POISE I Pilot Study

GIE Medical10 enrolled

Overview

POISE I study is a feasibility study for evaluating the safety and efficacy of DCB.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Intestinal Stricture

Interventions

GIE Medical Drug Coated BalloonCOMBINATION_PRODUCT

Stricture patients treated by DCB

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 and ≤ 80 years. 2. Subjects for whom the balloon dilation would be chosen in standard practice, and the scope could not pass stricture. 3. Recurrent to plain balloon dilation with at least 2 previous balloon dilation or stricturotomy sessions and recurrence of intestine obstructive symptoms/signs. 4. Symptoms of intestinal partial occlusion 5. Length of stenosis/stricture ≤ 7 cm 6. Up to 2 discrete strictures. 7. Ability to undergo periodic endoscopic follow-up. 8. Voluntary participation and provided written informed consent. Exclusion Criteria: 1. Pregnancy or breastfeeding or plan to get pregnant in next 12 months. 2. Contraindication to endoscopy, anesthesia or deep sedation. 3. Malignant bowel stricture. 4. Extrinsic benign bowel stricture due to adhesion. 5. Stricture complicated with abscess, fistula, ulceration or associated with mesenteric vessel thrombosis 6. More than 2 stenosis/stricture lesions. 7. Length of stenosis/stricture \> 7 cm. 8. Stricture not accessible by endoscopy. 9. Suspected perforation of the gastrointestinal tract 10. Acute bowel obstruction requiring urgent surgical intervention 11. Low rectal or anal strictures 12. Severe coagulation disorders (platelets \< 70000; INR \> 1.8). 13. Active systemic infection 14. Allergy to paclitaxel or any components of the delivery system. 15. Life expectancy of less than 12 months. 16. Drug abuse or on chronic steroid therapy for comorbidities. 17. Unwilling or unable to comply with the follow-up study requirements. 18. Lacking capacity to provide informed consent. 19. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety. 20. Currently participation in another pre-market drug or medical device clinical study. 21. Chronic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use. 22. Currently requiring abdominal radiation therapy

Locations (1)

Adventista Hospital

Asunción, Paraguay

Outcomes

Primary Outcomes

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

Time frame: 30 days

Secondary Outcomes

Procedure success

defined as subjects who were treated with GIE DCB achieved at least one scale improvement of the Endoscopic Obstructive Scale (EOS).

Time frame: 6 months

Percent subjects with improvement in Endoscopic Obstructive Scale (EOS)

Analyzed by 1, 2, or 3 scale improvement.

Time frame: 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).

Time frame: 30 days, 3 months, 6 months, and 12 months

Number of repeated stricture dilation procedures

Repeat dilation for stricture recurrence

Time frame: 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 frame: Time of procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.