Trial Information

Quality Assessment of the Roei Loop Resectoscope for Transurethral Resection of Bladder Neoplasm and BPH

OBJECTIVES:

- Determine the efficacy, in terms of mechanical capabilities, of the Roei loop
resectoscope in patients with bladder cancer or benign prostatic hyperplasia undergoing
transurethral resection of bladder tumor or benign prostatic adenoma.

- Determine the quality of specimens submitted for histological analysis from patients
undergoing this procedure.

OUTLINE: This is an open-label, pilot study.

Patients undergo transurethral resection using the Roei loop resectoscope. Surgeon
satisfaction with the Roei loop resectoscope is measured by a self-assessment questionnaire.
The quality of specimens submitted for histological study are also assessed.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.