Status:
UNKNOWN
Performance and Safety of Lubri-cream for Pain Minimization During Urethral Catheterization and Cystoscopy
Lead Sponsor:
B. Braun Medical SA
Conditions:
Urethral Catheter; Complications
Eligibility:
All Genders
18-100 years
Brief Summary
The primary aim of this study is to collect clinical data on the performance of Lubri-cream applied in routine clinical practice. Safety and efficacy parameters of Lubri-cream in lubrication on bladd...
Detailed Description
The study is designed as a prospective, multicenter, single-group, observational study to evaluate Lubri-cream for urethral catheterization and cystoscopies lubrication. At least 2 different centers l...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Any patient who needs urethral catheterization or cystoscopy (rigid or flexible).
- Signed informed consent
Exclusion
- Contraindications as stated in the Instructions for Use
- Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures
- Inclusion in another investigational study in the field of urethral catheterization or cystoscopy which could interfere with the clinical practice regarding the application and care of the Investigational Product.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06101121
Start Date
December 1 2023
End Date
October 1 2024
Last Update
October 26 2023
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