To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
198
Paclitaxel Coated Balloon
Standard Endoscopic Dilation
Treatment Success
1\. The primary efficacy endpoint is freedom from stricture recurrence, measured as the time from Index procedure until stricture recurrence through 6 months post-procedure. Stricture recurrence is defined as an esophageal diameter \<13mm as measured using a functional luminal imaging probe, or clinically driven reintervention at the treated area within 6 months post-procedure as determined by the Clinical Events Committee
Time frame: 6 Months Post-Procedure
Primary Safety Outcome
Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion)
Time frame: 30 Days Post-Treatment
Annualized Rate of Reintervention
The annualized reintervention rate is defined as the annualized number of clinically driven interventions and will be assessed by comparing the annualized rate per patient year between groups using a test of Poisson rates.
Time frame: Annually
Diameter Improvement at 6 months
The minimum esophageal stricture diameter will be assessed by a functional luminal imaging probe (EndoFLIP) during endoscopy and compared between the Test and Control arms. The minimum esophageal stricture diameter will be measured at baseline and during the 6-month follow-up, or at the time of a reintervention if one occurs prior to 6 months.
Time frame: 6 Months Post-Procedure
Clinical Responder Rate at 6 months
Time frame: 6 Months Post-Procedure
Freedom from clinically driven target stricture reintervention through 6 months post-procedure
Time frame: 6 Months Post-Procedure
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Birmingham Gastroenterology Associates
Birmingham, Alabama, United States
NOT_YET_RECRUITINGHonor Health
Scottsdale, Arizona, United States
RECRUITINGUniversity of California, Irvine
Irvine, California, United States
RECRUITINGGastro Care Institute
Lancaster, California, United States
RECRUITINGCedars Sinai
Los Angeles, California, United States
RECRUITINGSan Diego Gastroenterology
San Diego, California, United States
RECRUITINGUniversity of Colorado Anschutz
Aurora, Colorado, United States
RECRUITINGUniversity of Florida
Gainesville, Florida, United States
RECRUITINGBorland-Groover
Jacksonville, Florida, United States
RECRUITINGResearch Associates of South Florida
Miami, Florida, United States
RECRUITING...and 24 more locations
Freedom from symptom recurrence through 6 months post-procedure
Time frame: 6 Months Post-Procedure