NCT04829461

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Ambu Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 cystoscopes (standard of care) for ureteral stent removals. The investigation will include approximately 102 subjects (randomized at a 1:1 ratio).

Conditions

• Cystoscopy
• Ureteral Stent

Interventions

Type	Name	Description
DEVICE	Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal	Procedure using a single-use cystoscope for stent removal
DEVICE	Standard of care reusable cystoscope used for stent removal	Procedure using a reusable cystoscope for stent removal

Timeline

• Start date: 2021-04-27
• Primary completion: 2022-07-15
• Completion: 2022-07-20
• First posted: 2021-04-02
• Last updated: 2022-09-16

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study