N/A
Completed N=47
Measuring Signatures in the Fluid Surrounding the Spinal Cord in Patients Who Have Problems With Intrathecal Drug Delivery
Source: ClinicalTrials.gov NCT01117090 ↗Enrolled (actual)
47
Serious AEs
29.8%
Results posted
Nov 2013
Primary outcomePrimary: Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis — 13; 16 Subjects whose CSF data agree with MD Dx
Summary
The purpose of this study is to record signatures from the fluid surrounding the spinal cord from people who have an implanted drug infusion system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis |
13; 16 | — |
| SECONDARY The Relationship Between Catheter Flow Resistance Check Data and Physician's Standard Trouble-shooting Diagnosis |
6.4; 19.9 | — |
| SECONDARY The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Cough |
21.0; 6.6 | — |
| SECONDARY The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Valsalva |
18.7; 4.8 | — |
Eligibility Criteria
Inclusion Criteria
- Be at least 12 years of age
- Have an implanted Medtronic drug infusion system for chronic intrathecal administration of drugs
- Report decreased therapeutic benefit, or show visible signs and/or symptoms of decreased therapeutic benefit
- Agree to undergo clinical tests designed to troubleshoot catheter-related problems or failure as a part of their normal standard of care
- Agree to provide signed informed consent.
Exclusion Criteria
- Are currently enrolled or plan to enroll in another investigational drug or device trial
- Have participated in an investigational drug or device study within 30 days of the in-clinic visit
- Whose health status would, in the opinion of the Clinical Investigator, be jeopardized by participation in the study
Data sourced from ClinicalTrials.gov (NCT01117090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.