NCT05561127招募中3 期
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel
GIE Medical64 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2023年11月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 171
- 试验地点
- 64
- 主要终点
- Freedom from Stricture Recurrence
研究概览
简要总结
To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.
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
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of symptomatic benign bowel stricture with at least 2 previous dilations.
- •Willing and able to complete protocol required follow up
- •Willing and able to provide written informed consent
- •Stricture length ≤ 5 cm
排除标准
- •Female subjects who are pregnant or breastfeeding or plan to get pregnant in next 12 months
- •Contraindication to endoscopy, anesthesia, or deep sedation.
- •Suspicion of malignant bowel stricture NOTE: Biopsy should be taken for every stricture during the initial endoscopy, however endoscopic balloon dilation may proceed without awaiting results if suspicion for malignancy is low in the opinion of the investigator.
- •Benign stricture due to extrinsic compression
- •Stricture is not amenable to standard balloon dilation (e.g. severe angulation, unable to pass guidewire, etc.)
- •Stricture complicated with abscess, fistula, perforation, leakage or varices
- •Stricture segment has moderate to severe active inflammation at the time of treatment. Moderate to severe inflammation is defined as any one of; ulcers >0.5cm in diameter, ulcerated surface >10%, affected (inflamed) surface >50%, marked erythema, absent vascular pattern, significant friability, or erosions
- •Multiple clinically significant strictures unable to be treated with a single balloon (i.e. total segment length must be ≤5cm) NOTE: Clinically significant strictures include those that are unable to be passed by the endoscope.
- •Received steroid injections into target stricture in the last 8 weeks
- •Stricture is not able to be dilated to ≥15mm in small bowel or ≥18mm in large bowel
- •Diagnosis of metastatic cancer of any type that is not considered in remission or non-metastatic cancer that may require radiation treatment in the pelvic region (e.g. prostate cancer)
- •Suspected perforation of gastrointestinal tract
- •Active systemic infection
- •Allergy to paclitaxel
- •Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per relevant societal guidelines
- •Chronic systemic steroid use (defined as greater than 10 mg/day) for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use
- •Condition requiring treatment in urgent setting
- •Life expectancy of less than 24 months
- •Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety, such as recent myocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracic aneurysm, pharyngeal or cervical deformity, etc.
- •Current participation in another pre-market drug or medical device clinical study unless in long term follow-up
结局指标
主要结局
Freedom from Stricture Recurrence
时间窗: 6 Months Post-Treatment
Endoscopic Obstruction Scale (EOS) of \> 1 when using a pediatric colonoscope or equivalent
Primary Safety Outcome
时间窗: 30 Days Post-Treatment
Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion)
次要结局
- Improvement in GIQLI-10 score(6 Months Post-Procedure)
- Freedom from clinically driven target stricture reintervention(6 Months Post-Procedure)
研究者
研究点 (64)
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