pre-operative visit through 6 months post index procedure. | Change in flow pathways will be assessed by an ICG lymphangiography |
| Change in MD Anderson Lymphedema Rating Scale for facial lymphedema | From the pre-operative visit through 6 months post index procedure. | Scale ranges from 0-3, the higher score indicating worse disease state. |
| 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. | 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). |
| Change in internal lymphedema | From the pre-operative visit through 6 months post index procedure. | Assessed by Fiberoptic Endoscopic Evaluation of Swallowing (FEES) Examination |
| Technical Success | The duration of the participants' index procedure. | as freedom from any device malfunction resulting in unplanned conventional (manual) suturing |
| 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. | — |
Countries
Germany
Contacts
CONTACTClinical Operations
PRINCIPAL_INVESTIGATORMartin Laudien
University Hospital Schleswig-Holstein
PRINCIPAL_INVESTIGATORJamie Ku
The Cleveland Clinic
Outcome results
None listed