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Mechanically-Manipulated Transrectal Ultrasound (TRUS) During Robotic-Assisted Laparoscopic Prostatectomy (RALP)


N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Mechanically-Manipulated Transrectal Ultrasound (TRUS) During Robotic-Assisted Laparoscopic Prostatectomy (RALP)


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Number of patients who have negative margins when a TRUS probe is used during RALP procedure without introducing additional complications.

Outcome Time Frame:

7 days post-RALP

Safety Issue:

No

Principal Investigator

Osamu Ukimura

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

4P-10-9

NCT ID:

NCT01495130

Start Date:

October 2011

Completion Date:

December 2012

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800