The CUSA Clarity Soft Tissue Removal Study

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

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-30

Study Completion Date

2021-11-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Benign, Malignant Tumors or Other Soft Tissue Removal Nephrectomy or Partial Nephrectomy With Parenchyma Removal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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CUSA Clarity Ultrasonic Surgical Aspirator System use

Assessment of the CUSA® Clarity Ultrasonic Surgical Aspirator System use during urological or general surgery for soft tissue removal

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No