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Device

Ambu® aScope™ 4 Cysto for Cystoscopy

N/A
Waitlist Available
Research Sponsored by Ambu Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-10 days post-procedure
Awards & highlights

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.

Eligible Conditions
  • Cystoscopy
  • Ureteral Stent

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-10 days post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-10 days post-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The success rate of the Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance for stent removal procedures performed in the outpatient setting.
Secondary study objectives
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 the Cumulative Procedure Time between the Ambu® aScope™ 4 cysto and the site's SOC reusable flexible cystoscope.
Safety Endpoints
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ambu® aScope™ 4 CystoExperimental Treatment1 Intervention
Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope).
Group II: Standard of Care (SOC)Active Control1 Intervention
Ureteral stent removal procedure performed with standard of care (reusable cystoscope).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal
2021
N/A
~110

Find a Location

Who is running the clinical trial?

Ambu Inc.Lead Sponsor
1 Previous Clinical Trials
248 Total Patients Enrolled
Ambu A/SIndustry Sponsor
23 Previous Clinical Trials
5,637 Total Patients Enrolled
Elizabeth SmithStudy DirectorAmbu Inc.
1 Previous Clinical Trials
248 Total Patients Enrolled
~23 spots leftby Sep 2025
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