NCT07020520招募中不适用
EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Successful treatment
研究概览
简要总结
The main objective of this clinical investigation is to assess the safety and feasibility of the Optilume DCB for treatment of ureteric strictures.
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
- •Age 18 years or older
- •Single lesion ureteric or uretero-enteric stricture less than or equal to 4.0 cm in length
- •Two functioning kidneys
排除标准
- •Treatment of the target ureter with incision or balloon dilation within 3 months of the study treatment
- •Subjects with more than one ureteric stricture
- •Subjects with target stricture in bifid or duplicated ureter
- •Known sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
- •Ureteric stricture caused by extrinsic compression of the ureter
- •Unable to endoscopically access target stricture for any reason
- •Existing stones in the ipsilateral kidney or ureter (except for asymptomatic kidney stones) that are in close proximity to the target ureteric stricture
- •Chronic renal failure treated with dialysis
- •eGFR <30 mL/min/1.73m2
- •Kidney function ≤ 25% of split function on the side with target stricture as measured by functional renogram
- •Kidney function ≤35% of split function on the side opposite target stricture as measured by functional renogram or other significant pathology or impairment that may impact renal function
- •Life expectancy less than 12 months
- •Women who are pregnant or breastfeeding
- •Women of child-bearing potential planning to get pregnant in the next year or are unwilling to use contraception over the next 12 months
- •Males unwilling to abstain or use protected sex for 30 days post treatment
- •Males unwilling to use highly effective contraception for6 months post treatment if sexual partner(s) are of child-bearing potential
- •Inability to provide legally effective informed consent
- •Unwilling or unable to meet protocol follow-up requirements
- •Participation in any interventional clinical investigation of a medical device, drug, or biologic (excluding registries) that may confound the results of the trial
- •Active systemic or urinary tract infection
- •Active malignancy in the abdomen or pelvis, or any malignancy considered considerable risk for metastasizing to the abdomen or pelvis over the next 12 months
- •Uncontrolled diabetes defined as hemoglobin A1C ≥ 8% at baseline
- •Unable to come off antiplatelet or anticoagulation medication prior to treatment to prevent bleeding complications at the discretion of the investigator
- •Any other condition that may confound the results of the trial or presents an unacceptable risk for any study-related procedure
- •Individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response
- •Presence of any condition that precludes administration of furosemide during renograms
- •Unable to tolerate contrast related to required study procedures or imaging.
- •Additional Criteria for Pharmacokinetic Substudy Inclusion Ureteric stricture measurements appropriate for treatment with a 6mm (18F) or 8mm (24F) diameter Optilume DCB Exclusion Prior treatment with any device or medical therapy that contains paclitaxel, including drug coated balloons for vascular and urethral applications
研究组 & 干预措施
Optilume
Experimental
Treatment with Optilume for ureteric stricture
干预措施: Optilume (Device)
结局指标
主要结局
Successful treatment
时间窗: 6-months post ureteral stent removal (approximately 7 months post Optilume treatment)
Rate of successful treatment defined as meeting all the following criteria: * Technical success * Freedom from retreatment of target stricture through six months post stent removal * Renogram at 6 months showing stability or improvement in split function for impacted kidney defined as split function within 10% of baseline value or improved from baseline. * T1/2 stability or improvement from baseline to 6 months for impacted kidney
次要结局
未报告次要终点
研究者
研究点 (12)
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