Sano V First In Human Study to Treat ED

Not Applicable

• Conditions: Erectile Dysfunction (ED)
• Interventions: Device: ED surgery

• Registration Number: NCT03651024
• Lead Sponsor: Sano V Pte Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-27
• Study First Submitted QC: 2018-08-27
• Last Update Submitted: 2018-08-27
• Study First Posted: 2018-08-29
• Last Update Posted: 2018-08-29
• Study Start: 2018-10
• Primary Completion: 2018-12
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treating Patients with ED	ED surgery	Treatment of patients with ED

Primary Outcome Measures

Name	Time	Method
The surgical implant for ED treatment	12 months	Primary Safety Endpoint; • 30-day Freedom from Major Adverse Events