Clinical trial · Observational
The CUSA Clarity Soft Tissue Removal Study
Clinical Performance Investigation of the CUSA® Clarity Ultrasonic Surgical Aspirator System for Soft Tissue Removal During Urological and General Surgery
NCT04298268CI-TRIAL-00056386completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign, Malignant Tumors or Other Soft Tissue Removal | — | UNRESOLVED | — |
| Nephrectomy or Partial Nephrectomy With Parenchyma Removal | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CUSA Clarity Ultrasonic Surgical Aspirator System use | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Effectiveness of soft tissue removal per surgeon assessment.
- timeFrame
- During the surgery
- description
- Multifactorial 5-point Likert scale (1 (worst) to 5 (best))
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDAccardo 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. PMID 38294895