Vulvar NeoplasmsPhase 3NCT00224744
Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage
A Phase 3 study testing ultracision and classical lymphadenectomy in people with Vulvar Neoplasms and Skin Neoplasms, run by Institut Claudius Regaud at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vulvar Neoplasms, Skin Neoplasms
- What is being tested?
- ultracision and classical lymphadenectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2005to Jan 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut Paoli-Calmettes
Marseille
Institut Claudius Regaud
Toulouse
About this study
Official title: Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage.
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.
- Conditions
- Vulvar Neoplasms, Skin Neoplasms
- Being tested
- ultracision, classical lymphadenectomy
- Keywords
- Vulvar Neoplasms, Skin Neoplasms, Ultracision, Lymphadenectomy
- Medical subject headings
- Vulvar Neoplasms, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultracisionDevice
Surgery by Ultracision
classical lymphadenectomyDevice
classical lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| Classical surgical Inguinal curage | Active comparator | Classical Inguinal curage Receives: Device: classical lymphadenectomy |
| Ultracision surgical Inguinal curage | Experimental | Not described Receives: Device: ultracision |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the decrease of post-operative morbidity.
Measured: 2012
Secondary outcomes (1)
To study differences between the two techniques according to : operative duration ; operative difficulties ; quantity of drainage ; hospitalization's duration ; necessity of local care ; number of consultations ; medical and economical assessment.
Measured: 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startNov 2005
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Querleu, Pr, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224744
- Sponsor's protocol ID
- 05 DIVE 03
- Status last verified
- Jun 2013
- First submitted
- 22 Sep 2005
- Last updated
- 12 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage.
- ClinicalTrials.gov ID
- NCT00224744
- Acronym / sponsor ID
- 05 DIVE 03
- Conditions
- Vulvar Neoplasms, Skin Neoplasms
- Keywords
- Vulvar Neoplasms, Skin Neoplasms, Ultracision, Lymphadenectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 23 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classical surgical Inguinal curage | Active comparator | Device: classical lymphadenectomyClassical Inguinal curage |
| Ultracision surgical Inguinal curage | Experimental | Device: ultracision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultracisionSurgery by Ultracision | Device | Ultracision surgical Inguinal curage |
| classical lymphadenectomyclassical lymphadenectomy | Device | Classical surgical Inguinal curage |
Primary outcome
To evaluate the decrease of post-operative morbidity.
Time frame: 2012
1 secondary outcome
To study differences between the two techniques according to : operative duration ; operative difficulties ; quantity of drainage ; hospitalization's duration ; necessity of local care ; number of consultations ; medical and economical assessment.
Time frame: 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Querleu, Pr principal investigator
Institut Claudius Regaud
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ultracision and classical lymphadenectomy in people with Vulvar Neoplasms and Skin Neoplasms, run by Institut Claudius Regaud at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the decrease of post-operative morbidity. (time frame: 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2014.