Quality Assessment of the Roei Loop Resectoscope for Transurethral Resection of Bladder Neoplasm and BPH
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bladder Cancer
- Sponsor
- Roei Medical Technologies Ltd.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Surgeon satisfaction with usage of Roei loop resectoscope measured by a questionnaire after the surgical procedure
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Surgeon satisfaction with usage of Roei loop resectoscope measured by a questionnaire after the surgical procedure