The CUSA Clarity Soft Tissue Removal Study
February 7, 2022 updated by: Integra LifeSciences Corporation
Clinical Performance Investigation of the CUSA® Clarity Ultrasonic Surgical Aspirator System for Soft Tissue Removal During Urological and General Surgery
To investigate the clinical performance and surgeon preferences of the CUSA® Clarity Ultrasonic Surgical Aspirator System for soft tissue removal during surgical procedures.
This will be evaluated through the effectiveness of soft tissue removal per surgeon assessment and Incidence of Adverse Device Effects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient requiring removal of soft tissue with an ultrasonic aspirator during urological or general surgery
Description
Inclusion Criteria:
- Subject is at least 18 years of age
- Subject requires removal of soft tissue with an ultrasonic aspirator during urological or general surgery
- Subject is an appropriate candidate to receive use of the CUSA® Clarity Ultrasonic Surgical Aspirator System product for soft tissue removal during surgery, per the study surgeon
- Subject signed the IRB/EC-approved informed consent form demonstrating that the subject is willing and able to participate in this clinical study and to comply with all study procedures, if applicable.
Exclusion Criteria:
- Subject is currently pregnant or plans to become pregnant prior to the study index surgery
- Subject has any significant medical condition that in the opinion of the investigator will interfere with protocol evaluation and participation
- Subject's surgical plan includes utilizing CUSA® Clarity Ultrasonic Surgical Aspirator System for the removal of uterine fibroids
- Subject is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator or ethics committee.
- Intra-operative exclusion criteria : Surgeon does not utilize the CUSA® Clarity Ultrasonic Surgical Aspirator System for soft tissue removal during surgery.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness of soft tissue removal per surgeon assessment.
Time Frame: During the surgery
|
Multifactorial 5-point Likert scale (1 (worst) to 5 (best))
|
During the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jason Marzuola, Integra LifeSciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 30, 2020
Primary Completion (Actual)
November 24, 2021
Study Completion (Actual)
November 24, 2021
Study Registration Dates
First Submitted
February 18, 2020
First Submitted That Met QC Criteria
March 5, 2020
First Posted (Actual)
March 6, 2020
Study Record Updates
Last Update Posted (Actual)
February 8, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-CUSATR-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.