eSense Clinical Investigation

• Research type

  Research Study

• Full title

  e۰Sense® Clinical Investigation: Assessing the Performance, Safety and Usability of e۰Sense® Electronic Catheters for Performing Urodynamic Studies

• IRAS ID

  298754

• Contact name

  Adele Campbell

• Contact email

  acampbell@laborie.com

• Sponsor organisation

  Laborie Medical Technologies

• Clinicaltrials.gov Identifier

  NCT04438499

• Duration of Study in the UK

  0 years, 1 months, 1 days

• Research summary

  The purpose of this study is to confirm the performance, safety and usability of the new e۰Sense® catheters during urodynamic testing.

  We are inviting people 21 years of age or older who need urodynamic testing to be tested with a new catheter as part of this research study. The following devices will be tested as part of this study:
  1) e۰Sense® bladder or urethra urodynamics catheter, and
  2) e۰Sense® rectal urodynamics catheter

  The e۰Sense® catheters being used in this study are almost the same as the e۰Sense® catheter on the market since 2014 with a few small design changes to improve manufacturability of the device.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  22/LO/0189

• Date of REC Opinion

  21 Jun 2022

• REC opinion

  Further Information Favourable Opinion