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

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ClinicalTrials.gov Identifier: NCT00303654
Recruitment Status : Completed
First Posted : March 17, 2006
Last Update Posted : March 26, 2013
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment
Bladder Cancer Procedure: biopsy Procedure: therapeutic conventional surgery

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Quality Assessment of the Roei Loop Resectoscope for Transurethral Resection of Bladder Neoplasm and BPH
Study Start Date : August 2005
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

DISEASE CHARACTERISTICS:

  • Diagnosis of bladder cancer or benign prostatic hyperplasia

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303654


Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Roei Medical Technologies Ltd.
Investigators
Study Chair: Allan Pantuck, MD Jonsson Comprehensive Cancer Center
More Information

ClinicalTrials.gov Identifier: NCT00303654     History of Changes
Other Study ID Numbers: CDR0000446284
UCLA-0506127-01
First Posted: March 17, 2006    Key Record Dates
Last Update Posted: March 26, 2013
Last Verified: June 2007

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
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Prostatic Diseases
Genital Diseases, Male