POISE I Pilot Study

Not Applicable

Active, not recruiting

• Conditions: Intestinal Stricture
• Interventions: Combination Product: GIE Medical Drug Coated Balloon

• Registration Number: NCT03886324
• Lead Sponsor: GIE Medical

Brief Summary

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

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 Timeline

• Study Start: 2019-02-25
• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-22
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-17
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DCB Treatment	GIE Medical Drug Coated Balloon	Stricture patients treated by DCB

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in obstructive symptoms using the Obstructive Symptom Score (OSS).	30 days, 3 months, 6 months, and 12 months	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).
Procedural technical success	Time of procedure	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.
Percent subjects with improvement in Endoscopic Obstructive Scale (EOS)	6 months	Analyzed by 1, 2, or 3 scale improvement.
Number of repeated stricture dilation procedures	30 days, 3 months, 6 months, and 12 months	Repeat dilation for stricture recurrence
Procedure success	6 months	defined as subjects who were treated with GIE DCB achieved at least one scale improvement of the Endoscopic Obstructive Scale (EOS).

Trial Locations

Locations (1)

Adventista Hospital; 🇵🇾 Asunción, Paraguay