Intra-articular Injections
Conditions
Keywords
Arthritis, Bioimpedance, Glucocorticoid, Intra-articular injection, Needle Guidance
Brief 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.
Detailed description
Clinical device investigation
Interventions
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.
Sponsors
Injeq Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult patients having an inflammatory rheumatic disease requiring an intra-articular glucocorticoid injection.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
Participant flow
Recruitment details
First punctures were utilized for tissue detection model validation and tuning. In pivotal phase, the model kept unchanged. Performance of the device was evaluated from pivotal phase results.
Participants by arm
| Arm | Count |
|---|---|
| BIP Needle 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.
Injeq Bioimpedance Probe (BIP) Needle: 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. | 79 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 5 |
| Overall Study | Model tuning phase | 28 |
Baseline characteristics
| Characteristic | BIP Needle |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 21 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants |
| Age, Continuous | 51 years |
| Sex: Female, Male Female | 63 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 79 |
| serious Total, serious adverse events | 0 / 79 |
Outcome results
Primary
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.
Time frame: During intra-articular injection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIP Needle | True Positive Detection of Synovial Fluid Marked in Case Report Form | 86 percentage of injected joints |