The CUSA Clarity Soft Tissue Removal Study

Clinical Performance Investigation of the CUSA® Clarity Ultrasonic Surgical Aspirator System for Soft Tissue Removal During Urological and General Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04298268

Enrollment

100

Registered

2020-03-06

Start date

2020-03-30

Completion date

2021-11-24

Last updated

2022-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

DEVICECUSA 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Effectiveness of soft tissue removal per surgeon assessment.	During the surgery	Multifactorial 5-point Likert scale (1 (worst) to 5 (best))

Countries

Germany, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026