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


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Bladder Cancer

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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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of bladder cancer or benign prostatic hyperplasia

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Surgeon satisfaction with usage of Roei loop resectoscope measured by a questionnaire after the surgical procedure

Safety Issue:

No

Principal Investigator

Allan Pantuck, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000446284

NCT ID:

NCT00303654

Start Date:

August 2005

Completion Date:

June 2007

Related Keywords:

  • Bladder Cancer
  • recurrent bladder cancer
  • stage I bladder cancer
  • stage II bladder cancer
  • stage III bladder cancer
  • stage IV bladder cancer
  • Prostatic Hyperplasia
  • Urinary Bladder Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781