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…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 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.
Secondary outcome
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).
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-blood.
Background summary
For effective interventional pain treatments, correct needle placement is
crucial. Therefor, currently, needle placement is done under image-guidance,
and the actual treatment location is confirmed with electrical stimulation
before the treatment takes place. However, accuracy of needle placement could
still be improved if information would be available that would complement the
current imaging and electrical stimulation methods. We have developed a system
based on optical spectroscopy that has the potential to provide such
complementary information.
This study will be an observational study in a limited number of patients.
Special sterile optical tissue stylets have been made, that fit into the lumen
of the needles that are normally used for treatment. A set of image-guided
interventional pain procedures has been selected, during which diffuse
reflectance spectra will be acquired with the optical tissue stylets, at a
number of points along the needle trajectory that allow for confirmation by
imaging and/or electrical stimulation.
We will investigate whether the optical tissue stylet technology provides
information relevant for identifying specific tissue transitions. The
procedures during which data will be obtained are currently common clinical
practice. This study will not increasethe number of interventional pain
procedures performed or the number of patients undergoing a certain procedure,
since subjects will be included who have been scheduled to undergo the selected
procedure irrespective of the study. During the observational study, data
collected by the system will not be provided to the physician during the
procedures, as we intend to influence the course of the procedure as little as
possible.
Study 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.
Study design
This study will be a single blinded observational study in a limited number of
patients.
Study burden and risks
In order to collect the data during the treatments, the treatments will take a
bit longer than normal. The expected maximum procedure lengthening is 20% of
normal procedure duration, up to a maximum of 5 minutes, which is clinically
acceptable. Subjects who participate in the study will not benefit from the
test nor be exposed to additional risks. They will experience minimal
discomfort. In future, the results of this investigation may assist the
improvement of interventional pain procedures.
High Tech Campus 34
5656 AE
NL
High Tech Campus 34
5656 AE
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL37470.068.11 |