NCT06456125进行中（未招募）不适用
Safety and Efficacy Of Amber Peripheral Liquid Embolic System: a First-in-HumAn & PivotaL Study
LVD Biotech S.L1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年6月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Rate of complete vascular occlusion (Stage II)
研究概览
简要总结
A prospective, single-arm, multicenter, open-label, First-in-Human & Pivotal Study to assess the safety and efficacy of amber SEL-P in 70 patients requiring peripheral embolization: vascular anomalies, hemorrhages, aneurysms, and pseudoaneurysms, varicose veins, portal vein, hypervascular tumors, type -II endoleaks, and pathological organs.
The study will be divided into two consecutive stages. Stage I will be dedicated to testing the device's safety, followed immediately by stage II, aimed to test the device's efficacy. The overall study sample will be used to assess the device safety and efficacy in all the enrolled participants.
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
- 18 Years 至 94 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 and < 95 years presenting with one of the following indications:
- •Varicose vein embolization:
- •Pelvic congestion syndrome (uterine venous engorgement, and/or moderate or severe engorgement of the ovarian plexus, and/or filling of the veins across the midline or filling of vulvar or thigh varicosities, and/or reflux throughout the entire course of the ovarian vein.
- •Varicocele (symptomatic varicocele, and/or infertility or subfertility).
- •Varicose veins in patients with portal hypertension undergoing Transjugular Intrahepatic Portosystemic Shunt (TIPS) that require embolization.
- •Type II endoleak: Persistent type II endoleak and/or an associated sac expansion > 5 mm after 6 months or 10 mm after 12 months.
- •Insufficient liver remnant requiring portal vein embolization (PVE) before liver resection: Predicted insufficient liver remnant after surgery (≤20% in a normal liver, ≤30% in liver with intermediate disease without cirrhosis, and ≤40% in liver with cirrhosis)
- •Active arterial hemorrhage and/or pseudoaneurysm: Uncontrolled massive hemorrhage caused by tumor, trauma or arteriovenous shunt formation (congenital or acquired), and/or up to 3 bleeding sites in the same organ or anatomic region
- •Pathologic organ (i.e. non-functioning transplanted kidney, preoperative hip replacement, hypersplenism conditioning low platelet count; excluding brain)
- •Hypervascular tumors
- •Vascular anomalies
排除标准
- •Patients with known hypersensitivity or allergy to amber-20, dimethylsulfoxide (DMSO) solvent, or contrast agent
- •Previously failed embolization procedure, except for those treated with coils
- •Patient in whom according to the investigator criteria a complete vascular occlusion would not be feasible in a single procedure
- •Any condition that exposes the patient to a high risk for complications according to the investigator's criteria (e.g., but not limited to, non-correctable coagulopathy, uncontrolled sepsis, underlying life-threatening condition, etc.)
- •Patients participating in another interventional study that has not completed it primary endpoint assessment.
- •Pregnant or breastfeeding women.
- •Patients unable or unwilling to provide a written informed consent.
- •Recurrent varicose vein embolization
- •Type II endoleak: with high flow or reflux that cannot be prevented using coils or balloon microcatheter, and high risk of medullar ischemic damage
- •Active arterial bleeding and/or pseudo aneurysm with: severe hemodynamical instability (e.g., but not limited to, sustained hypotension [mean arterial pressure < 60 mmHg], tachycardia >120 beats/minute, requirement of high doses of vasopressors, etc.) at the moment of the procedure, and/or hb < 8 g/dL before the procedure, and/or retroperitoneal hemorrhages or hemoptysis, identification of spinal or medullar vessels.
- •Central nervous system and central circulatory system vascular anomalies.
- •Iodine contrast allergy
结局指标
主要结局
Rate of complete vascular occlusion (Stage II)
时间窗: Embolization procedure day
Rate of complete vascular occlusion as defined by angiography at the end of the procedure.
Peri-procedure serious adverse events related to amber SEL-P (Stage I)
时间窗: Up to 24 hours after embolization procedure
Rate of peri-procedure serious adverse events related to amber SEL-P (device-related but not related to the procedure) at 24 hours, adjudicated by an independent clinical events committee.
次要结局
- Rate of peri-procedure serious adverse events related to amber SEL-P (Stage II)(Up to 24 hours after embolization procedure)
- Rate of complete vascular occlusion according clinical indication (Stage II)(Embolization procedure day)
- Rate of any peri-procedure adverse events related to amber SEL-P (Stage I)(Up to 24 hours after embolization procedure)
研究者
研究点 (1)
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