Intra-articular Injections Clinical Trial
Official title:
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.
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 |
Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Finland | Helsinki University Hospital, Clinic of Rheumathology | Helsinki | HUS |
Lead Sponsor | Collaborator |
---|---|
Injeq Ltd |
Finland,
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 |