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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Intraoperative anastomosis patency prior to closure. [Срок оценки: The duration of the participants' index procedure.]
• Freedom from device-related adverse events [Срок оценки: The duration of the participants' index procedure through 30 days.]

Вторичные конечные точки (10)

• Change in flow pathways [Срок оценки: From the pre-operative visit through 6 months post index procedure.]
• Change in MD Anderson Lymphedema Rating Scale for facial lymphedema [Срок оценки: 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 [Срок оценки: From the pre-operative visit through 6 months post index procedure.]
• Change in Head and Neck Lymphedema and Fibrosis Symptom Inventory [Срок оценки: From the pre-operative visit through 6 months post index procedure.]
• Change in internal lymphedema [Срок оценки: From the pre-operative visit through 6 months post index procedure.]
• Technical Success [Срок оценки: The duration of the participants' index procedure.]
• All-cause readmission rates [Срок оценки: The duration of the participants' index procedure through 30 days post index proceudre.]
• Procedure-related adverse events (AEs) rate [Срок оценки: The duration of the participants' index procedure through 30 days post index proceudre.]
• Serious adverse events (AEs) rate [Срок оценки: The duration of the participants' index procedure through 30 days post index proceudre.]
• Anastomosis-specific reoperation rate [Срок оценки: The duration of the participants' index procedure through 30 days post index proceudre.]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• University Hospital Schleswig-Holstein — Kiel

Идентификаторы

NCT: NCT07311876 · CDC-00148

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗