Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 11
- 主要终点
- Character of usability and acceptance of the ATI Neurostimulation System, as evaluated by the following:
研究概览
简要总结
The primary objectives of the Registry are to:
- Monitor the transfer of the ATI Neurostimulation System and its safety/clinical performance to a larger number of centers in the post market phase and
- Collect additional evidence to support reimbursement and clinical acceptance and long term follow up
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject meets CE marked labeling for cluster headache.
- •Subject's typical cluster headache bouts last a minimum of 16 weeks, in the opinion of the Investigator.
- •Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency or dose except to manage tolerability) from Study Enrollment through the completion of the Therapy Evaluation Period.
- •Subject has the ability to read, comprehend and to reliably record information as required by the Protocol.
- •Subject is able to provide written informed consent prior to participation in the study.
排除标准
- •Subject has had a change in type, dosage or frequency of taking preventive headache medications < one (1) month prior to Study Enrollment.
- •Per the CE marked labeling: In the opinion of the Investigator, subject has bony facial deformities, inappropriate surgical anatomy or has had facial surgery in the surgical area on the same side as the planned surgery that would prevent the proper placement of the ATI Neurostimulator.
- •Subject has other significant pain problem that might confound the study assessments in the opinion of the Investigator.
结局指标
主要结局
Character of usability and acceptance of the ATI Neurostimulation System, as evaluated by the following:
时间窗: Through study completion
1. Implantation of ATI Neurostimulator within the pterygopalatine fossa 2. Explant and lead-revision rates and reasons
Characterization of patient response to therapy, as evaluated by the following:
时间窗: Through study completion
1. Patient acceptance of the therapy 2. Responder Analysis, where a responder is any patient who achieves Effective Therapy in at least 50% of evaluable attacks, a 50% attack frequency attack decrease relative to Baseline, or both 3. Disability and Quality of Life as characterized by the HIT-6 and SF-36v2 compared to Baseline 4. Subject Overall Evaluation of Therapy 5. Change in use of acute medications compared to Baseline 6. Change in preventive medication use and work status compared to Baseline
次要结局
未报告次要终点