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

Ambu

Status: Completed

Conditions: Ureteral Stent; Cystoscopy

Treatments: Device: Standard of care reusable cystoscope used for stent removal; Device: Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal

Study type: Interventional

Funder types: Industry

Identifiers

NCT04829461

CIS-023

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Ambu® aScope™ 4 Cysto

Experimental group

Description:

Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope).

Treatment:

Device: Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal

Standard of Care (SOC)

Active Comparator group

Description:

Ureteral stent removal procedure performed with standard of care (reusable cystoscope).

Treatment:

Device: Standard of care reusable cystoscope used for stent removal