Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans with Urinary Incontinence - NSM-001

euSpera Medical Inc.0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•Patient must be eligible for treatment and indicated for the Medtronic InterStim® system or InterStim® II (implantable pulse generator and lead).
•Patient wishes to undergo an InterStim® or InterStim® II implant procedure after this acute study.
•Patient must be in good general health in the opinion of the Investigator.
•Patient is able to understand and has voluntarily signed and dated the Ethics Committee approved informed consent form prior to initiation of any screening or study-specific procedures.
•Patient must be minimum 18 years and maximum 65 years of age.

•Patient has any of the contraindications for the InterStim® system or InterStim® II system:
•o Previous sacral surgery
•o Neurological conditions
•o Neurogenic bladder
•o Neurogenic detrusor over activity
•o Multiple Sclerosis
•o Spinal cord injury
•o Stress urinary incontinence
•o Primary pelvic pain
•o Pregnant as determined by urine pregnancy test during screening on the day of the procedure or plan to become pregnant
•o Pelvic trauma
•o Body Mass Index (BMI) below 18.5 or above 30
•o Any other contraindication is left to the Investigator*s discretion

发起方

euSpera Medical Inc.