Trials / Completed
CompletedNCT06112301
Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 250 (actual)
- Sponsor
- Invivoscribe, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This protocol describes the pivotal accuracy study for the IdentiClone Dx IGH (IC IGH Dx) Assay. The intent of the accuracy study is to demonstrate agreement between the results of the IC IGH Dx Assay and a predicate devise or assay on retrospective and residual de-identified DNA extracted from peripheral blood (PB) samples from individuals with suspected B-Cell Lymphoproliferations. The predicate device will be the LymphoTrack Dx IGH (FR1/FR2/FR3) Assays - MiSeq (LT Dx IGH-CE-IVD), which is a CE-IVD assay with a similar intended use as the IC IGH Assay on the same sample type.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | IdentiClone Dx IGH (IC IGH Dx) Assay | The IdentiClone Dx IGH Assay is an in vitro diagnostic product intended for qualitative, capillary electrophoresis based-detection of clonality in immunoglobulin heavy chain gene rearrangements (IGH) in peripheral blood specimens as an adjunctive method for the diagnosis of B-cell lymphoproliferative disease |
Timeline
- Start date
- 2024-01-02
- Primary completion
- 2024-11-06
- Completion
- 2024-11-06
- First posted
- 2023-11-01
- Last updated
- 2024-12-04
Locations
3 sites across 3 countries: United States, Germany, Japan
Source: ClinicalTrials.gov record NCT06112301. Inclusion in this directory is not an endorsement.