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NCT00915031 · ClinicalTrials.gov registry record · NA
Use of Hypothermia During Robotic Prostatectomy
A NA study, sponsored by University of California, Irvine.
- Completed
- Registry status
- NA
- Development phase
- 738
- Enrollment target
NCT00915031: Completed NA study, sponsored by University of California, Irvine.
NCT00915031 is a NA study that has completed, run by University of California, Irvine. The registered enrollment target is 738 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00915031, a NA study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- NA
- Development phase
- 738 participants
- Enrollment target
Study Summary
Robotic assisted laparoscopic radical prostatectomy (RLP) has gained widespread acceptance as a standard treatment for clinically localized prostate cancer. Despite the enhanced visualization and precise dissection afforded by the robotic platform, two major comorbidities affect a significant number of men: incontinence and erectile function. Urinary continence and erectile function It is commonly believed that the most important factor affecting continence is preservation of the external urinary sphincter complex which lies just below the prostate. Trauma to the urethral tissue itself after it is transected from the prostate and damage to the autonomic nerves that control this sphincter may lead to sphincteric dysfunction. In addition, dissection of the bladder may lead to bladder irritability which also plays a role in incontinence. Surgical removal of the prostate also causes significant inflammatory damage to the pelvic floor which likely delays recovery of urinary continence. The same trauma issues apply to sexual function. One possible method to protect the nerves and other tissues from operative trauma may be the use of local hypothermia (cold-ischemia) to the pelvis. Local tissue hypothermia using ice, ice slush, or cold irrigation has been safely and routinely used for decades in humans during brain, heart, and kidney surgery to minimize organ damage. Yet, this technique has never been applied to prostate surgery. We will accomplish local cooling of the pelvis using a cooling balloon inserted into the rectum. The cooling balloon is powered by an FDA approved cooling system developed by Innercool therapies. Temperatures of 57-86 degrees F (22+/-8 degrees C).
Primary Outcome
The primary aim is confirmation of the feasibility and safety using an improved, more efficient and less labor intensive cooling balloon in patients undergoing hypothermic nerve-sparing RLP. Continence is defined as no protective urinary pad use as reported by the patient in response to the very first question on page 1 of the sample questionnaire.
Interventions
- DEVICE UroCool
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 738 participants |
| Start Date | 2009-08 |
| Est. Completion | 2015-06 |
| Phase | NA |
What the finished NCT00915031 record still lists
NCT00915031 is an interventional study that assigns participants to a tested intervention. The registered 738 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which UroCool is the first listed.
NCT00915031 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00915031 about?
NCT00915031 is a clinical study titled "Use of Hypothermia During Robotic Prostatectomy". Robotic assisted laparoscopic radical prostatectomy (RLP) has gained widespread acceptance as a standard treatment for clinically localized prostate cancer. Despite the enhanced visualization and precise dissection afforded by the robotic platform, two major comorbidities affect a significant number...
What is the current status of trial NCT00915031?
This trial is currently completed. It is a NA study. The enrollment target is 738 participants. The study started on 2009-08. Estimated completion is 2015-06.
What interventions are being tested in trial NCT00915031?
The interventions under investigation include: UroCool (DEVICE).
Who is sponsoring clinical trial NCT00915031?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00915031's enrollment target sits among peer trials
738 145th of 2000 higher than 1,856 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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