Use of BIP-Needles in Rheumatologic Injections

February 17, 2017 updated by: Injeq Ltd

INJ-INAR-01 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Clinical device investigation

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • HUS
      • Helsinki, HUS, Finland, FI-00029
        • Helsinki University Hospital, Clinic of Rheumathology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During intra-articular injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Injeq Ltd

Investigators

  • Principal Investigator: Riitta Luosujärvi, PhD MD, Helsinki University Hospital, Clinic of Rheumathology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 12, 2015

First Submitted That Met QC Criteria

November 12, 2015

First Posted (Estimate)

November 17, 2015

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

February 17, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • INJ-INAR-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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