Evaluation of Performance and Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for Flexible Cystoscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms; Bladder Disease; Cystoscope
• Intervention / Treatment: Device: Flexible cystoscopy

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.

Planned Trial Period: 3 months

Investigational Device: Ambu® aScope™ 4 Cysto and aView™ Urologia. A pre-CE, single use cystoscope.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, DK-2730
    • Herlev Hospital
• Netherlands
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Flexible cystoscopy; 50% of the patients undergo flexible diagnostic cystoscopy; 50% of the patients undergo flexible cystoscopy intervention with endoscopic accessories.	Device: Flexible cystoscopy; Treatment with the investigational device: Ambu® aScope™ 4 Cysto

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of the cystoscope	Rate of completion of procedure with Ambu® aScope™ 4 Cysto and aView™ Urologia (yes/no, yes applies to 80% of the procedures)	follow up immediately after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall performance	The overall performance will be further assessed by using a 5-point Likert scale with a minimum of one (=worst possible) to maximum of five (=best possible), to be completed by the investigator that performed the cystoscopy	follow up immediately after procedure
Procedure time	Procedure time in minutes	follow up immediately after procedure
Patient Tolerance	Patient tolerance to the procedure measured by 10-points visual analogue scale (VAS) after the flexible cystoscopy. VAS from 0= minimum discomfort and 10=maximum discomfort.	follow up immediately after procedure
Adverse events	Adverse events evaluation during and immediately after procedure	follow up immediately after procedure
Adverse events	Adverse events from discharge up to 7 days post-procedure (follow-up call)	follow-up at 7 days after procedure

Collaborators and Investigators

• Sponsor: Ambu A/S
• Collaborators: QserveCRO

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2020
• Primary Completion (Actual): April 7, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Lower Urinary Tract Symptoms; Urinary Bladder Diseases
• Other Study ID Numbers: CIS-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No