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Clinical Trials/NL-OMON54961
NL-OMON54961
Completed
Not Applicable

Clinical investigation to evaluate the performance and safety of Ambu® aScope* 4 Cysto and aView* Urologia for flexible cystoscopy. - Performance and safety aScope 4 Cysto

Ambu AS0 sites60 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Ambu AS
Enrollment
60
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Ambu AS

Eligibility Criteria

Inclusion Criteria

  • •i. Adults (males and females), \*18 years of age or older, presenting for
  • •ii. Ambulatory with a need to undergo cystoscopy for diagnostic or therapeutic
  • •iii. Willing to participate in a clinical trial

Exclusion Criteria

  • •i. History of high\-grade bladder cancer or carcinoma\-in\-situ of the bladder,
  • •undergoing cystoscopy for follow\-up/surveillance purposes
  • •ii. History of prior bladder/urethral reconstructive surgery
  • •iii. Presence of symptomatic urinary tract infection (UTI)
  • •iv. Known unpassable urethral stricture
  • •v. Unable to read and/or understand the study requirements
  • •vi. Unable or unwilling to provide consent to participation in the study
  • •vii. Pregnant or lactating women

Outcomes

Primary Outcomes

Not specified

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