The CUSA Clarity Soft Tissue Removal Study

Integra LifeSciences

Status: Completed

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

Treatments: Device: CUSA Clarity Ultrasonic Surgical Aspirator System use

Study type: Observational

Funder types: Industry

Identifiers

NCT04298268

C-CUSATR-001

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 exclusion criteria : Surgeon does not utilize the CUSA® Clarity Ultrasonic Surgical Aspirator System for soft tissue removal during surgery.