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

NCT04829461 | Completed FDA Device

• 1 other identifier: CIS-023
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 3

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.

Conditions

Cystoscopy; Ureteral Stent

Keywords

Ureteral Stent; aScope 4 Cysto; single-use cystoscope

Outcome Measures

Primary Outcomes (1)

• 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.

  Procedure Date (Day 0)

Secondary Outcomes (4)

• 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.

  Procedure Date (Day 0)

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

  Procedure Date (Day 0)

• To evaluate the user experience during cystoscopic procedures.

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

• Safety Endpoints

  7-10 Days Post-Procedure

Study Arms (2)

Ambu® aScope™ 4 Cysto

EXPERIMENTAL

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

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

Standard of Care (SOC)

ACTIVE COMPARATOR

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

Device: Standard of care reusable cystoscope used for stent removal

Interventions

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

Procedure using a single-use cystoscope for stent removal

Ambu® aScope™ 4 Cysto

Standard of care reusable cystoscope used for stent removal DEVICE

Procedure using a reusable cystoscope for stent removal

Standard of Care (SOC)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ambu Inc.: lead
• Ambu A/S: collaborator

Study Sites (3)

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

Hershey, Pennsylvania, 17033, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

Related Publications (8)

• Samplaski MK, Jones JS. Two centuries of cystoscopy: the development of imaging, instrumentation and synergistic technologies. BJU Int. 2009 Jan;103(2):154-8. doi: 10.1111/j.1464-410X.2008.08244.x. Epub 2008 Dec 8.

  PMID: 19076146 BACKGROUND

• O'Sullivan DC, Chilton CP. Flexible cystoscopy. Br J Hosp Med. 1994 Apr 6-19;51(7):340-5.

  PMID: 8081563 BACKGROUND

• Pillai PL, Sooriakumaran P. Flexible cystoscopy: a revolution in urological practice. Br J Hosp Med (Lond). 2009 Oct;70(10):583-5. doi: 10.12968/hmed.2009.70.10.44626.

  PMID: 19966704 BACKGROUND

• Gee JR, Waterman BJ, Jarrard DF, Hedican SP, Bruskewitz RC, Nakada SY. Flexible and rigid cystoscopy in women. JSLS. 2009 Apr-Jun;13(2):135-8.

  PMID: 19660204 BACKGROUND

• Kadi N, Menezes P. ABC of flexible cystoscopy for junior trainee and general practitioner. Int J Gen Med. 2011;4:593-6. doi: 10.2147/IJGM.S20267. Epub 2011 Aug 19.

  PMID: 21887113 BACKGROUND

• Miner N, Harris V, Lukomski N, Ebron T. Rinsability of orthophthalaldehyde from endoscopes. Diagn Ther Endosc. 2012;2012:853781. doi: 10.1155/2012/853781. Epub 2012 May 16.

  PMID: 22665966 BACKGROUND

• Sokol WN. Nine episodes of anaphylaxis following cystoscopy caused by Cidex OPA (ortho-phthalaldehyde) high-level disinfectant in 4 patients after cytoscopy. J Allergy Clin Immunol. 2004 Aug;114(2):392-7. doi: 10.1016/j.jaci.2004.04.031.

  PMID: 15316522 BACKGROUND

• Johnson BA, Raman JD, Best SL, Lotan Y. Prospective Randomized Trial of Single-Use vs Reusable Cystoscope for Ureteral Stent Removal. J Endourol. 2023 Oct;37(10):1139-1144. doi: 10.1089/end.2023.0134.

  PMID: 37565290 DERIVED

Study Officials

• Elizabeth Smith

  Ambu Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 2, 2021
• Study Start: April 27, 2021
• Primary Completion: July 15, 2022
• Study Completion: July 20, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)