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

Launched by GIE MEDICAL · Sep 27, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called the ProTractX3™ TTS DCB, which is a special balloon coated with medication, designed to help patients with a condition known as benign bowel stricture. This means that some patients have areas in their intestines that are too narrow, causing symptoms like pain or difficulty digesting food. The goal of the trial is to see if this new treatment is safe and effective for people who have had this problem before and have already undergone at least two other procedures to widen the stricture.

To be eligible for this trial, participants need to be at least 22 years old and must have a diagnosis of a symptomatic benign bowel stricture that hasn’t responded well to previous treatments. Participants should be willing to follow the study guidelines and provide consent. However, there are some important exclusions, such as being pregnant, having certain serious health conditions, or having a type of stricture that cannot be treated with the balloon. If you join this trial, you can expect to receive the new treatment and will be monitored closely afterward to see how well it works and if there are any side effects.

Gender

ALL

Eligibility criteria

• 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, 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 \>10%, affected (inflamed) surface \>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 ≤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 ≥15mm in small bowel or ≥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
• • 19. 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.
• • 20. Current participation in another pre-market drug or medical device clinical study unless in long term follow-up