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PhotonicNeedle: Photonic Needle and Sleeve Study

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01476709
Collaborator
Philips Healthcare (Industry)
30
Enrollment
1
Location
4
Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Time Perspective:
    Prospective
    Official Title:
    Photonic Needle and Intraforaminal Epidural Injection (Sleeve) - Observational Study in Humans
    Study Start Date :
    Nov 1, 2011
    Actual Primary Completion Date :
    Mar 1, 2012
    Actual Study Completion Date :
    Mar 1, 2012

    Outcome Measures

    Primary Outcome Measures

    1. Statistical analysis of the difference between diffuse reflectance spectra obtained for correct and incorrect needle placement in the target area of the procedure. [direct measurement]

    Secondary Outcome Measures

    1. Statistical analysis of differences between diffuse reflectance spectra obtained in muscle, extra-foraminal, foraminal at a distance 1/3 of the diameter of the foramen from the entrance of the foramen,intravascular. [direct measurement]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Scheduled for regular treatment: intraforaminal epidural injection

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maastricht University Medical Center Maastricht Limburg Netherlands

    Sponsors and Collaborators

    • Maastricht University Medical Center
    • Philips Healthcare

    Investigators

    • Principal Investigator: Maarten van Kleef, prof. Dr., Maastricht University Medical Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maastricht University Medical Center
    ClinicalTrials.gov Identifier:
    NCT01476709
    Other Study ID Numbers:
    • MEC 11-1-005
    First Posted:
    Nov 22, 2011
    Last Update Posted:
    Apr 6, 2012
    Last Verified:
    Apr 1, 2012
    Keywords provided by Maastricht University Medical Center
    Puncture; Instrument
    Optics and Photonics
    Pain

    Study Results

    No Results Posted as of Apr 6, 2012