Status:
WITHDRAWN
Low Intensity Linear Shockwave Therapy for Erectile Dysfunction
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
DIREX SYSTEMS CORPORATION
Conditions:
Vasculogenic Erectile Dysfunction
Eligibility:
MALE
40-80 years
Phase:
NA
Brief Summary
MoreNovaED is a Linear Shockwaves (LISW) device in which shockwaves are focused onto line segments for improved organ coverage. Shockwaves produced by MoreNovaED are aimed at the left and right corpor...
Detailed Description
Morenova-Erectile dysfunction (ED) is a Linear Shockwaves (LISW) device which incorporates a unique shockwave transducer operable to deliver shockwaves to a treated region confined to a narrow rectang...
Eligibility Criteria
Inclusion
- The patient has been correctly informed about the study
- The patient must have given his informed and signed consent
- The patient is a man between 40 and 80 years of age
- The patient has ED of Vasculogenic origin
- The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
- The patient has been in a stable heterosexual relationship for over 3 months prior to enrollment
- A minimum of 2 sexual attempts per month for at least one month prior to enrollment
- The patient is suffering from erectile dysfunction lasting for over 6 months and not more than 5 years
- IIEF-EF score between 17 and 25
- Testosterone level 300-1000 ng/dL within 1 month prior to enrollment
- A1C level ≤ 7% within 1 month prior to enrollment
- Patients have at least a natural tumescence during sexual stimulation (EHS score ≥ 1).
Exclusion
- The patient is participating in another study that may interfere with the results or conclusions of this study
- Within the past three months, the patient has participated in another study that may interfere with the results or conclusions of this study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection
- The patient is an adult under guardianship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- History of radical prostatectomy or extensive pelvic surgery
- Venous leak
- Past radiation therapy of the pelvic region within 12 months prior to enrollment
- Recovering from cancer within 12 months prior to enrollment
- Neurological disease which effects erectile function
- Psychiatric disease which effects erectile function
- Anatomical malformation of the penis, including Peyronie's disease
- Testosterone level \<300 or \>1000 ng/dL within 1 month prior to enrollment
- A1C level \> 7% within 1 month prior to enrollment
- The patient is taking blood thinners and has an international normalized ratio \>3.
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03843086
Start Date
June 1 2019
End Date
March 1 2022
Last Update
May 25 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.