Patent-E

The primary objective of this study is to evaluate the safety and efficacy of the ProTractX3 DCB for the treatment of benign esophageal strictures. The ProTractX3 DCB is intended to treat benign strictures of the alimentary tract, combining mechanical dilation with localized delivery of the drug paclitaxel. The ProTractX3 DCB system combines the procedural simplicity of balloon dilation with improved efficacy over standard dilation through its localized application of paclitaxel to prevent future cellular proliferation and excessive scar tissue generation during the healing process. The goal of this technology is to provide immediate relief via balloon dilation and create lasting durable results. The primary safety endpoint is the incidence of device- and/or procedure-related Major Adverse Events (MAEs) through 30 days post-procedure, for which an MAE is defined as a composite of any of the following complications: death, perforation of the GI tract, or bleeding requiring intervention or transfusion. The primary efficacy endpoint is treatment success through 6 months post-treatment, for which treatment success is defined as an Ogilvie Dysphagia Score 1 without clinically driven repeat intervention. Hypothesis-Tested Secondary Endpoints 1. Freedom from symptom recurrence through 6 months post-procedure 2. Freedom from clinically driven reintervention through 6 months post-procedure
3. Esophageal diameter 13mm at 6 months post-procedure Ancillary Endpoints
4. Technical Success
5. Improvement in Ogilvie Dysphagia Score at each follow-up 6. Improvement in Dysphagia Handicap Index score at each follow-up 7. Minimum esophageal stricture diameter through follow-up 8. Number of esophageal dilation procedures through each follow up
9. Freedom from clinically driven reintervention through each follow-up
10. Freedom from symptom recurrence through each follow-up 11. VAS for pain scores at each follow-up 12. Composite EQ-5D quality of life scores at each follow-up

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Medical Research
• Age: - 99 Years
• Gender: All