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NCT02035475 · ClinicalTrials.gov registry record · NA
Prevention of Lymphoceles After Robotic PLND
A NA study, sponsored by OhioHealth.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT02035475 is a NA study that has completed, run by OhioHealth. The registered enrollment target is 120 participants.
The verdict
NCT02035475, a NA study, has completed, sponsored by OhioHealth.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE Intuitive Vessel Sealer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2014-08 |
| Est. Completion | 2014-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02035475
The ClinicalTrials.gov registry entry for NCT02035475 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OhioHealth, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Intuitive Vessel Sealer is the first listed.
NCT02035475 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02035475 about?
NCT02035475 is a clinical study titled "Prevention of Lymphoceles After Robotic PLND". 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 i...
What is the current status of trial NCT02035475?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2014-08. Estimated completion is 2014-12.
What interventions are being tested in trial NCT02035475?
The interventions under investigation include: Intuitive Vessel Sealer (DEVICE).
Who is sponsoring clinical trial NCT02035475?
This trial is sponsored by OhioHealth, which has 20 total clinical trials registered on ClinicalTrials.gov.
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