Use of BIP-Needles in Rheumatologic Injections

Injeq

Status: Completed

Conditions: Intra-articular Injections

Treatments: Device: Injeq Bioimpedance Probe (BIP) Needle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02605928

INJ-INAR-01

Details and patient eligibility

About

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.

Full description

Clinical device investigation

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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79 participants in 1 patient group

BIP Needle

Experimental group

Description:

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.

Treatment:

Device: Injeq Bioimpedance Probe (BIP) Needle