NCT04563039已完成不适用
Evaluation of Applaud Medical's Acoustic Enhancer With Laser Lithotripsy System in the Treatment of Urinary Stones
Avvio Medical43 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2021年5月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 43
- 主要终点
- Number of Participants With Absence of or Have Residual Fragments Measuring Less </= to 2 mm
研究概览
简要总结
A pivotal study to evaluate the safety and effectiveness of Applaud Acoustic Enhancer when used in conjunction with conventional ureteroscopic laser lithotripsy (URS-LL) in the treatment of subjects with urinary stones.
详细描述
The AEROLITH Clinical Study will evaluate the safety and effectiveness of Applaud Acoustic Enhancer when used in conjunction with conventional ureteroscopic laser lithotripsy (URS-LL) in the treatment of subjects with urinary stones. The clinical study is a prospective, multi-center, two-arm, randomized, double blinded study.
A total of 196 subjects will be enrolled in this study at up to 27 investigational sites located in the U.S.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged ≥ 18 years to ≤ 75 years
- •Provides written informed consent
- •Patients with at least one urinary stone measuring 6mm or greater (but no more than a cumulative diameter of 20mm) located proximally to the iliac vessels on one side may be treated.
- •Urinary stone(s) should be apparent on a CT scan within 60 days prior to study enrollment. Stone assessment will be conducted using CT imaging following CLIN-0025: AEROLITH IDE Study Screening Guide.
- •Patients with bilateral stones are allowed but only one side may be treated. Only the treated side will be evaluated for safety and effectiveness
- •Patients may enter the study with a stent in place.
- •Patients presenting with absence of a Urinary Tract Infection as confirmed using urinalysis
排除标准
- •Patients with stones exceeding a cumulative diameter of 20mm on the side to be treated. Note: Punctate stones measuring ≤ 2mm do not count in the cumulative diameter limit.
- •Patients with ureteral stones located distal to the iliac vessels on the side to be treated
- •Diagnosis of radiolucent stones (on the side to be treated) on KUB or Scout CT Imaging
- •For patients who have a ureteral stent in place, patient is excluded if stent is calcified or encrusted as verified using standard of care imaging (e.g. KUB X-ray)
- •Patients who have had prior URS-LL within 3 months on the side to be treated at the time of consent.
- •History of cystinuria
- •Urine pH is < 5.
- •Patients with known history of recurrent uric acid stones
- •Untreated urinary tract infection (UTI)
- •History of drug-resistant chronic UTI
- •If female, pregnant as confirmed using urine test to be conducted on the day of the procedure.
- •Patient has an American Society of Anesthesiologists (ASA) physical classification level of 4 or greater.
- •Known sensitivity to possible medications used before, during, or after the URS Laser Lithotripsy procedure, including but not limited to the following: sedative agents, general anesthetics, topical anesthetics, and opioid analgesics
- •Stones suspected in calyceal diverticula
- •Horseshoe kidney
- •Congenitally ectopic pelvic kidneys
- •Full staghorn calculi >2cm
- •Patients with elevated serum creatinine > 1.5mg/dl
- •Patients with a solitary kidney
- •Malrotated kidney on the side with urinary stone
- •Duplicated collecting system or duplicated ureters
- •Patients who are currently involved in any investigational drug or device trial or have been enrolled in such trials within 30 days of index procedure
- •Patients who are actively taking antiplatelet and anti-coagulation except low dose aspirin
- •Prostate biopsy within the last 3 months
- •History of radiation therapy of abdomen and pelvis
- •History of urinary tract reconstruction
- •Other factors that the investigator feels would interfere with the participation and completion of the study such as:
- •Inability to provide voluntary consent
- •Inability to understand the clinical investigation or cooperate with investigational procedures
- •Planned relocation or unable to return for required follow-up visits
- •Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)
结局指标
主要结局
Number of Participants With Absence of or Have Residual Fragments Measuring Less </= to 2 mm
时间窗: At 30 days post index procedure
Study subjects who present with a complete absence of stones, or have residual fragments measuring less than or equal to 2 mm on the treatment side, as assessed by CT imaging
次要结局
未报告次要终点
研究者
研究点 (43)
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