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NGS

DNA Sequencing vs Culture Testing for Infected Penile Implants

N/A
Waitlist Available
Research Sponsored by MicroGenDX
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 1 of the following: Device part stuck to thinning skin, any drainage from the wound site, massive red and swollen genitalia parts, exposed penile prosthesis parts, draining open tract, draining hematoma
Within 6 months of penile prosthesis surgery
Must not have
Less than 18 or more than 80 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the effectiveness of next generation sequencing (NGS) versus standard culture for identifying microbes in clinically infected penile implants.

Who is the study for?
Men aged 18-80 who had penile prosthesis surgery within the last 6 months and are showing signs of infection like drainage, swelling, or exposed implant parts. It's not for those under 18 or over 80, with communication issues, non-compliance, active addiction, or if pain is their main concern.
What is being tested?
This study compares traditional culture methods to next-generation DNA sequencing (NGS) in identifying infections in clinically infected penile implants to see which method affects patient outcomes better.
What are the potential side effects?
Since this trial involves diagnostic methods rather than medications or invasive treatments, there are no direct side effects from the interventions being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have complications from a device, including skin issues or drainage.
Select...
I had penile prosthesis surgery within the last 6 months.
Select...
I have a penile prosthesis.
Select...
I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am either younger than 18 or older than 80.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Device survival rates by calculating by incidence of implant freely mobile and working without tenderness
Patient satisfaction of penile prosthesis

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group B - NGSExperimental Treatment1 Intervention
Treatment will be based on NGS results reviewed by an infectious disease doctor
Group II: Group A - CultureActive Control1 Intervention
Following local standard of care, treatment will be based on standard culture

Find a Location

Who is running the clinical trial?

MicroGenDXLead Sponsor
2 Previous Clinical Trials
135 Total Patients Enrolled

Media Library

Next-Generation DNA Sequencing (NGS) Clinical Trial Eligibility Overview. Trial Name: NCT05287438 — N/A
Infections Research Study Groups: Group B - NGS, Group A - Culture
Infections Clinical Trial 2023: Next-Generation DNA Sequencing Highlights & Side Effects. Trial Name: NCT05287438 — N/A
Next-Generation DNA Sequencing (NGS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05287438 — N/A
~10 spots leftby Dec 2025
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