Last reviewed · How we verify
INJ-INAR-01 Use of BIP-Needles in Rheumatologic Injections
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.
Details
| Lead sponsor | Injeq Ltd |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 79 |
| Start date | 2014-10 |
| Completion | 2016-01 |
Conditions
- Intra-articular Injections
Interventions
- Injeq Bioimpedance Probe (BIP) Needle
Primary outcomes
- True Positive Detection of Synovial Fluid Marked in Case Report Form — During intra-articular injection
Measurement device indicates with a sound and visual feedback when needle is in contact with synovial fluid. Physician verifies the location with ultrasound imaging, aspiration of synovial fluid and/or lack of resistance in glucocorticoid injection. Even if the device does not detect the synovial fluid, physician performs the injection when needed. Physician marks to the case report form whether the device provided detections during the puncture and were the detections true or false detections.
Countries
Finland