POISE I Pilot Study

Study Overview
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Brief Summary
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POISE I study is a feasibility study for evaluating the safety and efficacy of DCB.

Detailed Description
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The study is designed to determine the safety and effectiveness for drug coated balloon (DCB) for treating intestinal strictures. Up to 15 subjects are planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.

Official Title
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Paclitaxel-Coated Balloon for the Treatment of Symptomatic Recurrent Benign Intestinal Stricture

Conditions
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Intestinal Stricture

Intervention / Treatment
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* Combination Product: GIE Medical Drug Coated Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 and ≤ 80 years. Subjects for whom the balloon dilation would be chosen in standard practice, and the scope could not pass stricture. Recurrent to plain balloon dilation with at least 2 previous balloon dilation or stricturotomy sessions and recurrence of intestine obstructive symptoms/signs. Symptoms of intestinal partial occlusion Length of stenosis/stricture ≤ 7 cm Up to 2 discrete strictures. Ability to undergo periodic endoscopic follow-up. Voluntary participation and provided written informed consent. Exclusion Criteria: Pregnancy or breastfeeding or plan to get pregnant in next 12 months. Contraindication to endoscopy, anesthesia or deep sedation. Malignant bowel stricture. Extrinsic benign bowel stricture due to adhesion. Stricture complicated with abscess, fistula, ulceration or associated with mesenteric vessel thrombosis More than 2 stenosis/stricture lesions. Length of stenosis/stricture > 7 cm. Stricture not accessible by endoscopy. Suspected perforation of the gastrointestinal tract Acute bowel obstruction requiring urgent surgical intervention Low rectal or anal strictures Severe coagulation disorders (platelets < 70000; INR > 1.8). Active systemic infection Allergy to paclitaxel or any components of the delivery system. Life expectancy of less than 12 months. Drug abuse or on chronic steroid therapy for comorbidities. Unwilling or unable to comply with the follow-up study requirements. Lacking capacity to provide informed consent. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety. Currently participation in another pre-market drug or medical device clinical study. Chronic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use. Currently requiring abdominal radiation therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCB Treatment<br>Stricture patients treated by DCB | Combination Product: GIE Medical Drug Coated Balloon<br>* Stricture patients treated by DCB<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident of serious balloon dilation-related complications | Perforation, bleeding requiring endoscopic or surgical interventions or blood transfusion, severe abdominal pain requiring medications, infection requiring hospitalization or IV antibiotics | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure success | defined as subjects who were treated with GIE DCB achieved at least one scale improvement of the Endoscopic Obstructive Scale (EOS). | 6 months | 
| Percent subjects with improvement in Endoscopic Obstructive Scale (EOS) | Analyzed by 1, 2, or 3 scale improvement. | 6 months | 
| Change in obstructive symptoms using the Obstructive Symptom Score (OSS). | The Obstructive Symptom Score (OSS) is a composite measure of the total number of days of obstructive abdominal pain and the severity over a fourteen-day period using a 5-point Likert scale. (1=no pain, 2=mild, 3=moderate, 4=severe, 5=unbearable). | 30 days, 3 months, 6 months, and 12 months | 
| Number of repeated stricture dilation procedures | Repeat dilation for stricture recurrence | 30 days, 3 months, 6 months, and 12 months | 
| Procedural technical success | Successful endoscopic passage followed by successful delivery of the drug-coated balloon to the stricture area without resistance, inflated balloon to the defined diameter, DCB withdraw after deflating balloon without device malfunction. | Time of procedure |