TELAXMAN - Laser Lithotripsy With Automatic Real-time Stone Recognition
NCT ID: NCT05500534
Last Updated: 2024-08-21
Study Results
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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COMPLETED
NA
40 participants
INTERVENTIONAL
2022-09-05
2024-08-13
Brief Summary
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Currently, urological endoscopy with laser lithotripsy represents the leading and most frequently used method for the treatment of urinary stones of different localization, size and composition.
Surgical urology, including interventional stone treatment, is highly influenced by technology. With regard to fragmentation properties and effectiveness for all stone types Holmium:yttrium-aluminium-garnet (Ho:YAG) laser lithotripsy has become the standard technology to disintegrate urinary calculi.
In addition, other kinds of lasers are emerging, such as the thulium fiber laser (TFL); a new solid-state, diode-pumped laser that may provide urologists with increased options for stone treatment.
While urolithiasis treatment in general and laser lithotripsy in specific rarely goes along with major complications, recent studies have shown that there are possible indirect risks to the treatment with lasers, such as thermal damages to the urinary tract even at low-power settings if inadequate irrigation is applied. Sufficient irrigation is mandatory to perform safe Ho:YAG laser lithotripsy.
The RevoLix HTL+ automatic real-time stone detection module was developed to overcome these limitations and improve the safety of the patient with regard to potential thermal damages.
The objective of this clinical investigation is to assess the feasibility of stone recognition and disintegration with the RevoLix HTL+ in clinical conditions and to identify hypotheses to be used in future clinical investigations.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RevoLix HTL+
Laser lithotripsy using the RevoLix HTL+ with active stone recognition
Laser lithotripsy with stone recognition
Application of Revolix HTL+ which features automatic real-time stone recognition
Historic control group
Laser lithotripsy without active stone recognition
Laser lithortripsy
Standard laser lithotripsy
Interventions
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Laser lithotripsy with stone recognition
Application of Revolix HTL+ which features automatic real-time stone recognition
Laser lithortripsy
Standard laser lithotripsy
Eligibility Criteria
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Inclusion Criteria
* Subject aged 18 or older
* Subject able to give consent
* Informed consent documented by signature
Exclusion Criteria
* Subject requiring emergency lithotripsy
* Contraindication for the surgical procedure:
* Positive urine culture,
* Unfit for general anesthesia,
* Therapeutic anticoagulation, or systemic infection
18 Years
ALL
No
Sponsors
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LISA Laser Products GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Schönthaler, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Freiburg
Locations
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Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Countries
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Other Identifiers
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TELAXMAN
Identifier Type: -
Identifier Source: org_study_id
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