PATENT B: Paclitaxel Coated balloon for the Treatment of chronic bEnigN sTricture Bowel
Sponsor: |
GIE Medical |
Enrolling: |
Male and Female Patients |
Study Length: |
5 Years |
Clinic Visits: |
10 |
IRB Number: |
AAAU3865 |
U.S. Govt. ID: |
NCT05561127 |
Contact: |
Claudia Musat: 212-342-4102 / surgcoreresearch@cumc.columbia.edu |
The purpose of this study is to assess the safety and effectiveness of GIE Medical's ProTractX3 TTS drug coated balloon (DCB) for the treatment of benign stricture in the bowel. This study is conducted to see whether this new drug coated balloon dilation device can treat strictures and reduce the rate of recurrence. Up to 215 subjects will participate in the main study at up to 30 sites in the United States. Participants in the study will be randomly assigned to receive study treatment with either the ProTractX3 DCB (study device), or a normal dilation. You are two times as likely to be randomly chosen to receive study treatment with the study device compared to the standard of care (2:1 randomization). The treatment procedure may be done on the same day as your screening or it might be done several days after. After study treatment, you are required to return to the clinic for four (4) follow-up visits in the first year (1, 3, 6 & 12 months) and one visit each year after that for eight visits after study treatment (up to 5 years).
Have you been diagnosed with bowel stricture with at least 2 previous dilations? |
Yes |
No |
Are you currently participating in another research study and currently receiving an experimental drug or device? |
Yes |
No |
Is your bowel stricture the result of cancer? |
Yes |
No |