Vulvar Intraepithelial NeoplasiaNCT06297187
Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study
An observational study of Vulvar Intraepithelial Neoplasia and Condylomata Acuminata, run by Integra LifeSciences Corporation at 1 site in United States.
Trial summary
The study is a single arm, retrospective, single-center, post market registry. The purpose of this Registry is to collect data to demonstrate the safety and performance of CUSA® for the treatment of Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Intraepithelial Neoplasia, Condylomata Acuminata
- What is being tested?
- CUSA (Cavitronic Ultrasonic Surgical Aspirator)
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2024to 31 Aug 2024
- Phase
- Observational
- 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
- Women only
- Adult, Older adult
Study population: Patients identified as genetically female at birth between the ages of 18 and greater (inclusive) at the time they underwent treatment with CUSA for Vulvar Intraepithelial Neoplasia (VIN) or condyloma acuminata between January 2010 and December 2022. Pregnant patients will be included.
Who may be able to join
- Subject had been diagnosed with primary or recurrent Vulvar Intraepithelial Neoplasia (VIN) or condyloma acuminata, treated with CUSA and confirmed by a CUSA pathology report.
- Subject had post-operative visits completed at the gynecologic oncology practice.
- Subject had surgery with CUSA between January 2010 and December 2022.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Cancer and Blood Disorders
Dallas, Texas, 76014
About this study
Official title: A Retrospective Registry on the Use of CUSA® for the Treatment of Vulvar Intraepithelial Neoplasia (VIN) and Condyloma Acuminata
The study is a single arm, retrospective, single-center, post market registry.
The purpose of this Registry is to collect data to demonstrate the safety and performance of CUSA® for the treatment of Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata.
Read the detailed description
CUSA® Excel/Clarity Ultrasonic Surgical Aspirator System is indicated for use in the following surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable:
- Neurosurgery
- Gastrointestinal and affiliated organ surgery
- Urological surgery
- General surgery
- Orthopedic surgery
- Gynecological surgery
- Laparoscopic surgery
This Registry adds data to support the safety and efficacy for a gynecological surgery indication expansion for the use of CUSA in Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata.
Information obtained from this retrospective Registry will help inform a potential future prospective study for this indication in a real-world population.
- Being tested
- CUSA (Cavitronic Ultrasonic Surgical Aspirator)
- Keywords
- Gynecologic Oncology, VIN, Vulvar Intraepithelial Neoplasia, Condylomata Acuminata
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUSA (Cavitronic Ultrasonic Surgical Aspirator)Device
CUSA® Excel and CUSA® Clarity Ultrasonic Surgical Aspirator Systems are indicated for use in the surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable.
| Study group | Role | What they receive |
|---|---|---|
| CUSA Excel® | Subjects having had treatment for Vulvar Intraepithelial Neoplasia (VIN) and/or condyloma acuminata using CUSA® Excel system. Receives: Device: CUSA (Cavitronic Ultrasonic Surgical Aspirator) | |
| CUSA Clarity® | Subject having had treatment for Vulvar Intraepithelial Neoplasia (VIN) and/or condyloma acuminata using CUSA® Clarity system. Receives: Device: CUSA (Cavitronic Ultrasonic Surgical Aspirator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects with Complete Removal of Vulvar Intraepithelial Neoplasia and condyloma acuminata
Ability of CUSA to completely remove Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata.
Measured: During Surgery
Secondary outcomes (1)
Primary Site Recurrence
Incidence of Primary Site Recurrence of Vulvar Intraepithelial Neoplasia or condyloma acuminata.
Measured: Up to 12 months Postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start23 Feb 2024
- Primary completion31 Jul 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar Intraepithelial NeoplasiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- DeEtte Vasques, DO, Principal investigator, Private Practice, Dallas, Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297187
- Sponsor's protocol ID
- C-CUSAWH-001
- Status last verified
- Sep 2024
- First submitted
- 27 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Registry on the Use of CUSA® for the Treatment of Vulvar Intraepithelial Neoplasia (VIN) and Condyloma Acuminata
- ClinicalTrials.gov ID
- NCT06297187
- Acronym / sponsor ID
- C-CUSAWH-001
- Keywords
- Gynecologic Oncology, VIN, Vulvar Intraepithelial Neoplasia, Condylomata Acuminata
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 7 Mar 2024 (actual)
- 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 study is a single arm, retrospective, single-center, post market registry.
The purpose of this Registry is to collect data to demonstrate the safety and performance of CUSA® for the treatment of Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata.
Detailed description
CUSA® Excel/Clarity Ultrasonic Surgical Aspirator System is indicated for use in the following surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable:
- Neurosurgery
- Gastrointestinal and affiliated organ surgery
- Urological surgery
- General surgery
- Orthopedic surgery
- Gynecological surgery
- Laparoscopic surgery
This Registry adds data to support the safety and efficacy for a gynecological surgery indication expansion for the use of CUSA in Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata.
Information obtained from this retrospective Registry will help inform a potential future prospective study for this indication in a real-world population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CUSA Excel® | – | Device: CUSA (Cavitronic Ultrasonic Surgical Aspirator)Subjects having had treatment for Vulvar Intraepithelial Neoplasia (VIN) and/or condyloma acuminata using CUSA® Excel system. |
| CUSA Clarity® | – | Device: CUSA (Cavitronic Ultrasonic Surgical Aspirator)Subject having had treatment for Vulvar Intraepithelial Neoplasia (VIN) and/or condyloma acuminata using CUSA® Clarity system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients identified as genetically female at birth between the ages of 18 and greater (inclusive) at the time they underwent treatment with CUSA for Vulvar Intraepithelial Neoplasia (VIN) or condyloma acuminata between January 2010 and December 2022. Pregnant patients will be included.
Key inclusion criteria (3 listed)
- Subject had been diagnosed with primary or recurrent Vulvar Intraepithelial Neoplasia (VIN) or condyloma acuminata, treated with CUSA and confirmed by a CUSA pathology report.
- Subject had post-operative visits completed at the gynecologic oncology practice.
- Subject had surgery with CUSA between January 2010 and December 2022.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CUSA (Cavitronic Ultrasonic Surgical Aspirator)CUSA® Excel and CUSA® Clarity Ultrasonic Surgical Aspirator Systems are indicated for use in the surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable. | Device | CUSA Clarity®, CUSA Excel® |
Primary outcome
Proportion of Subjects with Complete Removal of Vulvar Intraepithelial Neoplasia and condyloma acuminata
Time frame: During Surgery
Ability of CUSA to completely remove Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata.
1 secondary outcome
Primary Site Recurrence
Time frame: Up to 12 months Postoperatively.
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 19 Sep 2024.
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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.
DeEtte Vasques, DO principal investigator
Private Practice, Dallas, Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulvar Intraepithelial Neoplasia and Condylomata Acuminata, run by Integra LifeSciences Corporation at 1 site in United States.
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 3 inclusion and 0 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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?
Proportion of Subjects with Complete Removal of Vulvar Intraepithelial Neoplasia and condyloma acuminata (time frame: During Surgery). 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 19 Sep 2024.