Sano V First In Human Study to Treat ED

Erectile Dysfunction (ED) Clinical Trial

— FMS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03651024
• Other study ID #: CLN0001
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2018
• Est. completion date: October 2019

Study information

• Verified date: August 2018
• Source: Sano V Pte Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: October 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Erectile Dysfunction (ED)

Intervention

Device:
• ED surgery
The surgical implant for ED treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sano V Pte Ltd

Outcome

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