N/A
N=79
Use of BIP-Needles in Rheumatologic Injections
Intra-articular Injections
Bottom Line
View on ClinicalTrials.gov: NCT02605928 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: True Positive Detection of Synovial Fluid Marked in Case Report Form — 86 percentage of injected joints
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Injeq Bioimpedance Probe (BIP) Needle (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Injeq Ltd
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY True Positive Detection of Synovial Fluid Marked in Case Report Form |
86 | — |
Summary
The study focuses on needle guidance in rheumatologic operations - glucocorticoid injections inside joint capsules specifically. The main purpose of the study is to assess and validate the clinical feasibility and performance of Bioimpedance Probe (BIP) Needles and assess the benefits, drawbacks and risks related to use of the BIP Needles.
Eligibility Criteria
Inclusion Criteria
- Adult patients having an inflammatory rheumatic disease requiring an intra-articular glucocorticoid injection.
Exclusion Criteria
- Exclusion criteria are the same as generally for intra-articular glucocorticoid injections (e.g. bacterial infection or recent surgical operation relating the joint).
- In addition for not giving (or not capable to give) the consent personally for any reason is an absolute exclusion criterion.
- In addition pregnant women are excluded
Data sourced from ClinicalTrials.gov (NCT02605928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.