Exploratory Feasibility Study of a Novel Laser System for Endoscopic Disintegration of Urinary Stones With Automatic Real-time Stone Recognition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Safety of device - assessment of adverse events during the follow up time
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject scheduled for laser lithotripsy
- •Subject aged 18 or older
- •Subject able to give consent
- •Informed consent documented by signature
排除标准
- •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
结局指标
主要结局
Safety of device - assessment of adverse events during the follow up time
时间窗: 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
时间窗: Within 12 hours after the intervention
The practitioner will be asked to identify any new risks arising during laser lithotripsy using the investigational device
New risk identification during the follow up time
时间窗: 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
Visual assessment of stone-free status;
时间窗: 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
时间窗: 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.
Safety of device - assessment of device deficiencies
时间窗: 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
时间窗: 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
次要结局
- Procedure duration (min)(Immediately (up to 1 hour) after the end of the intervention)
- 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)
- Usability and workflow assessment (surgeon's questionnaire)(Within 12 hours after the intervention)
- Total laser emitted energy (J)(Immediately (up to 1 hour) after the end of the intervention)