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TELAXMAN - Laser Lithotripsy With Automatic Real-time Stone Recognition

NCT05500534 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-08-21

No results posted yet for this study

Summary

Urolithiasis is an extremely common disease affecting about 12% of the world population with increasing tendency. Urinary stones are sediments that form in the kidney from crystals, such as calcium oxalate.

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.

Conditions

  • Lithotripsy, Laser

Interventions

DEVICE

Laser lithotripsy with stone recognition

Application of Revolix HTL+ which features automatic real-time stone recognition

OTHER

Laser lithortripsy

Standard laser lithotripsy

Sponsors & Collaborators

  • LISA Laser Products GmbH

    lead INDUSTRY

Principal Investigators

  • Martin Schönthaler, Prof. Dr. · Universitätsklinikum Freiburg

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-05
Primary Completion
2024-08-13
Completion
2024-08-13

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05500534 on ClinicalTrials.gov