Use of BIP-Needles in Rheumatologic Injections

NCT02605928 | Completed Results

• 1 other identifier: INJ-INAR-01
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intra-articular Injections

Keywords

Arthritis; Bioimpedance; Glucocorticoid; Intra-articular injection; Needle Guidance

Outcome Measures

Primary Outcomes (1)

• True 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

Study Arms (1)

BIP Needle

EXPERIMENTAL

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

Interventions

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.

BIP Needle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• In addition pregnant women are excluded

Sponsors & Collaborators

• Injeq Ltd: lead

Study Sites (1)

Helsinki University Hospital, Clinic of Rheumathology

Helsinki, HUS, FI-00029, Finland

Location

MeSH Terms

Conditions

Arthritis

Interventions

Needles

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: PhD MD Ritva Peltomaa
• Organization: Department of Medicine, Division of Rheumatology, Helsinki University Central Hospital and University of Helsinki, Finland

ritva.peltomaa@hus.fi

Study Officials

• Riitta Luosujärvi, PhD MD

  Helsinki University Hospital, Clinic of Rheumathology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 17, 2015
• Study Start: October 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: January 1, 2016
• Last Updated: April 4, 2017
• Results First Posted: April 4, 2017

Record last verified: 2016-12

Locations

FI (1)