Status:
COMPLETED
Effectiveness of Ambu® aScope™ 4 Cysto With the aView™ 2 Advance for Flexible Cystoscopy
Lead Sponsor:
Ambu Inc.
Collaborating Sponsors:
Ambu A/S
Conditions:
Cystoscopy
Ureteral Stent
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed 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 cystosco...
Eligibility Criteria
Inclusion
- Adult (male or female), ≥18 years old
- Patient undergoing routine flexible cystoscopy
- Patient with a ureteral stent in the urinary system that is ready to be removed.
- No active urinary tract infection
- Subject is willing and able to sign informed consent and HIPAA authorization and comply with requirements of the protocol.
Exclusion
- History of prior bladder/urethral reconstructive surgery.
- History of high-grade bladder cancer or carcinoma in-situ of the bladder, undergoing cystoscopy for follow-up/surveillance purposes.
- Known unpassable urethral stricture
- Febrile patient with active urinary tract infection (UTI)
- Subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis)
- Subject with severe coagulopathy
- Patient is unable to read and/or understand study requirements
- Patient is unable or unwilling to provide written consent to participate in the study.
- Subject, in the opinion of the Investigator, has a severe comorbidity, poor general physical/mental health and/or a condition that will not
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2022
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04829461
Start Date
April 27 2021
End Date
July 20 2022
Last Update
September 16 2022
Active Locations (3)
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1
The Pennsylvania State University and The Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
2
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
3
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792