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OpenTrials
Completed

NCT Number: NCT04192474

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

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.

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Key information

Conditions

Cystoscope Bladder Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev Hospital, Herlev, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flexible Cystoscopy

Device

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

Primary outcomes

  1. Performance of the cystoscope

    Time frame: follow up immediately after procedure

    Rate of completion of procedure with Ambu® aScope™ 4 Cysto and aView™ Urologia (yes/no, yes applies to 80% of the procedures)

Secondary outcomes

  1. Overall performance

    Time frame: follow up immediately after procedure

    The overall performance will be further assessed by using a 5-point Likert scale with a minimum of one (=worst possible) to maximum of five (=best possible), to be completed by the investigator that performed the cystoscopy

  2. Procedure time

    Time frame: follow up immediately after procedure

    Procedure time in minutes

  3. Patient Tolerance

    Time frame: follow up immediately after procedure

    Patient tolerance to the procedure measured by 10-points visual analogue scale (VAS) after the flexible cystoscopy. VAS from 0= minimum discomfort and 10=maximum discomfort.

  4. Adverse events

    Time frame: follow up immediately after procedure

    Adverse events evaluation during and immediately after procedure

  5. Adverse events

    Time frame: follow-up at 7 days after procedure

    Adverse events from discharge up to 7 days post-procedure (follow-up call)

Sponsors and collaborators

Lead sponsor

Ambu A/S

Industry

Collaborators

  • QserveCRO

Registry information

Official study title

Clinical Investigation to Evaluate the Performance and Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for Flexible Cystoscopy

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 10, 2019
Registry last updated
Oct 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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