Intestinal Stricture
Conditions
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.
Interventions
COMBINATION_PRODUCTGIE Medical Drug Coated Balloon
Stricture patients treated by DCB
Sponsors
GIE Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Percent subjects with improvement in Endoscopic Obstructive Scale (EOS) | 6 months | Analyzed by 1, 2, or 3 scale improvement. |
| 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). |
| Number of repeated stricture dilation procedures | 30 days, 3 months, 6 months, and 12 months | Repeat dilation for stricture recurrence |
| 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. |
Countries
Paraguay
Outcome results
None listed