Wakefield, Rhode Island 02879

  • Lyme Disease

Purpose:

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.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

PRO-000879


NCT ID:

NCT03581279


Secondary ID:


Study Acronym:


Brief Title:

Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel


Official Title:

Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

T2 Biosystems


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Actual


Study Dates

Start Date:May 8, 2018
Completion Date:October 31, 2019
Completion Type:Actual
Primary Completion Date:October 31, 2019
Primary Completion Type:Actual
Verification Date:January 2020
Last Changed Date:January 27, 2020
First Received Date:June 26, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Detection of Lyme Disease in human whole blood samples
Time Frame:1 day
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Device
Name:T2Lyme Panel testing
Description: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.
Arm Name:EM present

Study Arms

Study Arm Type:Active Comparator
Arm Name:No EM present
Description:All patients must display signs/symptoms of Lyme disease but do not have an EM lesion.
Study Arm Type:Active Comparator
Arm Name:EM present
Description:All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:T2 Biosystems

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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