MedTrace Logo

Photonic Needle and Sleeve Study

NCT01476709 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2012-04-06

No results posted yet for this study

Summary

Rationale: evaluate the potential of the photonic needle (photonic needle technology) to discriminate tissues that are relevant to recognize during intraforaminal (transforaminal) epidural injection on lumbar level.

Objective: The primary objective of this study is to investigate the potential of the photonic needle to discriminate between correct and incorrect placement of the needle tip in the target area of the procedure (M4 - tissue), as confirmed by contrast-enhanced fluoroscopy. The secondary objectives are to investigate the differences in the optical signals obtained with the photonic needle at a set of different pre-defined positions (M1, M2 and M3) encountered along the needle trajectory during above-mentioned procedures, and to detect potential intravascular positioning of the needle-tip at the target point (M4 - blood), Study design: this is a single blind observational study. Study population: Patients who have radicular pain on lumbar level, for example caused by disc herniation, and/or lateral recessus stenosis and/or radiculopathy eci.

Main study parameters/endpoints: The main study parameters are: 1) successfully acquired diffuse reflectance spectra obtained at measurement point M4: midforaminal, halfway the foramen (the target treatment location) as encountered during image-guided intraforaminal injections on lumbar level, 2) confirmation of target area with fluoroscopy and injection of contrast fluid (gold standard), 3) "Certainty score" on a 3-point scale (1 = uncertain, 2 = certain, 3 = very certain) will be provided by the physician. The type of tissue present at the needle tip will be based on the information available from imaging .

The secondary study parameters are: 1) successfully acquired diffuse reflectance spectra obtained at measurement points M1-M3: M1 in muscle, M2 extra-foraminal, M3 foraminal at a distance 1/3 of the diameter of the foramen from the entrance of the foramen, as encountered during image-guided intraforaminal injections on lumbar level, 2) successfully acquired diffuse reflectance spectra obtained at measurement point M4, in case of a vascular puncture (M4-blood), 3) confirmation images by ultrasound imaging at location M1 as described above, 4) confirmation images by fluoroscopy at locations M2 and M3, 5) digital subtraction angiography images after contrast injection at location M4, confirming vascular penetration (gold standard for vessel puncture), 6) "Certainty score" on a 3-point scale (1 = uncertain, 2 = certain, 3 = very certain) provided by the physician for assignment of the type of tissue present at the needle tip, based on the information available from imaging at M1 and at M4.

Conditions

  • Puncture; Instrument
  • Pain

Sponsors & Collaborators

  • Philips Healthcare

    collaborator INDUSTRY

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Maarten van Kleef, prof. Dr. · Maastricht University Medical Centre

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01476709 on ClinicalTrials.gov