Lithotripsy, Laser
Conditions
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.
Interventions
DEVICELaser lithotripsy with stone recognition
Application of Revolix HTL+ which features automatic real-time stone recognition
OTHERLaser lithortripsy
Standard laser lithotripsy
Sponsors
LISA Laser Products GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New risk identification during the follow up time | During the follow up time (up to 3 months) | The practitioner will be asked to identify any new risks related to the investigational device during the follow up time |
| Safety of device - assessment of device deficiencies | During laser lithotripsy (duration of max 5 hours) | Safety of the device shall be evaluated by systematically reporting DDs and by monitoring the frequency and incidence of these events |
| Safety of device - assessment of adverse events during the intervention | During laser lithotripsy (duration of max 5 hours) | Safety of the device shall be evaluated by systematically reporting AEs and SAEs and by monitoring the frequency and incidence of these events |
| Safety of device - assessment of adverse events during the follow up time | During the follow up time (up to 3 months) | Safety of the device shall be evaluated by systematically reporting AEs and SAEs and by monitoring the frequency and incidence of these events |
| New risk identification during the intervention | Within 12 hours after the intervention | The practitioner will be asked to identify any new risks arising during laser lithotripsy using the investigational device |
| Visual assessment of stone-free status; | During the procedure of laser lithotripsy, which should last for a maximum of 5 hours | Before retracting the ureteroscope, the surgeon will visualize the postoperative ureter along its entire length and record the stone-free status in the CRF, using the following scale: 0 - No residue 1. \- Residual fragments ≤4mm 2. \- Residual fragments \>4mm Stone-free status is the state-of-the-art methodology for the description of the lithotripsy procedure, which is performed routinely at the investigation site. It does not require any additional invasive testing or procedures and it is performed intra-operatively. |
| Visual assessment of stone, tissue and endoscope recognition accuracy during laser lithotripsy | During the procedure of laser lithotripsy, which should last for a maximum of 5 hours | During the procedure, the surgeon will record every incidence of misrecognition by the RevoLix HTL+. Misrecognition is defined as inadequate laser pulse release on healthy tissue or endoscope. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure duration (min) | Immediately (up to 1 hour) after the end of the intervention | Procedure duration will be recorded in the CRF as the time from endoscope insertion to retraction (Schnitt-Naht Zeit). |
| PULS classification of potential lesions visible via endoscopy immediately after the procedure | During the procedure of laser lithotripsy, which should last for a maximum of 5 hours | Before retracting the ureteroscope, the surgeon will visualize the postoperative ureter along its entire length and record PULS classification in the CRF. PULS is a 5 grades scale (0 - No lesion; 1 - Superficial mucosal lesion and/or significant mucosal oedema/hematoma; 2 - Submucosal lesion; 3 - Perforation with less than 50% partial transection; 4 - Perforation with more than 50% partial transection; 5 - Complete transection), in which lesions are graded independently of their location and extent. In case of multiple lesions, the most severe grading is applied. |
| Usability and workflow assessment (surgeon's questionnaire) | Within 12 hours after the intervention | Immediately after his/her first procedure with RevoLix HTL+, the surgeon will fill in a questionnaire regarding the different aspects of the laser system. |
| Total laser emitted energy (J) | Immediately (up to 1 hour) after the end of the intervention | Total laser emitted energy is recorded by the laser system during each procedure. This data will be extracted after each procedure for the investigational arm and at the end of the investigation for the matching control arm. |
Countries
Germany
Outcome results
None listed