Clinical trial NCT03886324: POISE I Pilot Study
Official title: Paclitaxel-Coated Balloon for the Treatment of Symptomatic Recurrent Benign Intestinal Stricture
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Intestinal Stricture
Lead sponsor: GIE Medical
Sponsor class: INDUSTRY
First posted: 2019-03-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incident of serious balloon dilation-related complications
timeFrame: 30 days
Secondary outcomes:
measure: Procedure success
timeFrame: 6 months
measure: Percent subjects with improvement in Endoscopic Obstructive Scale (EOS)
timeFrame: 6 months
measure: Change in obstructive symptoms using the Obstructive Symptom Score (OSS).
timeFrame: 30 days, 3 months, 6 months, and 12 months
measure: Number of repeated stricture dilation procedures
timeFrame: 30 days, 3 months, 6 months, and 12 months
measure: Procedural technical success
timeFrame: Time of procedure
Other outcomes:
Locations:
city: Asunción
country: Paraguay
facility: Adventista Hospital
Study officials:
affiliation: The Cleveland Clinic
name: Bo Shen, MD
role: PRINCIPAL_INVESTIGATOR
References: