Sano V First In Human Study to Treat ED

A Prospective, First in Human Study to Evaluate the Safety and Performance of a Flow Modification System

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03651024

Acronym

FMS

Enrollment

Registered

2018-08-29

Start date

2018-10-31

Completion date

2019-10-31

Last updated

2018-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction (ED)

Brief summary

A Prospective, First in Human Study to Evaluate the Safety and Performance of a Flow Modification System

Interventions

DEVICEED surgery

The surgical implant for ED treatment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

25 Years to 60 Years

Healthy volunteers

Inclusion criteria

1. Patient understands and has signed the study informed consent form. 2. Documented history of erectile dysfunction 3. Sexually active

Exclusion criteria

\- 1. Current participation in any clinical study with any investigational drug or device. 2\. Patient is known or suspected not to tolerate the procedure, including exposure to contrast 3. Active infection or fever that may be due to infection 4. Life expectancy \< 2 years due to other illnesses

Design outcomes

Primary

Measure	Time frame	Description
The surgical implant for ED treatment	12 months	Primary Safety Endpoint • 30-day Freedom from Major Adverse Events

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026