To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
171
The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
Standard of Care Endoscopic Dilation
Freedom from Stricture Recurrence
Endoscopic Obstruction Scale (EOS) of \> 1 when using a pediatric colonoscope or equivalent
Time frame: 6 Months Post-Treatment
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
Freedom from clinically driven target stricture reintervention
Freedom from clinically driven reintervention represents freedom from repeat dilation, incision, or surgical management of the target stricture for recurrent obstructive symptoms.
Time frame: 6 Months Post-Procedure
Improvement in GIQLI-10 score
The Gastrointestinal Quality of Life Index (GIQLI) is a validated questionnaire developed as a health-related quality of life assessment tool for patients with gastrointestinal diseases. The items on the GIQLI-10 align closely with common obstructive symptoms found in patients with bowel strictures.
Time frame: 6 Months Post-Procedure
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Honor 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
RECRUITINGHillcrest Medical Research
Orange City, Florida, United States
NOT_YET_RECRUITING...and 23 more locations