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Completed

NCT Number: NCT04298268

The CUSA Clarity Soft Tissue Removal Study

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Dortmund, Dortmund, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CUSA Clarity Ultrasonic Surgical Aspirator System use

Device

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

Primary outcomes

  1. Effectiveness of soft tissue removal per surgeon assessment.

    Time frame: During the surgery

    Multifactorial 5-point Likert scale (1 (worst) to 5 (best))

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 6, 2020
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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