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Loop Resectoscope in Treating Patients With Bladder Cancer or Benign Prostatic Hyperplasia Who Are Undergoing Transurethral Resection

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: March 15, 2006
Last updated: March 25, 2013
Last verified: June 2007

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.

Condition Intervention
Bladder Cancer Procedure: biopsy Procedure: therapeutic conventional surgery

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Quality Assessment of the Roei Loop Resectoscope for Transurethral Resection of Bladder Neoplasm and BPH

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Surgeon satisfaction with usage of Roei loop resectoscope measured by a questionnaire after the surgical procedure

Estimated Enrollment: 24
Study Start Date: August 2005
Study Completion Date: June 2007
Detailed Description:


  • 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of bladder cancer or benign prostatic hyperplasia


  • Not specified


  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00303654

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Roei Medical Technologies Ltd.
Study Chair: Allan Pantuck, MD Jonsson Comprehensive Cancer Center
  More Information Identifier: NCT00303654     History of Changes
Other Study ID Numbers: CDR0000446284
Study First Received: March 15, 2006
Last Updated: March 25, 2013

Keywords provided by National Cancer Institute (NCI):
recurrent bladder cancer
stage I bladder cancer
stage II bladder cancer
stage III bladder cancer
stage IV bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Prostatic Hyperplasia
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Prostatic Diseases
Genital Diseases, Male processed this record on September 19, 2017