Ambu A/S 2019 CIS-013 Visualisation performance aScope 4 Cysto

• Research type

  Research Study

• Full title

  Clinical investigation to evaluate the direct visualization performances of Ambu® aScope™ 4 Cysto and aView™ Urologia for examination of the lower urinary tract

• IRAS ID

  275782

• Contact name

  Jacob Mark Patterson

• Contact email

  jake.patterson@nhs.net

• Sponsor organisation

  Ambu AS

• Clinicaltrials.gov Identifier

  NCT04190641

• Duration of Study in the UK

  0 years, 3 months, 1 days

• Research summary

  This study evaluates the performance of a new disposable cystoscope for the visualization of pathologies in the urinary tract. This will be done in 42 patients who are scheduled to undergo transurethral resection of bladder tumours (TURBT). While the patient is under anaesthesia for the planned operation, first an additional cystoscopy will performed using the new cystoscope. The goal is to evaluate how well the cystoscope can be used to visualize the previously diagnosed pathology, and to test the general performance of the device. The new cystoscope is then removed and the surgery continues using a standard cystoscope.

• REC name

  West of Scotland REC 4

• REC reference

  20/WS/0004

• Date of REC Opinion

  24 Apr 2020

• REC opinion

  Further Information Favourable Opinion