Efficacy & Safety of a 2nd Series of Low Intensity Shock Waves for ED on Partial Responders to First Treatment
NCT01601262 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2012-07-26
Summary
Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply who respond to oral therapy (PDE-5 inhibitors). The current study will check the Efficacy and Safety of a Second Series of LISW Treatment for Erectile Dysfunction Patients Who Were Partial Responders to the Initial Treatment.
Conditions
Interventions
- DEVICE
-
Low Intensity Extracorporeal Shock waves (Cardiospec 1000)
We will apply the cardiospec 1000 unit for LI-ESWL in the penile and inguinal areas, 300 shocks per area, total of 1500 shocks. Full description of treatment series can be seen in the detailed protocol.
Sponsors & Collaborators
-
Rambam Health Care Campus
lead OTHER
Principal Investigators
-
Ilan Gruenwald, MD · Rambam Health Care Campus
-
Yoram Vardi, Prof. MD · Rambam Health Care Campus
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-07-31
- Primary Completion
- 2014-07-31
- Completion
- 2015-01-31
Countries
- Israel
Study Locations
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