Use of BIP-Needles in Rheumatologic Injections

NCT ID: NCT02605928

Last Updated: 2017-04-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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Clinical device investigation

Conditions

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Intra-articular Injections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Injeq Bioimpedance Probe (BIP) Needle

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult patients having an inflammatory rheumatic disease requiring an intra-articular glucocorticoid injection.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Injeq Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Riitta Luosujärvi, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Hospital, Clinic of Rheumathology

Locations

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Helsinki University Hospital, Clinic of Rheumathology

Helsinki, HUS, Finland

Site Status

Countries

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Finland

Other Identifiers

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INJ-INAR-01

Identifier Type: -

Identifier Source: org_study_id

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