POISE I Pilot Study

NCT ID: NCT03886324

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-25
• Study Completion Date: 2025-12-31

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.

Conditions

Intestinal Stricture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DCB Treatment

Stricture patients treated by DCB

Group Type: EXPERIMENTAL

GIE Medical Drug Coated Balloon

Intervention Type: COMBINATION_PRODUCT

Stricture patients treated by DCB

Interventions

GIE Medical Drug Coated Balloon

Stricture patients treated by DCB

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GIE Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bo Shen, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Adventista Hospital

Asunción, , Paraguay

Countries

Paraguay

Other Identifiers

PR2002

Identifier Type: -

Identifier Source: org_study_id