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

NCT04192474 | Completed

• 1 other identifier: CIS-014
• Study Type: interventional
• Target: 83
• Locations: 2 countries
• Sites: 2

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.

Conditions

Cystoscope; Lower Urinary Tract Symptoms; Bladder Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall performance

  follow up immediately after procedure

• Procedure time

  follow up immediately after procedure

• Patient Tolerance

  follow up immediately after procedure

• Adverse events

  follow up immediately after procedure

• Adverse events

  follow-up at 7 days after procedure

Study Arms (1)

Flexible cystoscopy

OTHER

50% of the patients undergo flexible diagnostic cystoscopy; 50% of the patients undergo flexible cystoscopy intervention with endoscopic accessories.

Device: Flexible cystoscopy

Interventions

Flexible cystoscopy DEVICE

Treatment with the investigational device: Ambu® aScope™ 4 Cysto

Flexible cystoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ambu A/S: lead
• QserveCRO: collaborator

Study Sites (2)

Herlev Hospital

Herlev, DK-2730, Denmark

Location

Erasmus MC

Rotterdam, 3015 CE, Netherlands

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Urinary Bladder Diseases

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, multicenter, single- arm open-label clinical study on the performance and safety * 50% of the patients undergo flexible diagnostic cystoscopy * 50% of the patients undergo flexible cystoscopy intervention with endoscopic accessories

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 10, 2019
• Study Start: July 21, 2020
• Primary Completion: April 7, 2021
• Study Completion: June 30, 2021
• Last Updated: October 14, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); NL (1)