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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03581279
Other study ID # PRO-000879
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 8, 2018
Est. completion date October 31, 2019

Study information

Verified date January 2022
Source T2 Biosystems
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The T2Lyme assay will be compared to Borrelia culture from erythema migrans (EM) biopsy and/or detection of the C6 antigen in serum collected prospectively from patients suspected of early Lyme disease.


Description:

The objective of this study is to demonstrate the clinical performance of the T2Lyme Panel on the T2Dx instrument. The assay will be compared to Borrelia culture from erythema migrans (EM) biopsy and/or detection of the C6 antigen in serum collected prospectively from patients suspected of early Lyme disease. The data from this study will be used to support a de novo application for the T2Lyme Panel to the U.S. Food and Drug Administration (FDA) for product approval. The T2Lyme Panel is an investigational use in vitro diagnostic (IVD) designed to qualitatively detect and identify the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as an inclusive Borrelia spp. detection channel) from K2EDTA human whole blood samples.


Recruitment information / eligibility

Status Terminated
Enrollment 18
Est. completion date October 31, 2019
Est. primary completion date October 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Presence of erythematous skin lesion, consistent with erythema migrans (EM). - Age 18 or older. - Ability to read, comprehend, and sign the informed consent form. - Two (2) or more signs/symptoms of Lyme Disease Exclusion Criteria: - Subject has medically diagnosed bleeding disorder. - Having had taken antibiotics in the past 30 days. - EM located on face or neck. - Unable to provide consent.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
T2Lyme Panel testing
The T2Lyme Panel is an investigational use in vitro diagnostic (IVD) designed to qualitatively detect and identify the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as an inclusive Borrelia spp. detection channel) from K2EDTA human whole blood samples.

Locations

Country Name City State
United States Gundersen Health System La Crosse Wisconsin
United States South County Internal Medicine Wakefield Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
T2 Biosystems

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Lyme Disease Detected in Human Whole Blood Samples Qualitative detection of genetic material (DNA) from the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as inclusive Borrelia spp.) from K2EDTA human whole blood samples using the T2Dx instrument and T2Lyme reagents. 1 day
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