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

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

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

Conditions
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Bowel; Stricture

Intervention / Treatment
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* Combination Product: GIE Medical ProTractX3 TTS DCB
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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, deep ulceration, perforation, leakage or varices Multiple clinically significant strictures separated by greater than 5 cm Received steroid injections into target stricture in the last 4 weeks Stricture is not able to be dilated to ≥12mm in small bowel or ≥15mm 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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GIE Medical ProTractX3 TTS DCB<br>The ProTractX3 Drug-coated balloon is a 0.035 guidewire compatible over-the-wire catheter. | Combination Product: GIE Medical ProTractX3 TTS DCB<br>* The ProTractX3 Drug-coated balloon is a 0.035 guidewire compatible over-the-wire catheter.<br>|
| Active Comparator: Control<br>Standard of Care. | Other: Control<br>* Standard of Care Endoscopic Dilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomic Success | Endoscopic Obstruction Scale (EOS) of ≤1 when using a pediatric colonoscope or equivalent (outer diameter 12mm ± 0.5mm) without clinically driven repeat intervention prior to the close of the 6-month window. | 6 Months Post-Treatment | 
| Primary Safety Outcome | Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion) | 30 Days Post-Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from clinically driven target stricture reintervention | Freedom from clinically driven reintervention represents freedom from repeat dilation, incision, or surgical management of the target stricture for recurrent obstructive symptoms. | 6 Months Post-Procedure | 
| Improvement in GIQLI-10 score | The Gastrointestinal Quality of Life Index (GIQLI) is a validated questionnaire developed as a health-related quality of life assessment tool for patients with gastrointestinal diseases. The items on the GIQLI-10 align closely with common obstructive symptoms found in patients with bowel strictures. | 6 Months Post-Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dcb, bowel stricture, drug coated balloon, paclitaxel coated balloon