Enter your ZIP code:

Please enter a 5 digit zipcode
No results...

Entering your zip code helps us to provide information and results that are more relevant to you.

Your privacy is important to us. By continuing, you agree to our Privacy Policy.





Paclitaxel Coated balloon for the Treatment of chronic bEnigN sTricture- Bowel

Gastroenterology, Surgery
Jason Samarasena
Paclitaxel Coated balloon for the Treatment of chronic bEnigN sTricture- Bowel
Digestive - Gastrointestinal

Study Description

Eligibility

  1. Age greater than or equal to 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 less than or equal to 5 cm
  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, perforation, leakage or varices
  7. Stricture segment has moderate to severe active inflammation at the time of treatment. Moderate to severe inflammation is defined as any one of; ulcers >0.5cm in diameter, ulcerated surface greater than 10%, affected (inflamed) surface greater than 50%, marked erythema, absent vascular pattern, significant friability, or erosions
  8. Multiple clinically significant strictures unable to be treated with a single balloon (i.e. total segment length must be less than or equal to 5cm) NOTE: Clinically significant strictures 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 greater than or equal to 15mm in small bowel or greater than or equal to 18mm in large bowel
  11. 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)
  12. Suspected perforation of gastrointestinal tract
  13. Active systemic infection
  14. Allergy to paclitaxel
  15. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per relevant societal guidelines
  16. 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
  17. Condition requiring treatment in urgent setting

18, Life expectancy of less than 24 months

  1. 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.
  2. Current participation in another pre-market drug or medical device clinical study unless in long term follow-up
A female nurse attentively holds a tablet, ready to assist with patient care and medical information.

Interested in Participating in this Trial?

Thank you for your interest with our team.

One of our specialists will be in contact with you soon.