Prostate Cancer Clinical Trial
— PLNDOfficial title:
A Pilot Clinical Trial for the Prevention of Lymphoceles After Robotic Pelvic Lymph Node Dissections for Prostate Malignancies Using the da Vinci® EndoWrist® One™ Vessel Sealer
Verified date | July 2014 |
Source | OhioHealth |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da
Vinci Si robotic surgical system. It is intended for bipolar coagulation and mechanical
transection of vessels up to 7 mm in diameter and tissue bundles that fit within the jaws of
the instrument. Their use in this study will be to perform tissue transection during PLND
such that the intended use is within the FDA-approved domain for this instrument.
Investigators intend to identify whether its use for PLND reduces lymphoceles given that the
device is known to seal vessels up to 7 mm, which is much larger than lymphatic vessels
encountered during PLND. Because the instrument is new and has been FDA approved for less
than one year, there is no published literature regarding its use to date.
Our hypothesis is that using the Vessel Sealer on a single side of the pelvis will reduce
the incidence of screening detected lymphoceles on that side. Investigators propose a total
sample size of 120 patients.
Status | Completed |
Enrollment | 120 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age 18 or older - Candidate scheduled to undergo robotic prostatectomy surgery with PLND Exclusion Criteria: - Age < 18 - Unable to give informed consent - Non-English speaking - Not a candidate for robotic surgery for any reason |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Dublin Methodist Hospital | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
OhioHealth | Intuitive Surgical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of lymphoceles | Identify whether the use of the Vessel Sealer for PLND reduces the incidence of screening detected lymphoceles via CT scan of the pelvis by comparing the Vessel Sealer side of the pelvis with the control side of the pelvis. | 4 months | No |
Secondary | Surgical complications | Evaluate perioperative and postoperative surgical outcomes at 4 months after surgery. Possible outcomes include "no complications" (0), "minor complications" (1), and "major complications" (2). | 4 months | No |
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