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

NCT04829461 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2022-09-16

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Ambu A/S

    collaborator INDUSTRY

  • Ambu Inc.

    lead INDUSTRY

Principal Investigators

  • Elizabeth Smith · Ambu Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-27
Primary Completion
2022-07-15
Completion
2022-07-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04829461 on ClinicalTrials.gov