NCT07311876招募中不适用
Clinical Lymphedema Evaluation - Advancing Reconstruction of Head and Neck Lymphatics With Symani
MMI (Medical Microinstruments, Inc.)1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年6月19日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Intraoperative anastomosis patency prior to closure.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Symani Surgical System (Device)
结局指标
主要结局
Intraoperative anastomosis patency prior to closure.
时间窗: 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
时间窗: 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.
次要结局
- 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.)
- Technical Success(The duration of the participants' index procedure.)
- Change in Head and Neck Lymphedema and Fibrosis Symptom Inventory(From the pre-operative visit through 6 months post index procedure.)
- Procedure-related adverse events (AEs) rate(The duration of the participants' index procedure through 30 days post index proceudre.)
- Change in internal lymphedema(From the pre-operative visit through 6 months post index procedure.)
- All-cause readmission rates(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.)
研究者
研究点 (1)
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