Ultrasound-Guided Navigation in Robot-Assisted Laparoscopic Radical Prostatectomy

Stopped early · Early Phase 1

Conditions studied: Prostate Cancer

In brief

A new solution for guiding the surgeon in robot-assisted laparoscopic radical prostatectomy (RALP) is image-guided navigation using transrectal ultrasound (TRUS). A TRUS-guided intraoperative navigation system using a robotic ultrasound probe manipulator (TRUS Robot) has been developed. The proposed research is a pilot clinical trial of the TRUS Robot and three-dimensional (3-D) navigation software to test its image-guidance ability of helping the surgeon during RALP. This is a dual robot approach, a Tandem-RALP (T-RALP). The TRUS Robot allows a steady holding as well as remote manipulation of the TRUS probe. In addition, the TRUS Robot can track the accurate position of TRUS probe which allows 3-D reconstruction of the images. While the intraoperative TRUS findings will not be used in surgical decision making in this trial, the use of TRUS imaging during radical prostatectomy can potentially improve the visualization of the NVB and subsequently improve postoperative recovery of potency in men. In addition, the 3-D reconstruction images of the prostate gland can potentially provide clear and accurate guidance of surgical landmarks to the surgeon..

Key facts

Study ID: NCT00956904
Run by: Johns Hopkins University
People needed: 50
Starts: 2009-08-01
Expected to finish: 2013-06-01
Last updated by the study team: 2013-06-19

Who can join

Age: 35 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Patients must be scheduled for a robotic LRP
Patients must be between the ages of 35 and 75
Patients must not have one of the listed exclusion criteria
Patients must be able to understand and willing to adhere to the study protocol
Patients must have a clinical stage diagnosis of T1 or T2
Patients must have a preoperative serum PSA < 20ng/ml
Patients must have a biopsy Gleason score of 5-8

You may not qualify if…

Patients less than 35 years of age and over 75 years of age.
Patients with previous rectal surgery
Patients with anal stenosis that prevents the TRUS probe insertion
Patients with extensive abdominal surgery
Patients with inadequate bowel prep
Patients who are unwilling or unable to sign informed consent
Patients on anticoagulation medication (eg. coumadin, lovenox, or heparin)
Patients with a clinical stage diagnosis of T3 - Patients with a preoperative serum PSA ≥ 20 ng/mL
Patients with a biopsy Gleason score < 5 or > 8

Where it is running

Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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