Use of BIP-Needles in Rheumatologic Injections

Intra-articular Injections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02605928
• Other study ID #: INJ-INAR-01
• Status: Completed
• Phase: N/A
• First received: November 12, 2015
• Last updated: February 23, 2016
• Start date: October 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Injeq Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Valvira - National Supervisory Authority for Welfare and Health
• Study type: Interventional

Clinical Trial 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.

Description:

Clinical device investigation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: January 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Intra-articular Injections

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Finland	Helsinki University Hospital, Clinic of Rheumathology	Helsinki	HUS

Sponsors (1)

Lead Sponsor	Collaborator
Injeq Ltd

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	True and false 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	No