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Evaluation of Performance and Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for Flexible Cystoscopy

NCT ID: NCT04192474

Last Updated: 2021-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-21

Study Completion Date

2021-06-30

Brief Summary

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In this study, the new aScope 4 Cysto is used to see if this new single use, flexible cystoscope performs as well as other routinely used flexible cystoscopes. This study will be done in patients who come to the clinic for either a diagnosis of their urethra and bladder or for a small intervention. For an intervention a lesion or tumor is resected, a stent in the ureter is taken out, or an injection in the bladder wall is given. The flexible cystoscope is passed into the urethra and bladder for visual inspection of the bladder and urethra. It will give information on how well the structures of the urinary tract and bladder can be viewed including any abnormalities that are present. If an intervention is performed the aScope 4 Cysto will be used with an endoscopic accessory.

Detailed Description

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Clinical Phase: pre-CE study

Design: A prospective, multicenter, single- arm open-label clinical study on the performance and safety of Ambu® aScope™ 4 Cysto and aView™ Urologia, a single-use, flexible cystoscope for flexible cystoscopy

Population: Adult subjects (≥ 18 years) undergoing flexible cystoscopy for diagnostic or therapeutic purposes.

Planned Sample Size: A total of 80 patients will result in a maximum (if the true proportion is 50 %) width (i.e. the difference between the point estimate and the upper, or lower, limit of the confidence interval) of the two-sided 95 % confidence interval for the binary variable "Performance level acceptable" to be 11%. This width is considered to be useful in the interpretations of the results from this part of the trial.

Study duration: Screening, procedure and follow-up will take 14 days maximum. A follow-up telephone call at 7 days post procedure is performed to record any adverse events post-procedure.

Planned Trial Period: 3 months

Investigational Device: Ambu® aScope™ 4 Cysto and aView™ Urologia. A pre-CE, single use cystoscope.

Conditions

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Cystoscope Lower Urinary Tract Symptoms Bladder Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A prospective, multicenter, single- arm open-label clinical study on the performance and safety

* 50% of the patients undergo flexible diagnostic cystoscopy
* 50% of the patients undergo flexible cystoscopy intervention with endoscopic accessories
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Flexible cystoscopy

50% of the patients undergo flexible diagnostic cystoscopy; 50% of the patients undergo flexible cystoscopy intervention with endoscopic accessories.

Group Type OTHER

Flexible cystoscopy

Intervention Type DEVICE

Treatment with the investigational device: Ambu® aScope™ 4 Cysto

Interventions

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Flexible cystoscopy

Treatment with the investigational device: Ambu® aScope™ 4 Cysto

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults (males and females), ≥18 years of age or older, presenting for cystoscopy
* Ambulatory with a need to undergo cystoscopy for diagnostic or therapeutic purposes
* Willing to participate in a clinical trial

Exclusion Criteria

* History of high-grade bladder cancer or carcinoma-in-situ of the bladder, undergoing cystoscopy for follow-up/surveillance purposes
* History of prior bladder/urethral reconstructive surgery
* Presence of symptomatic urinary tract infection (UTI)
* Known unpassable urethral stricture
* Unable to read and/or understand the study requirements
* Unable or unwilling to provide consent to participation in the study
* Pregnant or lactating women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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QserveCRO

UNKNOWN

Sponsor Role collaborator

Ambu A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Herlev Hospital

Herlev, , Denmark

Site Status

Erasmus MC

Rotterdam, , Netherlands

Site Status

Countries

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Denmark Netherlands

Other Identifiers

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CIS-014

Identifier Type: -

Identifier Source: org_study_id