POISE I Pilot Study (POISE)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Intestinal Stricture
• Intervention / Treatment: Combination product: GIE Medical Drug Coated Balloon

Detailed Description

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
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Paraguay
  • Asunción, Paraguay
    • Adventista Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DCB Treatment; Stricture patients treated by DCB	Combination product: GIE Medical Drug Coated Balloon; Stricture patients treated by DCB

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GIE Medical
• Investigators: Principal Investigator: Bo Shen, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2019
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: PR2002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No