Status:
COMPLETED
The CUSA Clarity Soft Tissue Removal Study
Lead Sponsor:
Integra LifeSciences Corporation
Conditions:
Benign, Malignant Tumors or Other Soft Tissue Removal
Nephrectomy or Partial Nephrectomy With Parenchyma Removal
Eligibility:
All Genders
18+ years
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 thr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 24 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04298268
Start Date
March 30 2020
End Date
November 24 2021
Last Update
February 8 2022
Active Locations (5)
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1
Klinikum Dortmund
Dortmund, Germany, 44137
2
Niguarda Hospital
Milan, Italy
3
ISMETT
Palermo, Italy
4
Hopital Gemelli U.O.C. Chirurgia Generale ed Epatobiliare
Roma, Italy