RetroPerc®-A Prospective, Multi-institutional Trial of Efficacy of the RetroPerc Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Proportion of successful renal access per access attempts
研究概览
简要总结
The goal of this observational study is to learn about the benefit of using RetroPerc® in obtaining renal access for percutaneous nephrolithotomy. The device is already used in routine clinical practice by urologists around the country.
Participants who are already scheduled to undergo percutaneous nephrolithotomy as part of their regular care will be asked to participate.
详细描述
Retrograde nephrostomy access is well established as a safe method for nephrostomy creation and thus this study aims to perform a standard of care study. The device is already available, on the shelf, and used in routine clinical care. However, the study aims to take a closer look in a prospective fashion at this access technique to better understand specific variables that are not available on retrospective review of cases that have already undergone PCNL with this technique.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Renal stone or total linear sum of 1.5-3cm cm in maximum dimension (largest diameter in axial or coronal)--- multiple stones should be summed to determine stone size.
- •Age >=18 years of age
- •Gender: both men and women included.
- •Ethnic background: all ethnicities will be included in the study population and the specific ethnic diversity present in the study population will reflect the geographic distributions of the participating institutions.
- •Plan for PCNL in the supine position
排除标准
- •Active pregnancy
- •Severe Hydronephrosis - renal pelvis diameter > 20mm
- •Flank window < 4 cm are ineligible for puncture
- •Previous ipsilateral PCNL
- •Currently with "useful" nephrostomy tube on ipsilateral side
- •Uncorrectable coagulopathies
- •Untreated urinary tract infection
- •Subjects with significant morbidities such as American Society of Anesthesiologists (ASA) score ≥ 4, severe spinal cord injuries, severe cardiopulmonary insufficiency, uncontrolled diabetes, neurological disorders, bedbound, anticipated life expectancy less than 5 years, or any other comorbidity, that in the opinion of the principal investigator could represent an increased peri-operative risk for the subject;
- •Ipsilateral partial nephrectomy
- •History of ipsilateral ureteral reimplantation or ureteral reconstruction;
- •History of Simple or radical prostatectomy
- •History of cystectomy
- •History of calyceal diverticula stone;
- •History of renal donation or transplant;
- •Any other previous pelvic surgical treatment that could put the subject at greater procedural complication risk or technical difficulty;
- •Ureteral ipsilateral stricture, untreated;
- •Ureteral stricture, untreated (not to include "tight" ureter);
- •Any other bladder, ureteral or kidney congenital genitourinary abnormalities (e.g. Horseshoe kidney, ipsilateral duplicated or partially duplicated collecting system, ipsilateral ectopic kidney, cross-fused ectopia, bifid renal pelvis with no horizontally directed calyces, solitary kidney, etc.) preventing the ability to direct a puncture laterally or render the subject stone free;
- •Have participated in any other clinical trial within the last 3 months, and/or plans to participate in any other investigational or invasive clinical trial during this study;
- •If female, breast-feeding, or if childbearing age, is not using contraception between screening and 90 days post-op;
- •Subject has current or recent history of substance abuse (e.g. recreational drugs, narcotics, or alcohol) requiring intervention;
- •Is a prisoner or ward of the state;
- •Is unable to meet the treatment and follow up protocol requirements.
研究组 & 干预措施
Percutaneous Nephrolithotomy
Participants with a single renal stone or total sum of 1.5 to 3 cm in maximum dimension of multiple stones undergoing percutaneous nephrolithotomy as part of their routine medical care using the RetroPerc® system to obtain renal access.
干预措施: RetroPerc® (Device)
结局指标
主要结局
Proportion of successful renal access per access attempts
时间窗: Procedure
The proportion of successful renal access was compared to the renal access attempts (e.g. 100 success attempts/110 attempts).
次要结局
- Location of Renal Access(Procedure)
- Time to gain renal access(Procedure)
- Length of Post-Operative Hospital Stay(Day 0 to 3 Months Post-Operative)
- Total Procedure Time(Procedure)
研究者
Bristol Whiles, MD
Assistant Professor
University of Kansas Medical Center