Chronic Benign Bowel Stricture - Brooklyn NY

Summary:

What is the purpose of the research study?

The purpose of this study is to assess the safety and efficacy of the ProTractX3 Drug-Coated Balloon for the treatment of benign stricture in the bowel.

What is the ProTractX3, and how is it used?

Endoscopic  Balloon dilation treatment with ProTractX3 Drug-Coated Balloon is a simple outpatient procedure that combines balloon dilation to open the bowel and drug delivery designed to maintain symptom relief. The investigational treatment takes about fifteen minutes and is done on an outpatient basis.

Early results from the POISE study indicate that average symptoms improved after treatment with ProTractX3 Drug-Coated Balloon, and no patient required repeat dilation through 2 years of follow-up.

Potential Benefit of the ProTractX3:

• Improvement in obstructive symptoms and extended duration between treatments and recurrence of these symptoms.
• Simple outpatient therapy 

Patients may be able to participate in the study if they:

• are 22 years of age or older
• have a current diagnosis of symptomatic bowel stricture 
• have had at least two previous bowel stricture dilations
• are willing to undergo a medical procedure for their current bowel stricture 
• are willing to participate in the study and complete all study follow-up visits

Qualified Participants May Receive:

The Qualified participant will be paid a small stipend to cover the cost of time and travel for study visits. The stipend for each visit is described below:

1. Baseline: $150
2. Procedure: $200
3. 30 Days: $150
4. 3 months: $150
5. 6 months: $200
6. 12 months: $200 
7. 2-5 years: $150

You will be paid following each completed visit.