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Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study

NCT06297187 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 56

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Vulvar Intraepithelial Neoplasia
  • Condylomata Acuminata

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • DeEtte Vasques, DO · Private Practice, Dallas, Texas

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-23
Primary Completion
2024-07-31
Completion
2024-08-31
FDA Device
Yes

Countries

  • United States

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 NCT06297187 on ClinicalTrials.gov