Status:
COMPLETED
Intrathecal Pump Refill Undergoing Regular Intrathecal Pump Refill
Lead Sponsor:
Dr med. Paolo Maino Viceprimario Anestesiologia
Collaborating Sponsors:
VU University of Amsterdam
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Brief Summary
Reservoir fill port identification by palpation versus ultrasound,a mono-centre prospective comparison study in patients undergoing regular intrathecal pump refill
Detailed Description
Intrathecal drug therapy with implantable intrathecal pumps is being utilized increasingly for the treatment of chronic refractory pain and spasticity. However, performing the regular refill procedure...
Eligibility Criteria
Inclusion
- 18 years or older at the time of enrollment;
- The patients are treated for chronic non-malignant pain or spasticity with an intrathecal
- programmable infusion pump and undergo regular refills of their pumps in our clinic.
- Able to provide adequate given written, informed consent to participate in this study.
Exclusion
- patient refusal to participate or provide informed consent standard exclusions; pregnancy, lactation, treatment with other investigational products.
- other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction,
- cardiovascular disease).
- infection at the puncture site -participation in another study.-
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT02296515
Start Date
October 1 2014
End Date
November 1 2017
Last Update
January 3 2018
Active Locations (1)
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1
Centro del Dolore, Neurocentro, Opedale Regionale di Lugano
Lugano, Canton Ticino, Switzerland, 6900