Single-use Cystoscope System for Direct Visualization of the Urethra and Bladder

NCT04190641 | Completed

• 1 other identifier: CIS-013
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the new aScope 4 Cysto is used to see how well it visualizes the lower urinary tract, and if this new flexible cystoscope performs as well as other routinely used cystoscopes. This study will be done in patients who have been diagnosed with bladder lesions and who will undergo surgery via the urethra to remove these lesions. The surgery is done under general anesthesia. After being brought under anesthesia and before removal of the lesion(s), the new flexible cystoscope is tested. The cystoscope will be used to visualize the urethra and bladder. Data will be collected on the number of the lesions that can be seen using the new cystoscope. During the planned surgery a resectoscope or rigid cystoscope will be used to confirm the number of lesions. The data will be used to show how well the cystoscope visualizes the lesions in comparison with routinely used cystoscopes. It will give information on how well the structures of the urinary tract and bladder can be viewed including any abnormalities that are present.Data will also be collected on the handling of the cystoscope: how well the cystoscope moves into the lower urinary tract, and how well it can be navigated through the lower urinary tract.

Conditions

Cystoscope; Bladder Cancer; Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• performance of Ambu® aScope™ 4 Cysto and aView™ Urologia

  The performance level of Ambu® aScope™ 4 Cysto and aView™ Urologia, compared to current standard practice with re-usable cystoscopes, is defined as proportion of patients with one or more papillary bladder lesion or small resectable lesion (diagnosed a maximum of one month prior to resection) detected with the Ambu® aScope™ 4 Cysto and aView™ Urologia (prior to planned transurethral resection of bladder tumors (TURBT)) and confirmed with the rigid cystoscope during TURBT.

  follow up immediately after procedure

Secondary Outcomes (3)

• Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia

  follow up immediately after procedure

• Investigator performance

  follow up immediately after procedure

• Procedure time

  follow up immediately after procedure

Study Arms (1)

Flexible cystoscopy

OTHER

Visualization of the urethra and bladder with the Ambu® aScope™ 4 Cysto and aView™ Urologia

Device: Ambu aScope 4 Cysto and aView Urologia

Interventions

Ambu aScope 4 Cysto and aView Urologia DEVICE

Visualization of the urethra and the bladder

Flexible cystoscopy

Eligibility Criteria

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

You may qualify if:

• Willing to sign the informed consent
• Adults (males and females), ≥18 years of age or older
• Able to undergo routine cystoscopy
• Patients diagnosed with papillary bladder or small resectable lesion where transurethral resection of the tumour/lesion is planned

You may not qualify if:

• 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
• Pregnant or lactating women

Sponsors & Collaborators

• Ambu A/S: lead
• QserveCRO: collaborator

Study Sites (1)

Herlev Hospital

Herlev, DK-2730, Denmark

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Model Details: A non-randomized confirmatory study

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: October 8, 2020
• Primary Completion: April 30, 2021
• Study Completion: July 6, 2021
• Last Updated: October 14, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)