Erectile Dysfunction (ED)FMSNCT03651024
Sano V First In Human Study to Treat ED
A study testing ED surgery in people with Erectile Dysfunction (ED), run by Sano V Pte Ltd.
Trial summary
A Prospective, First in Human Study to Evaluate the Safety and Performance of a Flow Modification System Read more about this study
- Who is it for?
- Ages 25 to 60 years, men only
- Conditions the study is for
- Erectile Dysfunction (ED)
- What is being tested?
- ED surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patient understands and has signed the study informed consent form.
- Documented history of erectile dysfunction
- Sexually active
Who cannot join
- 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
About this study
Official title: A Prospective, First in Human Study to Evaluate the Safety and Performance of a Flow Modification System
A Prospective, First in Human Study to Evaluate the Safety and Performance of a Flow Modification System
- Conditions
- Erectile Dysfunction (ED)
- Being tested
- ED surgery
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED surgeryDevice
The surgical implant for ED treatment
| Study group | Role | What they receive |
|---|---|---|
| Treating Patients with ED | Other | Treatment of patients with ED Receives: Device: ED surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The surgical implant for ED treatment
Primary Safety Endpoint
- 30-day Freedom from Major Adverse Events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study startOct 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction (ED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sano V Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651024
- Sponsor's protocol ID
- CLN0001
- Acronym
- FMS
- Status last verified
- Aug 2018
- First submitted
- 27 Aug 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, First in Human Study to Evaluate the Safety and Performance of a Flow Modification System
- ClinicalTrials.gov ID
- NCT03651024
- Acronym / sponsor ID
- FMS / CLN0001
- Conditions
- Erectile Dysfunction (ED)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sano V Pte LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Prospective, First in Human Study to Evaluate the Safety and Performance of a Flow Modification System
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treating Patients with ED | Other | Device: ED surgeryTreatment of patients with ED |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient understands and has signed the study informed consent form.
- Documented history of erectile dysfunction
- Sexually active
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ED surgeryThe surgical implant for ED treatment | Device | Treating Patients with ED |
Primary outcome
The surgical implant for ED treatment
Time frame: 12 months
Primary Safety Endpoint • 30-day Freedom from Major Adverse Events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ED surgery in people with Erectile Dysfunction (ED), run by Sano V Pte Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The surgical implant for ED treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.