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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the decrease of post-operative morbidity in inguinal lymphadenectomies realised for vulvar tumors and inferior limb skin tumors by use of Ultracision with regard to classical operative techniques.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vulvar Neoplasms Skin Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Classical surgical Inguinal curage

Classical Inguinal curage

Group Type ACTIVE_COMPARATOR

classical lymphadenectomy

Intervention Type DEVICE

classical lymphadenectomy

Ultracision surgical Inguinal curage

Group Type EXPERIMENTAL

ultracision

Intervention Type DEVICE

Surgery by Ultracision

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ultracision

Surgery by Ultracision

Intervention Type DEVICE

classical lymphadenectomy

classical lymphadenectomy

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Vulvar neoplasm, inferior limb's skin malignant tumours, with an inguinal curage indication.
* 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

* Preliminary surgery of inguinal cavity (sentinel lymph node removal accepted)
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut Claudius Regaud

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Denis Querleu, Pr

Role: PRINCIPAL_INVESTIGATOR

Institut Claudius Regaud

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut Paoli-Calmettes

Marseille, , France

Site Status

Institut Claudius Regaud

Toulouse, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

05 DIVE 03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.