CIS-014 Evaluation of Performance and Safety of aScope 4 Cysto
Research type
Research Study
Full title
Clinical investigation to evaluate the performance and safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for flexible cystoscopy
IRAS ID
278634
Contact name
Jacob Mark Patterson
Contact email
Sponsor organisation
Ambu AS
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 7 days
Research summary
The purpose of this study is to investigate the performance and safety of a new cystoscope, called aScope 4 Cysto, for the use in flexible cystoscopy and if the aScope 4 Cysto performs as well as other routinely used cystoscopes for diagnostic and procedural purposes. The main difference between currently available cystoscopes used at the hospital and the investigational cystoscope is that the aScope 4 Cysto is developed for single use. During the cystoscopy procedure, the aScope 4 Cysto is used for a diagnosis of a condition of the bladder and urethra, followed by a procedure in 50% of the cases. For a procedure, an additional tool will be guided through the aScope 4 Cysto. The additional tool will be able to take a piece of tissue (biopsy), remove damaged tissue, remove a stent or give a botox injection. The study includes screening, consent process, basic medical examination, 30 minutes cystoscopy procedure and a follow-up call after 7 days. A total of 80 patients are planned for the study.
The performance of the aScope 4
Cysto will be evaluated via a phone call
seven days after the procedure.
During the call the Investigator or a
member of their team will complete a
questionnaire to provide a qualitative
assessment of the participant’s
experiences. The results obtained will
be reviewed and analysed as per the
statistical plan for the study.REC name
West of Scotland REC 4
REC reference
20/WS/0088
Date of REC Opinion
19 Aug 2020
REC opinion
Further Information Favourable Opinion