TELAXMAN - Laser Lithotripsy With Automatic Real-time Stone Recognition
Not Applicable
Completed
- Conditions
- Lithotripsy, Laser
- Registration Number
- NCT05500534
- Lead Sponsor
- LISA Laser Products GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Inclusion Criteria:<br><br> - Subject scheduled for laser lithotripsy<br><br> - Subject aged 18 or older<br><br> - Subject able to give consent<br><br> - Informed consent documented by signature<br><br>Exclusion Criteria:<br><br> - Subject pregnant or nursing<br><br> - Subject requiring emergency lithotripsy<br><br> - Contraindication for the surgical procedure:<br><br> - Positive urine culture,<br><br> - Unfit for general anesthesia,<br><br> - Therapeutic anticoagulation, or systemic infection
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual assessment of stone-free status;;Visual assessment of stone, tissue and endoscope recognition accuracy during laser lithotripsy;Safety of device - assessment of device deficiencies;Safety of device - assessment of adverse events during the intervention;Safety of device - assessment of adverse events during the follow up time;New risk identification during the intervention;New risk identification during the follow up time
- Secondary Outcome Measures
Name Time Method Total laser emitted energy (J);Procedure duration (min);PULS classification of potential lesions visible via endoscopy immediately after the procedure;Usability and workflow assessment (surgeon's questionnaire)