Use of BIP-Needles in Rheumatologic Injections

Study Overview
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Brief Summary
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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.

Detailed Description
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Clinical device investigation

Official Title
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INJ-INAR-01 Use of BIP-Needles in Rheumatologic Injections

Conditions
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Intra-articular Injections

Intervention / Treatment
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* Device: Injeq Bioimpedance Probe (BIP) Needle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIP Needle<br>Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It measures bioimpedance and detects synovial fluid during inta-articular injection. | Device: Injeq Bioimpedance Probe (BIP) Needle<br>* Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with synovial fluid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| True Positive Detection of Synovial Fluid Marked in Case Report Form | 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. | During intra-articular injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthritis, Bioimpedance, Glucocorticoid, Intra-articular injection, Needle Guidance