Patent-B
Brief description of study
The primary objective is to determine the safety and efficacy of GIE Medicals ProTractX3 TTS DCB for the treatment of recurrent benign bowel 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 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 anatomic success through 6 months post-treatment, for which anatomic success is defined as an Endoscopic Obstruction Scale (EOS) of 1 when using a pediatric colonoscope or equivalent (outer diameter 12mm ± 0.5mm) without clinically driven repeat intervention prior to the close of the 6-month window. Hypothesis Tested Secondary Endpoints
1. Freedom from clinically driven target stricture reintervention through
6 months post-procedure
2. Improvement in GIQLI-10 score through 6 months post-procedure
Ancillary Endpoints
3. Surgery Free Survival at each follow-up
4. Improvement in GIQLI-10 score at each follow-up
5. Technical success
6. Improvement in EOS at each follow-up
7. Composite EQ-5D quality of life scores at each follow-up
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: - 99 Years
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Gender: All
TBD
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