Surgical Outcomes and Costs in Using the Shenzhen HugeMed 6.3 French Flexible Ureteroscope
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- To evaluate and compare outcomes and costs associated with hugeMed 6.3 Fr flexible URS versus traditional approach in RIRS
研究概览
简要总结
Comprehensive comparative investigations between HugeMed HU30M 6.3 Fr f-URS and traditional approach f-URS devices in RIRS are lacking in an American population. The investigators aim to compare the outcomes of using the 6.3 Fr f-URS versus traditional approach (other f-URS present in our institution) to treat patients with stone burden ≤ 2.5 cm. The findings of this study will expand on the potential advantages and drawbacks of HU30M in enhancing surgical outcomes and patient safety in RIRS procedures. We hypothesize that the use of the HU30M will result in increased cost savings while providing similar stone free rates when compared to traditionally used f-URS devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Males or females ≥ 18 years of age
- •Patients with ureteral or kidney stones undergoing primary flexible ureteroscopy for retrograde intrarenal surgery
- •Total stone burden ≤ 2.5 cm
排除标准
- •Undergoing bilateral stone treatment during the same procedure
- •Patients with known genitourinary anatomical abnormalities that would complicate the procedure as determined by the treating investigator
- •Uncorrected coagulopathy
- •Patients with urinary diversions
- •Chronic external urinary catheters
- •Women who are pregnant
- •Immunosuppressed patients
- •Non-elective procedures
- •Participants must not be involved in any other clinical research studies during the duration of this trial. Exceptions may be made if the investigator determines, on a case-by-case basis, that participation in another study will not adversely affect the outcomes or integrity of this trial
研究组 & 干预措施
hugemed ureteroscopy
Patients scheduled to undergo URS retrograde intrarenal surgery per standard of care will be recruited from urology clinics or OR schedules using using the 6.3 Fr f-URS . Patients may be approached and consented in clinic or pre-op.
All procedures, devices, and ancillary equipment are standard of care. There is no additional cost to the patient, only the typical standard of care costs. Participants will not be compensated for participation in the study.
干预措施: Ureteroscopy using the 6.3 Fr f-URS hugemed (Device)
hugemed ureteroscopy
Patients scheduled to undergo URS retrograde intrarenal surgery per standard of care will be recruited from urology clinics or OR schedules using using the 6.3 Fr f-URS . Patients may be approached and consented in clinic or pre-op.
All procedures, devices, and ancillary equipment are standard of care. There is no additional cost to the patient, only the typical standard of care costs. Participants will not be compensated for participation in the study.
干预措施: Hugemed 6.3 Fr f-URS (Device)
结局指标
主要结局
To evaluate and compare outcomes and costs associated with hugeMed 6.3 Fr flexible URS versus traditional approach in RIRS
时间窗: 36 months
Stone free rate, defined as the absence of residual stone fragments \> 2 mm, as determined by noncontrast CT scan performed
次要结局
未报告次要终点
研究者
Wilson Molina
Professor
University of Kansas Medical Center