Photonic Needle and intraforaminal epidurale injection (sleeve) - observational study in humans (Sleeve 1 study)
Completed
- Conditions
- nerve painradicular pain10041543
- Registration Number
- NL-OMON35392
- Lead Sponsor
- Philips
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 33
Inclusion Criteria
- Radicular pain
- Patients* age is 18-80 years
- Signed informed consent
Exclusion Criteria
- Pregnancy
- Photodynamic therapy used before
- Inability to give informed consent
- Contrast fluid allergy
- Any operation on the spine at the side of intervention
- Coagulation disorders / disturbance
- Infections at the level of intervention
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to investigate the potential of the<br /><br>photonic needle to discriminate between correct and incorrect placement of the<br /><br>needle tip in the target area of the procedure (M4 - tissue), as confirmed by<br /><br>contrast-enhanced fluoroscopy.<br /><br><br /><br>The main study parameters are:<br /><br>1) Successfully acquired diffuse reflectance spectra obtained at measurement<br /><br>point M4: midforaminal, halfway the foramen (the target treatment location) as<br /><br>encountered during image-guided intraforaminal injections on lumbar level.<br /><br>2) Confirmation of target area with fluoroscopy and injection of contrast fluid<br /><br>(gold standard).<br /><br>3) *Certainty score* on a 3-point scale (1 = uncertain, 2 = certain, 3 = very<br /><br>certain) will be provided by the physician. The type of tissue present at the<br /><br>needle tip will be based on the information available from imaging.</p><br>
- Secondary Outcome Measures
Name Time Method