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NCT00871975 · ClinicalTrials.gov registry record · Phase 4
Tetra-NIRS Clinical Study
A Phase 4 study, sponsored by Laborie Medical Technologies.
- Terminated
- Registry status
- Phase 4
- Development phase
- 155
- Enrollment target
NCT00871975: Clinical Trial Phase 4 study, sponsored by Laborie Medical Technologies.
NCT00871975 is a Phase 4 study that was terminated before completion, run by Laborie Medical Technologies. The registered enrollment target is 155 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00871975, a Phase 4 study, was terminated before completion, sponsored by Laborie Medical Technologies.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 155 participants
- Enrollment target
Study Summary
The purpose of this evaluation is to validate the previous clinical study results using a Near-Infrared Spectroscopy (NIRS) device, as compared to the conventional urodynamics (UDS) testing. The experiment will use the commercially available Tetra-NIRS and Laborie UDS equipment. The hypothesis is that the Tetra-NIRS device, in the clinical environment, provides data to enhance the analysis using the standard urodynamics equipment (stand-alone Urodynamic procedure).
Primary Outcome
The Tetra-NIRS device provides a linear pattern similar to the pressures obtained during urodynamics. The NIRS output shows relative change in hemoglobin concentrations (oxygenated and deoxygenated) where the numerical value does not actually indicate the concentration, so there is no unit of measure. The numerical output is used to track change over time, or trendline analysis. A qualified interpreter studied tracings for significant changes (+/-2 Hb units) in the NIRS patterning during detruso
Interventions
- DEVICE Urodynamics + TETRA - NIRS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2009-04 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
Why NCT00871975 stopped before completion
NCT00871975 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Urodynamics + TETRA - NIRS is the first listed.
NCT00871975 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00871975 about?
NCT00871975 is a clinical study titled "Tetra-NIRS Clinical Study". The purpose of this evaluation is to validate the previous clinical study results using a Near-Infrared Spectroscopy (NIRS) device, as compared to the conventional urodynamics (UDS) testing. The experiment will use the commercially available Tetra-NIRS and Laborie UDS equipment. The hypothesis is t...
What is the current status of trial NCT00871975?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 155 participants. The study started on 2009-04. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00871975?
The interventions under investigation include: Urodynamics + TETRA - NIRS (DEVICE).
Who is sponsoring clinical trial NCT00871975?
This trial is sponsored by Laborie Medical Technologies, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00871975's enrollment target sits among peer trials
155 525th of 2000 higher than 1,473 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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