NCT04821739进行中（未招募）不适用
A Prospective Multi-Center Study of the AGN1 Local Osteo-Enhancement Procedure (LOEP) SV Kit in Patients With Vertebral Compression Fractures (VCFs)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Change in Back Pain from Baseline
研究概览
简要总结
This study is a prospective, single-arm, multi-center, European clinical study designed to evaluate the clinical performance and safety of the AGN1 LOEP SV Kit for the treatment of painful VCFs.
详细描述
A maximum of 100 subjects will be treated at up to 10 study sites across Europe. Follow up visits will be conducted at 1 day, 1 month, 3 months, 12 months and 24 months after the procedure.
Study enrollment will occur in three stages:
Stage 1: 5 subjects to evaluate safety at 3 months Stage 2: 30 subjects to evaluate safety at 3 months Stage 3: 100 subjects to evaluate safety and performance at 12 months
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is a male or female 50 years of age or older at time of study treatment.
- •Criterion omitted
- •Subject has only one (1) acute VCF. Subjects are eligible if they have an asymptomatic healed VCF at any non-target vertebral level.
- •This VCF meets all of the following criteria:
- •Fracture due to diagnosed or presumed underlying osteoporosis
- •VCF from T1 to L5 inclusive
- •Fracture age ≤6 months at time of treatment
- •Target VCF shows loss of height in the anterior or middle portion of the vertebral body of not more than 50% based on X-ray at baseline.
- •Target VCF is acute or persistent (not healed), as demonstrated by T2 weighted STIR MRI, bone scan, CT, serial radiographs, or other imaging demonstrating acuity.
- •Subject has central pain upon palpation over the spinal process at the target vertebral body.
- •Subject has failed conservative medical therapy, defined as either having a VAS back pain score of ≥ 70 mm after 24 hours to 6 weeks of conservative care or a VAS back pain score of ≥ 50 mm after 6 weeks of conservative care.
- •Subject has an Oswestry Disability Index (ODI) score of ≥ 30%.
- •Subject is capable of giving written informed consent to participate in the study.
- •The subject's willingness, ability, and commitment to participate in screening, treatment, and all follow-up evaluations for the full length of the study has been documented.
排除标准
- •Target VCF is due to underlying or suspected tumor.
- •Target VCF is due to high-energy trauma.
- •Target VCF is diagnosed as an osteonecrotic fracture.
- •Target VCF has segmental kyphosis of > 30°.
- •Target VCF is unstable including split or burst fractures.
- •Subject has had any prior surgical treatment at the target VCF or adjacent vertebral level (above or below VCF).
- •Subject has neurologic symptoms, deficits, or radiculopathy related to the VCF.
- •Subject has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated.
- •Subject has pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis).
- •Subject has spondylolisthesis > Grade 1 at target vertebral body.
- •Subject has pain due to any other condition that requires daily narcotic medication.
- •Subject has severe cardiopulmonary deficiencies.
- •Subject has a bleeding disorder.
- •Subject has a Body Mass Index (BMI) >
- •Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).
- •Subject has a history of tuberculosis spondylitis.
- •Subject has a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for five (5) years.
- •Subject is on oral or parenteral immune-suppressive drugs.
- •Subject has an active bone infection at target VCF.
- •Subject has uncontrolled diabetes mellitus, as determined by the judgment of the Investigator.
- •Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min.
- •Subject has a diagnosed calcium metabolism disorder.
- •Subject has known allergies to calcium-based bone void fillers.
- •Subject is pregnant or planning to become pregnant during participation in the study.
- •In the judgment of the Investigator, the subject is not a good study candidate (e.g., inability to maintain follow-up schedule, comorbidity or poor general physical/mental health, or drug or alcohol abuse issues).
- •Subject is currently enrolled in another interventional clinical study.
研究组 & 干预措施
Treatment with AGN1 LOEP SV Kit
Experimental
VCF is treated with the AGN1 LOEP SV Kit
干预措施: AGN1 LOEP SV Kit (Device)
结局指标
主要结局
Change in Back Pain from Baseline
时间窗: 12 months
Change in Back Pain at 12 months from Baseline as indicated by Visual Analogue Scale (VAS), measured on a continuous 100 mm line.
次要结局
未报告次要终点
研究者
研究点 (7)
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