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NCT01292486 · ClinicalTrials.gov registry record · NA
Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure
A NA study, sponsored by Terumo BCT.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT01292486: Completed NA study, sponsored by Terumo BCT.
NCT01292486 is a NA study that has completed, run by Terumo BCT. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01292486, a NA study, has completed, sponsored by Terumo BCT.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of this investigation is to establish that hematopoetic stem cells collected on a new centrifugal blood separator, CaridianBCT's Spectra Optia Apheresis System, are able to reconstitute the hematopoetic systems of patients treated with myeloablative therapy, equivalent to hematopoetic cells harvested on the predicate COBE® Spectra platform.
Primary Outcome
Neutrophil recovery is defined as the day on which the peripheral blood absolute neutrophil count exceeds 500/μL (ANC500)for the first of three consecutive measurements obtained on different days following transplant of peripheral blood stem cells in patients treated with myeloablative therapy for their underlying disease. As this was a test of non-inferiority, the null hypothesis to be tested (H0) was that the difference between the observed day to neutrophil recovery and the historical median
Interventions
- DEVICE Spectra Optia Apheresis System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2011-02 |
| Est. Completion | 2011-12 |
| Phase | NA |
What the finished NCT01292486 record still lists
NCT01292486 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Spectra Optia Apheresis System is the first listed.
NCT01292486 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01292486 about?
NCT01292486 is a clinical study titled "Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure". The purpose of this investigation is to establish that hematopoetic stem cells collected on a new centrifugal blood separator, CaridianBCT's Spectra Optia Apheresis System, are able to reconstitute the hematopoetic systems of patients treated with myeloablative therapy, equivalent to hematopoetic ce...
What is the current status of trial NCT01292486?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2011-02. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01292486?
The interventions under investigation include: Spectra Optia Apheresis System (DEVICE).
Who is sponsoring clinical trial NCT01292486?
This trial is sponsored by Terumo BCT, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01292486's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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