Trial Outcomes & Findings for Use of BIP-Needles in Rheumatologic Injections (NCT NCT02605928)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

79 participants

Primary outcome timeframe

During intra-articular injection

Results posted on

2017-04-04

Participant Flow

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.

Unit of analysis: Injected joints

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	79 132
Overall Study Pivotal Phase, Statistical Phase	51 80
Overall Study COMPLETED	46 72
Overall Study NOT COMPLETED	33 60

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Model tuning phase	28
Overall Study Lack of Efficacy	5

Baseline Characteristics

Use of BIP-Needles in Rheumatologic Injections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BIP Needle n=79 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	58 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants
Age, Continuous	51 years n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BIP Needle n=72 Injected joints 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.
True Positive Detection of Synovial Fluid Marked in Case Report Form	86 percentage of injected joints Interval 75.0 to 93.0

Adverse Events

BIP Needle

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BIP Needle n=79 participants at risk 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.
Injury, poisoning and procedural complications Painful intra-articular injection	2.5% 2/79 • Number of events 2

Additional Information

PhD MD Ritva Peltomaa

Department of Medicine, Division of Rheumatology, Helsinki University Central Hospital and University of Helsinki, Finland

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place