NCT03651024

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

August 27, 2018

Last Update Submit

August 27, 2018

Conditions

Erectile Dysfunction (ED)

Outcome Measures

Primary Outcomes (1)

  • The surgical implant for ED treatment

    Primary Safety Endpoint • 30-day Freedom from Major Adverse Events

    12 months

Study Arms (1)

Treating Patients with ED

OTHER

Treatment of patients with ED

Device: ED surgery

Interventions

ED surgeryDEVICE

The surgical implant for ED treatment

Treating Patients with ED

Eligibility Criteria

Age25 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient understands and has signed the study informed consent form.
  • Documented history of erectile dysfunction
  • Sexually active

You may not qualify if:

  • \- 1. Current participation in any clinical study with any investigational drug or device.
  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2018

First Posted

August 29, 2018

Study Start

October 1, 2018

Primary Completion

December 1, 2018

Study Completion

October 1, 2019

Last Updated

August 29, 2018

Record last verified: 2018-08