Ureteric strictures are caused by scar-related narrowing of the ureter and may occur following ureteroscopy for stone disease, urologic or pelvic surgery, renal transplantation, radiation therapy, infection, or trauma. Untreated strictures may result in pain, hydronephrosis, recurrent infection, and deterioration of renal function.
The Optilume DCB is a cystoscope-compatible balloon catheter coated with paclitaxel, an antiproliferative agent intended to limit scar tissue formation following dilation. The device is approved and commonly used in elsewhere in the body.
While Optilume DCB is FDA-approved for certain urethral stricture indications, its use in the ureter is investigational and is being studied under an IDE in ENDURE 1.
Study Design Highlights include a prospective, non-randomized, multi-center feasibility design; planned enrollment of up to 60 adult subjects at up to 10 U.S. sites; and follow-up through five years after ureteral stent removal.
Patients may be eligible if they are 18 years of age or older, have a single benign ureteric or uretero-enteric stricture ≤4.0 cm, have two functioning kidneys, and are able to comply with required follow-up. Final eligibility is determined by a participating investigational site.
