Pilot Clinical Study to Assess Safety and Feasibility of a New Implantable Device in the Management of Limb Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Occurrence, frequency and severity of device-related adverse events
研究概览
简要总结
The present study is a first-in-man, single arm, open-label, single center study to assess feasibility and safety of a novel implantable device, LymphoPilot, in patients suffering from secondary upper limb or lower lymphedema.
详细描述
The study consists in a first-in-man clinical investigation for LymphoPilot, an investigational implantable medical device. LymphoPilot is composed of an implanted part and an external wearable device. The implanted part (pump, drainage catheter and output catheter), is implanted in the subcutaneous tissue of the arm or leg and drains excess fluids to the supraclavicular or abdominal subcutaneous tissue, where fluids are naturally reabsorbed by the healthy lymphatic and venous system. The external part consists in a wearable controller used to activate the implanted pump.
The subcutaneous implantation of the device is performed in loco-regional or general anesthesia, in ambulatorial settings, and the patient is dismissed from the hospital on the same day of the procedure.
The device is activated in the postoperative room by placing the external wearable device on patient's limb, in proximity of the implanted pump. Patients are required to wear the external controller continuously throughout the study, except 30 minutes per day, to allow taking a shower/bath.
Follow-up visits are planned 1, 4 and 8 weeks after device implantation. The implanted device is removed with a surgical procedure in local anesthesia 8 weeks after device implantation, and 2 additional follow-up visits are planned after device removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients, 18 years and older
- •Patients with unilateral secondary upper or lower limb lymphedema.
排除标准
- •Active cellulitis/infection
- •Lymphedema associated with active cancer requiring chemotherapy or radiotherapy
- •Motor and sensitive neurological deficiency
- •Post-operative edema (i.e. acute edema following breast cancer related surgery)
- •Any contraindication to surgery or to loco-regional or general anesthesia
- •Patient participating in any other clinical study
- •Patient unable to provide informed consent
- •Patient with pacemaker
- •Pathologies associated with an overload of the cardiac system
- •Poor wound healing
- •Pregnancy or breastfeeding
- •Known intolerance to implantable devices
- •Known allergies to silicone
- •Patient needing magnetic therapy
- •Any other condition that according to the principal investigator makes the patient unsuitable for the participation in the trial
- •Patient refusing to receive information about incidental findings on her health status discovered during the clinical investigation
- •L-Dex score lower than 6.5 at screening
结局指标
主要结局
Occurrence, frequency and severity of device-related adverse events
时间窗: From enrollment until final visit, 4 weeks after device removal.
Occurrence, frequency and severity of device-related adverse events are used to evaluate device safety
次要结局
- Device functionality evaluated via ultrasound imaging(At day 1 (implant surgery), day 7, day 28 and day 56)
- Limb volume(At day 0 (baseline), day 7, day 28, day 56, day 66, day 84)
- Lower extremity function(At day 0 (baseline) and at day 56)
- Role limitations due to physical health evaluated via validated SF-36 questionnaire(At day 0 (baseline) and at day 56)
- Upper extremity function(At day 0 (baseline) and at day 56)
- Physical functioning evaluated via validated SF-36 questionnaire(At day 0 (baseline) and at day 56)
- L-Dex score(At day 0 (baseline), day 7, day 28, day 56, day 66, day 84)
- Social functioning evaluated via validated SF-36 questionnaire(At day 0 (baseline) and at day 56)
- Pain evaluated via validated SF-36 questionnaire(At day 0 (baseline) and at day 56)
- General health evaluated via validated SF-36 questionnaire(At day 0 (baseline) and at day 56)
- Role limitations due to emotional problems evaluated via validated SF-36 questionnaire(At day 0 (baseline) and at day 56)
- Emotional well-being evaluated via validated SF-36 questionnaire(At day 0 (baseline) and at day 56)
- Quality of life evaluated via validated LYMQOL-leg questionnaire(At day 7 and at day 56)
- Energy/fatigue evaluated via validated SF-36 questionnaire(At day 0 (baseline) and at day 56)
- Quality of life evaluated via validated LYMPH-ICF-UL questionnaire(At day 7 and at day 56)
- Ease of use of the device(At day 7 and at day 56)