ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture … (NCT03499964) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
United States127 participantsStarted 2018-06-22
Plain-language summary
ROBUST III is a prospective, multi-center, randomized controlled adaptive sample size clinical trial to establish the safety and effectiveness for the Optilume Stricture Drug Coated Balloon (DCB).
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Male subjects ≥ 18 years' old
✓. Visual confirmation of stricture via cystoscopy or urethrogram
✓. Single, tandem or diffuse anterior urethral stricture(s), less than or equal to 3.0 cm total length measured by retrograde urethrogram. (Stricture length is defined as the distance between the most distal edge of the stricture to the most proximal edge of the stricture).
✓. Two or more prior dilation treatments of the same stricture, including DVIU (Direct Vision Internal Urethrotomy), but no prior urethroplasty.
✓. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent urinary tract infections (UTI's).
✓. International Prostrate Symptoms Score (IPSS) score of 11 or higher (assumed to be "35" if suprapubic catheter is present)
✓. Lumen diameter ≤ 12F by urethrogram
✓. Qmax \<15 ml/sec (assumed to be "0" if suprapubic catheter is present)
Exclusion criteria
✕. Subjects with diffuse stricture length, greater than 3.0 cm in total length. (Stricture length is defined as the distance between the most distal edge of the stricture to the most proximal edge of the stricture).
✕. Subjects with a history of hypersensitivity reactions to TAXOL, on medication that may have negative interaction with paclitaxel, with solid tumors who have a baseline neutrophil counts of \<1500 cells/mm3 or subjects with AIDS-related Kaposi's sarcoma with baseline neutrophile counts of \<1000 cells/mm3.
What they're measuring
1
Percentage of Subjects Stricture Free
Timeframe: 6 months
2
Safety: Rate of Major Device or Procedure Related Complications