MedTrace Logo

Self Sampling for Rapid Turnaround Testing in the Emergency Department

NCT03676816 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 533

Last updated 2021-08-05

No results posted yet for this study

Summary

Consenting adult female patient felt by the provider to require gonorrhea/chlamydia endocervical testing will be asked to provide an additional self sample specimen. The specimen will be sent to the laboratory using conventional diagnostic test for gonorrhea/chlamydia.

Conditions

  • Chlamydia Trachomatis
  • Neisseria Gonorrhoeae

Interventions

PROCEDURE

vaginal self sampling

This is a prospective, non-inferiority trial comparing two methods of collection using a US Food and Drug Administration- cleared 90-minute rapid nucleic acid amplification assay, the Xpert CT/NG assay. Any adult female patient admitted to the Emergency Department at Community Regional Medical Center felt by the provider to require gonorrhea/chlamydia endocervical testing may be entered in the study.

PROCEDURE

provider-performed endocervical sampling

provider-performed endocervical sampling is the gold standard for both gonorrhea and chlamydia. The provider takes a endocervical sample which will get sent to the laboratory as the standard care in comparison to the device being studied.

Sponsors & Collaborators

Principal Investigators

  • Brian Chinnock, MD · UCSF - Fresno

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-17
Primary Completion
2020-06-09
Completion
2020-06-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03676816 on ClinicalTrials.gov