Sano V First In Human Study to Treat ED (FMS)

Sano V

Status: Unknown

Conditions: Erectile Dysfunction (ED)

Treatments: Device: ED surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT03651024

CLN0001

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: Male

Ages: 25 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treating Patients with ED

Other group

Description:

Treatment of patients with ED

Treatment:

Device: ED surgery