Prospective post-market evaluation of an echogenic catheter

• Research type

  Research Study

• Full title

  Prospective post-market evaluation of an echogenic (EchoGlo™ Catheter) catheter used in a peripheral nerve block procedure.

• IRAS ID

  150672

• Contact name

  Simeon J West

• Contact email

  simeon.west@nhs.net

• Sponsor organisation

  Smiths Medical

• Clinicaltrials.gov Identifier

  NCT02136446

• Research summary

  This is a prospective, single center, randomized, patient- and operator-blinded post-market study conducted in the United Kingdom. The study will enroll a maximum of 60 patients to ensure a minimum of 40 complete data sets for analysis. After enrollment, patients will receive a paravertebral block requiring use of the test or control device. The type of catheter used for the procedure will be randomized (1:1) by clinician and the device type will only be revealed to the research staff assisting with the product set-up for the procedure. Clinicians will place the catheter using ultrasound guidance per standard medical practice and assess the visibility of the catheter using ultrasound technology. Once the catheter is placed, clinicians will assess the quality of block and answer questions on confidence of placement and ease of use due to the visibility of the catheter under ultrasound guidance. Subjects will answer questions to assess their pain levels before and after the procedure.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  14/SC/1061

• Date of REC Opinion

  9 Jul 2014

• REC opinion

  Further Information Favourable Opinion