Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage
NCT ID: NCT00224744
Last Updated: 2014-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
73 participants
INTERVENTIONAL
2005-11-30
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Classical surgical Inguinal curage
Classical Inguinal curage
classical lymphadenectomy
classical lymphadenectomy
Ultracision surgical Inguinal curage
ultracision
Surgery by Ultracision
Interventions
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ultracision
Surgery by Ultracision
classical lymphadenectomy
classical lymphadenectomy
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Hematological functions : leucocytes \> 1500/mm3, hemoglobin \> 8 g/dl, blood platelets \> 150000/mm3.
* Well informed written consent signed by the patient
* Negative pregnancy test for female patient of child-bearing potential.
Exclusion Criteria
* Massive lymph node invasion with femoro-vessels attack
* Inclusion in another study (excepted study turned to inguinal lymph node)
* Pregnant or nursing women
* Patient under guardianship or trusteeship
18 Years
ALL
No
Sponsors
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Institut Claudius Regaud
OTHER
Responsible Party
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Principal Investigators
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Denis Querleu, Pr
Role: PRINCIPAL_INVESTIGATOR
Institut Claudius Regaud
Locations
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Institut Paoli-Calmettes
Marseille, , France
Institut Claudius Regaud
Toulouse, , France
Countries
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Other Identifiers
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05 DIVE 03
Identifier Type: -
Identifier Source: org_study_id
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