Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel

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 12months

2. Contraindication to endoscopy, anesthesia, or deep sedation.

3. Suspicion of malignant bowel stricture NOTE: Biopsy should be taken for everystricture during the initial endoscopy, however endoscopic balloon dilation mayproceed without awaiting results if suspicion for malignancy is low in the opinionof 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, perforation, leakage or varices

7. Stricture segment has moderate to severe active inflammation at the time oftreatment. Moderate to severe inflammation is defined as any one of; ulcers >0.5cmin diameter, ulcerated surface >10%, affected (inflamed) surface >50%, markederythema, absent vascular pattern, significant friability, or erosions

8. Multiple clinically significant strictures unable to be treated with a singleballoon (i.e. total segment length must be ≤5cm) NOTE: Clinically significantstrictures include those that are unable to be passed by the endoscope.

9. Received steroid injections into target stricture in the last 8 weeks

10. Stricture is not able to be dilated to ≥15mm in small bowel or ≥18mm in large bowel

11. Diagnosis of metastatic cancer of any type that is not considered in remission ornon-metastatic cancer that may require radiation treatment in the pelvic region (e.g. prostate cancer)

12. Suspected perforation of gastrointestinal tract

13. Active systemic infection

14. Allergy to paclitaxel

15. Severe coagulation disorders or current use of anticoagulant or antiplateletmedication that cannot be safely managed per relevant societal guidelines

16. Chronic systemic steroid use (defined as greater than 10 mg/day) for any medicalconditions unless subject is willing to undergo a 4-week washout and discontinuesteroid use

17. Condition requiring treatment in urgent setting

18. Life expectancy of less than 24 months

19. Concurrent medical condition that would affect the investigator's ability toevaluate the patient's condition or could compromise patient safety, such as recentmyocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracicaneurysm, pharyngeal or cervical deformity, etc.

20. Current participation in another pre-market drug or medical device clinical studyunless in long term follow-up