Ultrasound-Guided Navigation in Robot-Assisted Laparoscopic Radical Prostatectomy

NCT00956904 | Terminated Early Phase 1 DMC

• 1 other identifier: NA_00027540
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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..

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Prostatectomy; Transrectal Ultrasound; Tandem RALP

Outcome Measures

Primary Outcomes (1)

• Accuracy of TRUS Robot and 3-D TRUS navigation software.

  To assess whether NVB localization is accurate using the TRUS Robot and 3-D TRUS navigation software during T-RALP \& can accurately locate and quantify the distance between anatomical landmarks.

  Measurements will be recorded in the time frame between the start of surgery to the end of surgery.

Secondary Outcomes (1)

• Safety of T-RALP

  Measurements determined by Dr. Han will be recorded in the time frame between the start of surgery to the end of surgery.

Study Arms (1)

3-D TRUS navigation software during T-RALP

EXPERIMENTAL

Device: 3-D TRUS navigation software during T-RALP

Interventions

3-D TRUS navigation software during T-RALP DEVICE

A new solution for guiding the surgeon in 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 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.

3-D TRUS navigation software during T-RALP

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be scheduled for a robotic LRP
• Patients must be between the ages of 35 and 75

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Misop Han, M.D., M.S.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 10, 2009
• First Posted: August 11, 2009
• Study Start: August 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

US (1)