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Assessment of Urinary Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) Technology in the Evaluation and Management of Females With Chronic Bladder Pain and Cystitis-like Symptoms

NCT05276466 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-03-15

No results posted yet for this study

Summary

Real-world clinical practice multicenter study to determine the clinical implications of employing PCR/NGS technology to identify and treat potential urinary pathogens in female participants identified with bladder pain and/or cystitis-like symptoms.

Conditions

  • Interstitial Cystitis
  • Bladder Pain Syndrome

Interventions

DIAGNOSTIC_TEST

Polymerase Chain Reaction and Next-Generation DNA Sequencing

The qPCR Rapid Screening Panel is a quantitative real-time PCR test for bacteria and fungi. Next-Generation DNA Sequencing is the Comprehensive Sequencing test will detect virtually all microbial organisms and fungal pathogens that may be present in patient specimens.

Sponsors & Collaborators

  • MicroGenDX

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-11-15
Completion
2023-12-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05276466 on ClinicalTrials.gov