POISE I Pilot Study

Intestinal Stricture Clinical Trial

— POISE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03886324
• Other study ID #: PR2002
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: December 2025

Study information

• Verified date: August 2022
• Source: GIE Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Intestinal Stricture

Intervention

Combination Product:
• GIE Medical Drug Coated Balloon
Stricture patients treated by DCB

Locations

Country	Name	City	State
Paraguay	Adventista Hospital	Asunción

Sponsors (1)

Lead Sponsor	Collaborator
GIE Medical

Country where clinical trial is conducted

Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Percent subjects with improvement in Endoscopic Obstructive Scale (EOS)	Analyzed by 1, 2, or 3 scale improvement.	6 months
Secondary	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
Secondary	Number of repeated stricture dilation procedures	Repeat dilation for stricture recurrence	30 days, 3 months, 6 months, and 12 months
Secondary	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