Benign, Malignant Tumors or Other Soft Tissue Removal Clinical Trial
Official title:
Clinical Performance Investigation of the CUSA® Clarity Ultrasonic Surgical Aspirator System for Soft Tissue Removal During Urological and General Surgery
| Verified date | February 2022 |
| Source | Integra LifeSciences Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | November 24, 2021 |
| Est. primary completion date | November 24, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Klinikum Dortmund | Dortmund | |
| Italy | Niguarda Hospital | Milano | |
| Italy | ISMETT | Palermo | |
| Italy | Hopital Gemelli U.O.C. Chirurgia Generale ed Epatobiliare | Roma | |
| Italy | Policlinico Universitario Agostino Gemelli | Roma |
| Lead Sponsor | Collaborator |
|---|---|
| Integra LifeSciences Corporation |
Germany, Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Effectiveness of soft tissue removal per surgeon assessment. | Multifactorial 5-point Likert scale (1 (worst) to 5 (best)) | During the surgery |