POISE I Pilot Study

GIE Medical

Status: Active, not recruiting

Conditions: Intestinal Stricture

Treatments: Combination Product: GIE Medical Drug Coated Balloon

Study type: Interventional

Funder types: Industry

Identifiers

NCT03886324

PR2002

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

DCB Treatment

Experimental group

Description:

Stricture patients treated by DCB

Treatment:

Combination Product: GIE Medical Drug Coated Balloon