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JOURNAL ONKOLOGIE – STUDIE

The CUSA Clarity Soft Tissue Removal Study

Rekrutierend

NCT-Nummer:
NCT04298268

Studienbeginn:
März 2020

Letztes Update:
26.03.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Integra LifeSciences Corporation

Collaborator:
-

Studienleiter

Jason Marzuola
Study Director
Integra LifeSciences

Kontakt

Studienlocations
(3 von 5)

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

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

Geprüfte Regime

  • 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

Quelle: ClinicalTrials.gov


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