NCT05625984已完成不适用
Multi-centre, Open-label, First-in-man Study With Fascigel Used in Adult Patients Suffered From Back Pain
Contipro Pharma a.s.3 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年10月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 3
- 主要终点
- - Pain management
研究概览
简要总结
The product is a Class III Medical Device. Structure is made by 1% sodium hyaluronate polysaccharide in normal saline solution. The device intended use is to help treat back pain by lubricating fascia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Back pain (VAS above 4 cm)
- •Limited range of motion
- •Duration of pain for over 3 months
- •Patient willing and able to provide the written consent
- •Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study
排除标准
- •State after back surgery
- •BMI > 35
- •Age < 18 years
- •Pregnant or lactating woman
- •Patient in terminal stage of living
- •Patient with known hypersensitivity or allergy to any of substances contained in Medical Device
- •Patient participating in the intervention clinical study
- •Alcohol or drug abuse
- •Patient undergoing chronic coagulation therapy
研究组 & 干预措施
Fascigel injection application
Experimental
Device is administered injected interfascially in the concerned place (low back) in multiple places laterally.
干预措施: Fascigel (Device)
结局指标
主要结局
- Pain management
时间窗: 3 months
Visual Analogue Scale - 0-100 - higher scores mean a worse outcome
次要结局
未报告次要终点
研究者
研究点 (3)
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