Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus

Обзор

To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.

Вмешательства

• Комбинированный продукт GIE Medical ProTractX3 TTS DCB
  Paclitaxel Coated Balloon
• Другое Control
  Standard Endoscopic Dilation

Первичные конечные точки

• Treatment Success [Срок оценки: 6 Months Post-Procedure]
• Primary Safety Outcome [Срок оценки: 30 Days Post-Treatment]

Вторичные конечные точки (5)

• Annualized Rate of Reintervention [Срок оценки: Annually]
• Diameter Improvement at 6 months [Срок оценки: 6 Months Post-Procedure]
• Clinical Responder Rate at 6 months [Срок оценки: 6 Months Post-Procedure]
• Freedom from clinically driven target stricture reintervention through 6 months post-procedure [Срок оценки: 6 Months Post-Procedure]
• Freedom from symptom recurrence through 6 months post-procedure [Срок оценки: 6 Months Post-Procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 34 центра

• Birmingham Gastroenterology Associates — Birmingham
• Honor Health — Scottsdale
• University of California, Irvine — Irvine
• Gastro Care Institute — Lancaster
• Cedars Sinai — Los Angeles
• San Diego Gastroenterology — San Diego
• University of Colorado Anschutz — Aurora
• University of Florida — Gainesville
• … и ещё 26 центров

Идентификаторы

NCT: NCT05561114 · PR2052

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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