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NCT00567541 · ClinicalTrials.gov registry record · Phase 2
An Implantable Microneuromodulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Stroke Subjects
A Phase 2 study, sponsored by Bioness.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT00567541 is a Phase 2 study that has completed, run by Bioness. The registered enrollment target is 16 participants.
The verdict
NCT00567541, a Phase 2 study, has completed, sponsored by Bioness.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
The goal of this research study is to investigate safety and gather initial effectiveness data for a new implanted device designed to treat chronic shoulder pain in chronic post-stroke subjects. The BBPM weighs less than 0.03 ounces and measures 1" x 0.1". It is implanted into the shoulder to stimulate the axillary nerve. Stimulation of this nerve may reduce shoulder pain, reduce shoulder subluxation, improve motion, improve function, and possibly decrease use of pain medication. CAUTION--Investigational device. Limited by Federal law to investigational use.
Interventions
- DEVICE Battery Powered Microneuromodulator (BBPM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2007-06 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00567541
The ClinicalTrials.gov registry entry for NCT00567541 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bioness, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Battery Powered Microneuromodulator (BBPM) is the first listed.
NCT00567541 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00567541 about?
NCT00567541 is a clinical study titled "An Implantable Microneuromodulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Stroke Subjects". The goal of this research study is to investigate safety and gather initial effectiveness data for a new implanted device designed to treat chronic shoulder pain in chronic post-stroke subjects. The BBPM weighs less than 0.03 ounces and measures 1" x 0.1". It is implanted into the shoulder to stimul...
What is the current status of trial NCT00567541?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2007-06. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00567541?
The interventions under investigation include: Battery Powered Microneuromodulator (BBPM) (DEVICE).
Who is sponsoring clinical trial NCT00567541?
This trial is sponsored by Bioness, which has 6 total clinical trials registered on ClinicalTrials.gov.
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