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

Обзор

To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.

Вмешательства

• Комбинированный продукт GIE Medical ProTractX3 TTS DCB
  The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
• Другое Control
  Standard of Care Endoscopic Dilation

Первичные конечные точки

• Freedom from Stricture Recurrence [Срок оценки: 6 Months Post-Treatment]
• Primary Safety Outcome [Срок оценки: 30 Days Post-Treatment]

Вторичные конечные точки (2)

• Freedom from clinically driven target stricture reintervention [Срок оценки: 6 Months Post-Procedure]
• Improvement in GIQLI-10 score [Срок оценки: 6 Months Post-Procedure]

Критерии участия

Критерии включения

• Age ≥ 22
• 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

Критерии исключения

• 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

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 · 33 центра

• 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
• Borland-Groover — Jacksonville
• … и ещё 25 центров

Идентификаторы

NCT: NCT05561127 · PR2053

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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