Transrectal Ultrasound (TRUS) in Finding Tumors During Robotic-Assisted Laparoscopic Surgery

NCT ID: NCT01495130

Last Updated: 2014-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-12-31

Brief Summary

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This pilot clinical trial studies mechanically-manipulated ultrasound in finding tumors during robotic-assisted surgery in patients with prostate cancer. Diagnostic procedures, such as ultrasound, may help find prostate cancer and find out how far the disease has spread during surgery

Detailed Description

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PRIMARY OBJECTIVES: I. To assess the feasibility and limitations of using a mechanically-manipulated transrectal ultrasound (TRUS) probe for TRUS evaluation during a da Vinci robotic-assisted laparoscopic prostatectomy (RALP). II. To collect TRUS evaluation data during RALP to guide us in deciding whether and how the mechanical manipulation of the TRUS probe will allow sufficient clarity of ultrasound imaging. OUTLINE: Patients undergo TRUS during RALP. After the completion of study treatment, patients are followed up at 7 days.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (TRUS)

Patients undergo TRUS during RALP.

Group Type EXPERIMENTAL

ultrasound imaging

Intervention Type PROCEDURE

Undergo transrectal ultrasound

robot-assisted laparoscopic surgery

Intervention Type PROCEDURE

Undergo robotic-assisted laparoscopic prostatectomy

Interventions

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ultrasound imaging

Undergo transrectal ultrasound

Intervention Type PROCEDURE

robot-assisted laparoscopic surgery

Undergo robotic-assisted laparoscopic prostatectomy

Intervention Type PROCEDURE

Other Intervention Names

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ultrasonography ultrasound ultrasound test

Eligibility Criteria

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Inclusion Criteria

* Undergoing Robotic Assisted Laparoscopic Prostatectomy

Exclusion Criteria

* Known or discovered rectal pathology
* Bleeding hemorrhoids
* Rectal stenosis
* Any prior rectal surgeries
* Prior rectal radiation
* Any known rectal disease
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Osamu Ukimura

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2011-03570

Identifier Type: REGISTRY

Identifier Source: secondary_id

4P-10-9

Identifier Type: -

Identifier Source: org_study_id

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