Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel (PATENT-B)

This is an interventional treatment trial for Bowel; Stricture focused on measuring dcb, bowel stricture, drug coated balloon, paclitaxel coated balloon Read More

Inclusion Criteria:

1. Age ≥ 22
2. Diagnosis of symptomatic benign bowel stricture with at least 2 previous dilations.
3. Willing and able to complete protocol required follow up
4. Willing and able to provide written informed consent
5. Stricture length ≤ 5 cm

Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding or plan to get pregnant in next 12 months
2. Contraindication to endoscopy, anesthesia, or deep sedation.
3. Suspicion of malignant bowel stricture NOTE: Biopsy should be taken for every stricture during the initial endoscopy, however endoscopic balloon dilation may proceed without awaiting results if suspicion for malignancy is low in the opinion of the investigator.
4. Benign stricture due to extrinsic compression
5. Stricture is not amenable to standard balloon dilation (e.g. severe angulation, unable to pass guidewire, etc.)
6. Stricture complicated with abscess, fistula, deep ulceration, perforation, leakage or varices
7. Multiple clinically significant strictures separated by greater than 5 cm
8. Received steroid injections into target stricture in the last 4 weeks
9. Stricture is not able to be dilated to ≥12mm in small bowel or ≥15mm in large bowel
10. Diagnosis of metastatic cancer of any type that is not considered in remission or non-metastatic cancer that may require radiation treatment in the pelvic region (e.g. prostate cancer)
11. Suspected perforation of gastrointestinal tract
12. Active systemic infection
13. Allergy to paclitaxel
14. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per relevant societal guidelines
15. Chronic systemic steroid use (defined as greater than 10 mg/day) for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use
16. Condition requiring treatment in urgent setting
17. Life expectancy of less than 24 months
18. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety, such as recent myocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracic aneurysm, pharyngeal or cervical deformity, etc.
19. Current participation in another pre-market drug or medical device clinical study unless in long term follow-up