Bladder Cancer Clinical Trial
Official title:
Quality Assessment of the Roei Loop Resectoscope for Transurethral Resection of Bladder Neoplasm and BPH
RATIONALE: Transurethral resection is a less invasive type of surgery for bladder cancer or
benign prostatic hyperplasia. Transurethral resection using a loop resectoscope may have
fewer side effects and improve recovery.
PURPOSE: This clinical trial is studying how well the loop resectoscope works in treating
patients with bladder cancer or benign prostatic hyperplasia who are undergoing
transurethral resection.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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