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CompletedNCT04298268Updated Feb 8, 2022

The CUSA Clarity Soft Tissue Removal Study

An observational study in Benign, Malignant Tumors or Other Soft Tissue Removal and Nephrectomy or Partial Nephrectomy With Parenchyma Removal, sponsored by Integra LifeSciences Corporation. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-08.

Sponsored by Integra LifeSciences Corporation · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Benign, Malignant Tumors or Other Soft Tissue Removal
  • Nephrectomy or Partial Nephrectomy With Parenchyma Removal

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 100 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

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Lead sponsor

Integra LifeSciences Corporation is the lead sponsor of 81 studies on the registry; 5 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient requiring removal of soft tissue with an ultrasonic aspirator during urological or general surgery

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • DeviceCUSA 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

06

What researchers measure

Primary outcomes

  1. Effectiveness of soft tissue removal per surgeon assessment.

    Multifactorial 5-point Likert scale (1 (worst) to 5 (best))

    Time frame: During the surgery

07

Study locations

5 sites
  • Klinikum Dortmund
    Dortmund, 44137, Germany
  • Niguarda Hospital
    Milano, Italy
  • ISMETT
    Palermo, Italy
  • Hopital Gemelli U.O.C. Chirurgia Generale ed Epatobiliare
    Roma, Italy
  • Policlinico Universitario Agostino Gemelli
    Roma, Italy
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04298268
Lead sponsor
Integra LifeSciences Corporation
Responsible party
Sponsor
First posted
Mar 6, 2020
Start date
Mar 30, 2020
Primary completion
Nov 24, 2021
Completion
Nov 24, 2021
Last update
Feb 8, 2022

Study contacts

Jason Marzuola
study director · Integra LifeSciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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