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.

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Key information

Conditions

Intra-articular Injections Arthritis Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital, Clinic of Rheumathology

Helsinki, HUS, FI-00029, Finland

About this study

Clinical device investigation

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injeq Bioimpedance Probe (BIP) Needle

Device

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.

Primary outcomes

True Positive Detection of Synovial Fluid Marked in Case Report Form

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Injeq Ltd

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2016
First posted: Nov 17, 2015
Registry last updated: Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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