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Study to Evaluate the Role of PlasmaJet in Patients Undergoing Groin Node Dissection for Vulval Cancer

NCT04105465 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-09-27

No results posted yet for this study

Summary

Surgery for vulvar cancer involves removal of the central tumour as well as groin node dissection as indicated depending on the stage of tumour. Groin node dissection is associated with significant complications including lymphorrea, lymphocyst formation, wound breakdown as well as long term complications including lymphedema.

This study has been designed with each patient acting as their own control to investigate if using the PlasmaJet during surgery is associated with a reduction in the above mentioned complications.

Conditions

  • Vulvar Cancer
  • Groin Node

Interventions

DEVICE

PlasmaJet

The PlasmaJet device is used following groin node dissection on the side randomised to receive it as per protocol specifications

Sponsors & Collaborators

  • Royal Surrey County Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Thumuluru K Madhuri, MD · Royal Surrey County Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-07-31
Completion
2016-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04105465 on ClinicalTrials.gov