Back to resultsSano V First In Human Study to Treat ED (FMS)
Primary Purpose
Erectile Dysfunction (ED)
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ED surgery
Sponsored by
About this trial
This is an interventional device feasibility trial for Erectile Dysfunction (ED)
Eligibility Criteria
Inclusion Criteria:
- Patient understands and has signed the study informed consent form.
- Documented history of erectile dysfunction
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treating Patients with ED
Arm Description
Treatment of patients with ED
Outcomes
Primary Outcome Measures
The surgical implant for ED treatment
Primary Safety Endpoint
• 30-day Freedom from Major Adverse Events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03651024
Brief Title
Sano V First In Human Study to Treat ED
Acronym
FMS
Official Title
A Prospective, First in Human Study to Evaluate the Safety and Performance of a Flow Modification System
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2018 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sano V Pte Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Prospective, First in Human Study to Evaluate the Safety and Performance of a Flow Modification System
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction (ED)
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treating Patients with ED
Arm Type
Other
Arm Description
Treatment of patients with ED
Intervention Type
Device
Intervention Name(s)
ED surgery
Intervention Description
The surgical implant for ED treatment
Primary Outcome Measure Information:
Title
The surgical implant for ED treatment
Description
Primary Safety Endpoint
• 30-day Freedom from Major Adverse Events
Time Frame
12 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient understands and has signed the study informed consent form.
Documented history of erectile dysfunction
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
12. IPD Sharing Statement
Learn more about this trial
Sano V First In Human Study to Treat ED
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