The CUSA Clarity Soft Tissue Removal Study

Completed

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

• Registration Number: NCT04298268
• Lead Sponsor: Integra LifeSciences Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-06
• Study Start: 2020-03-30
• Primary Completion: 2021-11-24
• Study Completion: 2021-11-24
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (5)

Niguarda Hospital; 🇮🇹 Milano, Italy

Policlinico Universitario Agostino Gemelli; 🇮🇹 Roma, Italy

ISMETT; 🇮🇹 Palermo, Italy

Klinikum Dortmund; 🇩🇪 Dortmund, Germany

Hopital Gemelli U.O.C. Chirurgia Generale ed Epatobiliare; 🇮🇹 Roma, Italy