Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 14
- 主要终点
- To characterize the TNM device implant procedure
研究概览
简要总结
This is a prospective, multicenter, feasibility study to characterize the procedure for the implantable TNM device in subjects with overactive bladder.
详细描述
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
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
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects 18 years of age or older
- •Have a diagnosis for at least 6 months of OAB
- •No OAB pharmacotherapy for 2 weeks prior to the baseline voiding diary
- •Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system and comply with the study protocol
- •Willing and able to provide signed and dated informed consent
排除标准
- •Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
- •Severe uncontrolled diabetes
- •History of urinary retention within the previous 6 months
- •Current symptomatic urinary tract infection
- •Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
- •Current urinary tract mechanical obstruction
- •Have knowledge of planned magnetic resonance imaging (MRIs) or diathermy
- •History of a prior implantable tibial neuromodulation system
- •Skin lesions or compromised skin integrity at the implant site
- •Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device
- •Previous pelvic floor surgery in the last 6 months
- •Women who are pregnant or planning to become pregnant
- •Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
- •Any subject who is considered to be part of a vulnerable patient population.
- •Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.** **Subjects in concurrent studies can only be enrolled with permission from Medtronic.
- •Contact Medtronic's study manager to determine if the subject can be enrolled in both studies.
结局指标
主要结局
To characterize the TNM device implant procedure
时间窗: 14 days
This information will be collected through a series of questions for participating investigators via a case report form at implant through the 14-day follow-up visit.
To characterize the TNM device initial system use
时间窗: 14 days
This information will be collected through programming and device data at implant through the 14-day follow-up visit.
次要结局
未报告次要终点