Clinical trial NCT05500534: TELAXMAN - Laser Lithotripsy With Automatic Real-time Stone Recognition
Official title: Exploratory Feasibility Study of a Novel Laser System for Endoscopic Disintegration of Urinary Stones With Automatic Real-time Stone Recognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lithotripsy, Laser
Lead sponsor: LISA Laser Products GmbH
Sponsor class: INDUSTRY
First posted: 2022-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Study participants will be scheduled for laser lithotripsy using the investigational device. A comparator arm will also be included, being composed of retrospective, anonymised and non-study related data of patients who underwent laser lithotripsy with a device used in routine lithotripsy interventions at the investigational site.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Subject scheduled for laser lithotripsy
* Subject aged 18 or older
* Subject able to give consent
* Informed consent documented by signature

Exclusion Criteria:

* Subject pregnant or nursing
* Subject requiring emergency lithotripsy
* Contraindication for the surgical procedure:

  * Positive urine culture,
  * Unfit for general anesthesia,
  * Therapeutic anticoagulation, or systemic infection

Primary outcomes:
measure: Visual assessment of stone-free status;
timeFrame: During the procedure of laser lithotripsy, which should last for a maximum of 5 hours
measure: Visual assessment of stone, tissue and endoscope recognition accuracy during laser lithotripsy
timeFrame: During the procedure of laser lithotripsy, which should last for a maximum of 5 hours
measure: Safety of device - assessment of device deficiencies
timeFrame: During laser lithotripsy (duration of max 5 hours)
measure: Safety of device - assessment of adverse events during the intervention
timeFrame: During laser lithotripsy (duration of max 5 hours)
measure: Safety of device - assessment of adverse events during the follow up time
timeFrame: During the follow up time (up to 3 months)
measure: New risk identification during the intervention
timeFrame: Within 12 hours after the intervention
measure: New risk identification during the follow up time
timeFrame: During the follow up time (up to 3 months)
Secondary outcomes:
measure: Total laser emitted energy (J)
timeFrame: Immediately (up to 1 hour) after the end of the intervention
measure: Procedure duration (min)
timeFrame: Immediately (up to 1 hour) after the end of the intervention
measure: PULS classification of potential lesions visible via endoscopy immediately after the procedure
timeFrame: During the procedure of laser lithotripsy, which should last for a maximum of 5 hours
measure: Usability and workflow assessment (surgeon's questionnaire)
timeFrame: Within 12 hours after the intervention
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
Study officials:
affiliation: Universitätsklinikum Freiburg
name: Martin Schönthaler, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: