Safety and Efficacy Assessment of the VERTICA® - a Radio Frequency Device for the Treatment of Erectile Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 201
- 试验地点
- 6
- 主要终点
- A significant change from baseline in the mean International Index of Erectile Function - Erectile Function domain (IIEF-EF) scores at 12 weeks, within the VERTICA Active treatment group.
研究概览
简要总结
Adult subjects with mild to moderate and moderate ED who meet the study eligibility criteria will be enrolled in the study. The enrolled subjects will be randomized by a 1:1 ratio to receive the Active or Sham VERTICA® treatment. Baseline assessments will include collection of demographic data, medical history, concomitant medications and baseline clinical examinations. The initial treatment session will be performed in a clinical setting simulating home use to determine proper device use and to evaluate device tolerability, followed by continued home use of the device for a total of 6 months. Patients will be instructed to attempt sexual activity periodically over the course of the study. Every time a sexual intercourse is attempted, the patient will be requested to complete an event log using validated assessments. Patients will present for monthly follow-up visits, during which safety will be evaluated and additional efficacy assessments will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Study personnel, including the investigator and raters and study subjects will be blinded to the treatment assignment (active vs. sham)
入排标准
- 年龄范围
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult, heterosexual, males between 22 and 85 years of age
- •Subjects diagnosed with organic ED for at least 3 months, according to the American Urology Association (AUA) Guideline Statement 1 (as described in Section 8.1.1 of the study protocol).
- •Subjects with an IIEF-EF score between 11-21
- •Steady relationship for at least 3 months
- •Subject is sexually active, with at least weekly sexual intercourse attempts or 6 times a month
- •Subject is willing to sign informed consent and follow study protocol procedures
- •Subject has a smartphone
排除标准
- •Castrate and late onset hypogonadism
- •History of Priapism or Peyronie's Disease
- •Surgery or radiotherapy of the pelvic region
- •Anatomic penile deformations or penile prosthesis
- •Treatment with antiandrogens
- •Previous whole gland treatment of the prostate (Cryoablation, HIFU, external beam radiation of seed implantation, Radical prostatectomy any approach, etc.)
- •History of urothelial or colorectal cancer
- •Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury, pelvic neuropathy
- •Evidence of neurogenic bladder or an indwelling Foley catheter or clean intermittent catheterization (CIC) within 30 days
- •Subjects who are taking anticoagulation or anti-platelet therapy
- •History of psychiatric disorders, premature ejaculation and drug or alcohol abuse
- •Subjects who are incarcerated
- •Subjects who are cognitively challenged
- •Serious heart or lung disease
- •Pregnant partner
研究组 & 干预措施
Active
干预措施: VERTICA Active device (Device)
Sham
干预措施: VERTICA Sham device (Device)
结局指标
主要结局
A significant change from baseline in the mean International Index of Erectile Function - Erectile Function domain (IIEF-EF) scores at 12 weeks, within the VERTICA Active treatment group.
时间窗: 12 weeks
The IIEF-EF total score ranges between 6 to 30. A higher total score indicates relatively better erectile functioning.
A significant difference in the mean change from baseline in the International Index of Erectile Function - Erectile Function domain (IIEF-EF) scores at 12 weeks, between the treatment groups.
时间窗: 12 weeks
The IIEF-EF total score ranges between 6 to 30. A higher total score indicates relatively better erectile functioning.
次要结局
未报告次要终点