Effectiveness of Ambu® aScope™ 4 Cysto With the aView™ 2 Advance for Flexible Cystoscopy

Ambu Inc.102 enrolled

Overview

The purpose of this study is to evaluate the use of the single-use Ambu® aScope™ 4 Cysto for removal of ureteral stents as compared to routine flexible reusable cystoscopes.

This study is a prospective, randomized, multi-center, post-market investigation of the effectiveness of Ambu® aScope™ 4 Cysto (single-use cystoscope) as compared to routine flexible reusable cystoscopes (standard of care) for ureteral stent removals. The investigation will include approximately 102 subjects (randomized at a 1:1 ratio).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Cystoscopy Ureteral Stent

Interventions

Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removalDEVICE

Procedure using a single-use cystoscope for stent removal

Standard of care reusable cystoscope used for stent removalDEVICE

Procedure using a reusable cystoscope for stent removal

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult (male or female), ≥18 years old 2. Patient undergoing routine flexible cystoscopy 3. Patient with a ureteral stent in the urinary system that is ready to be removed. 4. No active urinary tract infection 5. Subject is willing and able to sign informed consent and HIPAA authorization and comply with requirements of the protocol. Exclusion Criteria: 1. History of prior bladder/urethral reconstructive surgery. 2. History of high-grade bladder cancer or carcinoma in-situ of the bladder, undergoing cystoscopy for follow-up/surveillance purposes. 3. Known unpassable urethral stricture 4. Febrile patient with active urinary tract infection (UTI) 5. Subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis) 6. Subject with severe coagulopathy 7. Patient is unable to read and/or understand study requirements 8. Patient is unable or unwilling to provide written consent to participate in the study. 9. Subject, in the opinion of the Investigator, has a severe comorbidity, poor general physical/mental health and/or a condition that will not

Locations (3)

The Pennsylvania State University and The Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

The success rate of the Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance for stent removal procedures performed in the outpatient setting.

Stent removal procedural success rate with the Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance.

Time frame: Procedure Date (Day 0)

Secondary Outcomes

Comparison of Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance for stent removal procedures performed in the outpatient setting to standard of care reusable scopes on scope performance.

Comparison of Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance for stent removal procedures performed in the outpatient setting to standard of care reusable scopes on scope performance as measured by procedure success rates, conversion rates, and device deficiency rates.

Time frame: Procedure Date (Day 0)

Comparison of the Cumulative Procedure Time between the Ambu® aScope™ 4 cysto and the site's SOC reusable flexible cystoscope.

Comparison of the Cumulative Procedure Time between the Ambu® aScope™ 4 cysto and the site's SOC reusable flexible cystoscope as measured by: 1. Scope preparation for procedure 2. Actual procedure time (insertion of cystoscope to removal of cystoscope) and 3. Time to dispose of or prepare for reprocessing of cystoscopy equipment.

Time frame: Procedure Date (Day 0)

To evaluate the user experience during cystoscopic procedures.

Clinician satisfaction rated on a five-point scale (1-5) with 5 being the better outcome. 1. Ease of insertion 2. Ability to visualize anatomical landmarks and/or urothelium changes 3. Perception of image quality 4. Maneuverability in the bladder 5. Scope articulation with tools in the working channel 6. Visualization while tools are in the working channel

Time frame: Clinician Questionnaire; completed within one (1) day of procedure date (Day 0).

Safety Endpoints

Data from ClinicalTrials.gov

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