NCT05561114招募中3 期
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
GIE Medical68 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2023年12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
- 198
- 试验地点
- 68
- 主要终点
- Treatment Success
研究概览
简要总结
To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal 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
- •Age ≥ 22 years
- •Diagnosis of a benign esophageal stricture with at least 2 previous dilations
- •Ogilvie Dysphagia Score of ≥2
- •Minimum esophageal lumen diameter <13 mm
- •Willing and able to complete protocol required follow-up visits
- •Willing and able to provide written informed consent
- •Strictures ≤5cm in total length
- •Target benign esophageal stricture etiologies include:
- •Peptic stricture,
- •Schatzki's ring,
- •Stricture due to prior infection,
- •Post-procedural (e.g. ESD/EMR/RFA/Cryo) stricture
- •Post surgical (e.g. anastomotic), including post curative esophagectomy with or without prior neoadjuvant chemoradiation therapy
排除标准
- •Two or more clinically significant (e.g. non-traversable) strictures with total length >5cm or unable to be treated with a single balloon.
- •Female subjects who are pregnant or breastfeeding or plan to become pregnant in next 12 months
- •Contraindication to endoscopy, anesthesia or deep sedation
- •Benign esophageal stricture due to extrinsic esophageal compression, caustic ingestion, lichen planus, and purely radiation induced strictures post head/neck cancer treatment.
- •History of diagnosis of eosinophilic esophagitis (EoE)
- •Signs or suspicion of a malignant esophageal stricture NOTE: If stricture is suspicious for malignancy based on clinical or endoscopic presentation, malignancy must be excluded by biopsy prior to enrollment. Subjects with a history of invasive esophageal cancer should have recurrence excluded by advanced imaging (e.g. CT/PET scan) and biopsy within 6 months of enrollment.
- •Diagnosis of metastatic cancer of any type that is not considered in remission or non-metastatic cancer that may require radiation treatment in the neck or thoracic region NOTE: A prior diagnosis of esophageal cancer is acceptable if considered in remission and recurrence has been excluded by advanced imaging and biopsy within 6 months of enrollment.
- •Suspected perforation of gastrointestinal tract
- •Inability to pass guidewire across stricture
- •Active systemic infection
- •Allergy to paclitaxel or structurally related compounds
- •Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure
- •Chronic systemic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use
- •Received steroid injections into target stricture in the last 8 weeks.
- •Stricture not amenable to endoscopic dilation to ≥ 18 mm in the opinion of the investigator
- •Current use of nasal or oral feeding tube unless tube is removed prior to baseline assessments and subject maintains normal swallowing function.
- •Acute stricture condition that requires emergent procedure (e.g. immediate dilation)
- •Stricture complicated with abscess, fistula, deep ulceration, perforation, leakage or varices, or thrombosis, etc
- •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, ongoing infection, etc
- •Current participation in another pre-market drug or medical device clinical study that has not reached it's primary endpoint.
- •Dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (IEM), hypertensive lower esophageal sphincter, esophageal outlet obstruction, etc.
- •Active erosive esophagitis with a Los Angeles classification of Grade B-D at the time of endoscopy.
- •Significant esophageal dilation proximal to the stricture that, in the Investigator's opinion, may impact long-term esophageal motility.
- •Intolerant to effective acid suppression medication (e.g. proton pump inhibitors, H2 receptor antagonists)
- •Concurrent gastric and/or duodenal obstruction
结局指标
主要结局
Treatment Success
时间窗: 6 Months Post-Procedure
1\. The primary efficacy endpoint is freedom from stricture recurrence, measured as the time from Index procedure until stricture recurrence through 6 months post-procedure. Stricture recurrence is defined as an esophageal diameter \<13mm as measured using a functional luminal imaging probe, or clinically driven reintervention at the treated area within 6 months post-procedure as determined by the Clinical Events Committee
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
- Annualized Rate of Reintervention(Annually)
- Diameter Improvement at 6 months(6 Months Post-Procedure)
- Clinical Responder Rate at 6 months(6 Months Post-Procedure)
- Freedom from clinically driven target stricture reintervention through 6 months post-procedure(6 Months Post-Procedure)
- Freedom from symptom recurrence through 6 months post-procedure(6 Months Post-Procedure)
研究者
研究点 (68)
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