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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental |
| |
| Sham | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VERTICA Active device | Device | VERTICA device with a therapeutic RF energy level |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The IIEF-EF total score ranges between 6 to 30. A higher total score indicates relatively better erectile functioning. | 12 weeks |
| 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. | The IIEF-EF total score ranges between 6 to 30. A higher total score indicates relatively better erectile functioning. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahava Stein | Contact | 1-888-443-3867 | ahava@asteinrac.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine Medical Center | Recruiting | Newport Beach | California | 92660 | United States |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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Active vs. Sham
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Study personnel, including the investigator and raters and study subjects will be blinded to the treatment assignment (active vs. sham)
| VERTICA Sham device |
| Device |
VERTICA device with a low, non-therapeutic RF energy level |
|
| San Diego Sexual Medicine | Recruiting | San Diego | California | 92120 | United States |
|
| Optimal Health Miami | Recruiting | Aventura | Florida | 33180 | United States |
|
| The University of Chicago | Withdrawn | Chicago | Illinois | 60637 | United States |
| Rachel Rubin MD | Recruiting | Bethesda | Maryland | 20814 | United States |
|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
|
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |