Photonic Needle and Sleeve Study (PhotonicNeedle)

This study has been completed.
Sponsor:
Collaborator:
Philips Healthcare
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01476709
First received: November 17, 2011
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

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
Puncture; Instrument
Pain

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Photonic Needle and Intraforaminal Epidural Injection (Sleeve) - Observational Study in Humans

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Statistical analysis of the difference between diffuse reflectance spectra obtained for correct and incorrect needle placement in the target area of the procedure. [ Time Frame: direct measurement ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: direct measurement ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who have radicular pain on lumbar level, caused by disc herniation, and/or lateral recessus stenosis and/or radiculopathy eci.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476709

Locations
Netherlands
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
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01476709     History of Changes
Other Study ID Numbers: MEC 11-1-005
Study First Received: November 17, 2011
Last Updated: April 5, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Puncture; Instrument
Optics and Photonics
Pain

ClinicalTrials.gov processed this record on September 29, 2014