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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of soft tissue removal per surgeon assessment. | Multifactorial 5-point Likert scale (1 (worst) to 5 (best)) | During the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patient requiring removal of soft tissue with an ultrasonic aspirator during urological or general surgery
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| Name | Affiliation | Role |
|---|---|---|
| Jason Marzuola | Integra LifeSciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Dortmund | Dortmund | 44137 | Germany | |||
| Niguarda Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38294895 | Derived | Accardo C, Gruttadauria S, Decarlis L, Agnes S, Schmeding M, Avolio AW, Buscemi V, Ardito F, Kienlein S, Mbuvi PM, Giuliante F. The CUSA Clarity Soft Tissue Removal Study: Clinical Performance Investigation of the CUSA Clarity Ultrasonic Surgical Aspirator System for Soft Tissue Removal During Liver Surgery. J Laparoendosc Adv Surg Tech A. 2024 Feb;34(2):99-105. doi: 10.1089/lap.2023.0467. Epub 2024 Jan 31. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 2, 2023 | |
| Reset | Dec 8, 2023 | |
| Release | Dec 15, 2023 | |
| Reset | May 30, 2024 | |
| Release | Jun 27, 2024 | |
| Reset | Sep 27, 2024 | |
| Release | Jan 6, 2025 | |
| Reset | Feb 3, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 2, 2023 | Dec 8, 2023 | |||
| Dec 15, 2023 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Milan |
| Italy |
| ISMETT | Palermo | Italy |
| Hopital Gemelli U.O.C. Chirurgia Generale ed Epatobiliare | Roma | Italy |
| Policlinico Universitario Agostino Gemelli | Roma | Italy |
| May 30, 2024 |
| Jun 27, 2024 | Sep 27, 2024 |
| Jan 6, 2025 | Feb 3, 2025 |