Sano V First In Human Study to Treat ED

NCT ID: NCT03651024

Last Updated: 2018-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2019-10-31

Brief Summary

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

Detailed Description

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Conditions

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Erectile Dysfunction (ED)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Treating Patients with ED

Treatment of patients with ED

Group Type OTHER

ED surgery

Intervention Type DEVICE

The surgical implant for ED treatment

Interventions

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ED surgery

The surgical implant for ED treatment

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sano V Pte Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CLN0001

Identifier Type: -

Identifier Source: org_study_id

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