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Clinical Trials/NCT04192474
NCT04192474CompletedNot Applicable

Clinical Investigation to Evaluate the Performance and Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for Flexible Cystoscopy

Ambu A/S4 sites in 2 countries83 target enrollmentStarted: July 21, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Ambu A/S
Enrollment
83
Locations
4
Primary Endpoint
Performance of the cystoscope

Study Overview

Brief Summary

In this study, the new aScope 4 Cysto is used to see if this new single use, flexible cystoscope performs as well as other routinely used flexible cystoscopes. This study will be done in patients who come to the clinic for either a diagnosis of their urethra and bladder or for a small intervention. For an intervention a lesion or tumor is resected, a stent in the ureter is taken out, or an injection in the bladder wall is given. The flexible cystoscope is passed into the urethra and bladder for visual inspection of the bladder and urethra. It will give information on how well the structures of the urinary tract and bladder can be viewed including any abnormalities that are present. If an intervention is performed the aScope 4 Cysto will be used with an endoscopic accessory.

Detailed Description

Clinical Phase: pre-CE study

Design: A prospective, multicenter, single- arm open-label clinical study on the performance and safety of Ambu® aScope™ 4 Cysto and aView™ Urologia, a single-use, flexible cystoscope for flexible cystoscopy

Population: Adult subjects (≥ 18 years) undergoing flexible cystoscopy for diagnostic or therapeutic purposes.

Planned Sample Size: A total of 80 patients will result in a maximum (if the true proportion is 50 %) width (i.e. the difference between the point estimate and the upper, or lower, limit of the confidence interval) of the two-sided 95 % confidence interval for the binary variable "Performance level acceptable" to be 11%. This width is considered to be useful in the interpretations of the results from this part of the trial.

Study duration: Screening, procedure and follow-up will take 14 days maximum. A follow-up telephone call at 7 days post procedure is performed to record any adverse events post-procedure.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults (males and females), ≥18 years of age or older, presenting for cystoscopy
  • Ambulatory with a need to undergo cystoscopy for diagnostic or therapeutic purposes
  • Willing to participate in a clinical trial

Exclusion Criteria

  • History of high-grade bladder cancer or carcinoma-in-situ of the bladder, undergoing cystoscopy for follow-up/surveillance purposes
  • History of prior bladder/urethral reconstructive surgery
  • Presence of symptomatic urinary tract infection (UTI)
  • Known unpassable urethral stricture
  • Unable to read and/or understand the study requirements
  • Unable or unwilling to provide consent to participation in the study
  • Pregnant or lactating women

Outcomes

Primary Outcomes

Performance of the cystoscope

Time Frame: follow up immediately after procedure

Rate of completion of procedure with Ambu® aScope™ 4 Cysto and aView™ Urologia (yes/no, yes applies to 80% of the procedures)

Secondary Outcomes

  • Patient Tolerance(follow up immediately after procedure)
  • Adverse events(follow-up at 7 days after procedure)
  • Overall performance(follow up immediately after procedure)
  • Procedure time(follow up immediately after procedure)

Investigators

Sponsor
Ambu A/S
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

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