CTRI/2017/07/008974尚未招募未知
Feasibility Study of an 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
- 尚未招募
- 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 one urinary stoneâ??
- •apparent on a computed tomography (CT) scan within
- •the last 14 days.
- •2. Males and females aged 18 or older 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. Stone size, as estimated by pre-operative CT, with
- •all dimensions 15 mm or less.
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
- •4. Individuals not following up in the treating
- •5. Individuals with history of cystinuria.
- •6. Individuals with urine pH below 5.5.
- •7. Individuals with untreated urinary tract
- •8. Individuals who are not willing to use adequate
- •method of contraception during the study period.
- •9. Women who are pregnant, lactating or planning
- •pregnancy during the study period. 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. Individuals with a BMI greater than 35.
- •13. Individuals with ASA score of 3 or greater
- •general anesthesia risk level
- •14. Known sensitivity to possible medications used
- •before, during, or after the ELS procedure,
- •including but not limited to the following:
- •sedative agents, general anesthetics, topical
- •anesthetics, and opioid analgesics.
研究者
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A clinical trial to study the safety and initial efficacy of a medical device known as Enhanced Lithotripsy System (ELS) to fragment & remove Urinary stones.CTRI/2017/03/008220Applaud Medical Inc
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