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NCT00956904 · ClinicalTrials.gov registry record · Early Phase 1
Ultrasound-Guided Navigation in Robot-Assisted Laparoscopic Radical Prostatectomy
A Early Phase 1 study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 50
- Enrollment target
NCT00956904: Clinical Trial Early Phase 1 study, sponsored by Johns Hopkins University.
NCT00956904 is a Early Phase 1 study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00956904, a Early Phase 1 study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 50 participants
- Enrollment target
Study 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..
Interventions
- DEVICE 3-D TRUS navigation software during T-RALP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2009-08 |
| Est. Completion | 2013-06 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00956904
The ClinicalTrials.gov registry entry for NCT00956904 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 3-D TRUS navigation software during T-RALP is the first listed.
NCT00956904 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00956904 about?
NCT00956904 is a clinical study titled "Ultrasound-Guided Navigation in Robot-Assisted Laparoscopic Radical Prostatectomy". 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...
What is the current status of trial NCT00956904?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 50 participants. The study started on 2009-08. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00956904?
The interventions under investigation include: 3-D TRUS navigation software during T-RALP (DEVICE).
Who is sponsoring clinical trial NCT00956904?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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