CTRI/2017/03/008220招募中未知
Feasibility Study of the Applaud Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stone Disease.
Applaud Medical Inc0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Individuals presenting with minimum of one urinary stone measuring at least 3mm in at least one dimension apparent on a computed tomography (CT) scan within the last 14 days.
- •2. Males and females age 18yrs or above will be included. No preference will be given to gender, although men have a higher prevalence of stone disease than women.
- •3. Capable of giving informed consent, and willing to have the informed consent process videotaped
- •4. Maximum stone size and overall stone burden, as estimated by pre-operative CT, below prescribed thresholds for certain treatment protocol variant.
排除标准
- •1. Individuals under 18 years of age
- •2. Individuals with radiolucent stones
- •3. Individuals with stones in the lower pole of kidney [This exclusion criteria does not apply for patients to be treated by a PCNL variant]
- •4. Individuals not following up in the treating hospital
- •5. Individuals with history of cystinuria
- •6. Individuals with urine pH below 5.5
- •7. Individuals with untreated urinary tract infection
- •8. Women who are pregnant
- •9. Individuals with a coagulation abnormality or taking prescription anticoagulants. Aspirin usage will be discontinued at least 7 days prior to enrollment at the discretion of the attending physician.
- •10. Individuals with mobility issues who are unable to comfortably lie still for up to 30 minutes or roll from their back to their side
- •11. Individuals belonging to a vulnerable group (pregnant, mentally disabled, physically disabled, prisoner, etc.)
- •12. [For patients to be treated by an ELS Ultrasound variant] Individuals with an estimated skin-to-stone distance greater than 13cm
- •13. [For patients to be treated by an ELS Laser variants or an ELS Ultrasound variant with general anaesthesia] Individuals with ASA score of 3 or greater general anaesthesia risk level
- •14. Known sensitivity to medications required for percutaneous nephrolithotomy, ureteroscopic procedures, cystoscopic procedures, and procedures entailing retrograde placement of material in the ureter, including but not limited to the following: sedative agents, general anaesthetics, topical anesthetics, and opioid analgesics (if patient is scheduled for specific procedure, eg, general anaesthesia)
- •The following additional exclusion criteria will apply for those patients under consideration for the ELS-Laser PCNL variants:
- •15(C): Positive preoperative urine culture within 2 weeks prior to the procedure.
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