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Optical Tissue Stylet Observational Study in Humans.


- candidate number8115
- NTR NumberNTR2359
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jun-2010
- Secondary IDsNL31578.068.10 / 09-1-075 ; CCMO / METC AZM
- Public TitleOptical Tissue Stylet Observational Study in Humans.
- Scientific TitleOptical Tissue Stylet Observational Study in Humans.
- ACRONYM
- hypothesisThe aim of this study is to investigate whether the optical tissue stylet technology can discriminate tissues that are relevant for interventional pain procedures.
- Healt Condition(s) or Problem(s) studiedInterventional pain management
- Inclusion criteria1. More than 18 years old;
2. Patients visiting the AZM department of anesthesiology, and fall into one of the following classes:
A. Neuralgia paraesthetica patients for whom the indication of a blockade of the nervus cutaneus femoris lateralis has been made;
B. Patients experiencing pain in the groin area, for whom the indication of a blockade of the nervus ilioinguinalis, nervus iliohypogastricus, or nervus genitofemoralis has been made;
C. Patients experiencing discogenic lower back pain, which have been indicated for a blockade of the communicating ramus;
D. Patients who have been indicated for a sympathetic blockade either because of a complex regional pain syndrome, or because of a peripheral vascular disease.
- Exclusion criteria1. Pregnancy;
2. Photodynamic therapy;
3. Inability to give informed consent.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 11-jun-2010
- planned closingdate31-aug-2010
- Target number of participants35
- InterventionsA smart stylet is used to collect optical data during the normal interventional pain procedures. There is no extra intervention on the patient in addition to the normal treatment procedures.
- Primary outcomeThis is an observational study. No outcome is measured.
- Secondary outcomeThis is an observational study. No outcome is measured.
- TimepointsMeasurements are made during the procedures. No follow-up is required for this study.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Stefan Roggeveen
- CONTACT for SCIENTIFIC QUERIESProf. Maarten Kleef, van
- Sponsor/Initiator University Hospital Maastricht (AZM)
- Funding
(Source(s) of Monetary or Material Support)
Philips Research
- PublicationsN/A
- Brief summaryThe primary objective of this study is to explore differences in the optical signals obtained in tissues encountered during interventional pain procedures. The study takes place at University Hospital Maastricht (AZM). Patients are recruited in the Netherlands.
- Main changes (audit trail)
- RECORD3-jun-2010 - 3-dec-2012


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