Benign, Malignant Tumors or Other Soft Tissue RemovalNCT04298268

The CUSA Clarity Soft Tissue Removal Study

An observational study of Benign, Malignant Tumors or Other Soft Tissue Removal and Nephrectomy or Partial Nephrectomy With Parenchyma Removal, run by Integra LifeSciences Corporation at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Benign, Malignant Tumors or Other Soft Tissue Removal, Nephrectomy or Partial Nephrectomy With Parenchyma Removal
What is being tested?: CUSA Clarity Ultrasonic Surgical Aspirator System use
Type of treatment: Medical device
How many people: 100 participants
Where: 5 sitesin 2 countries
Study dates: 30 Mar 2020to 24 Nov 2021
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

Italy4 sites

Niguarda Hospital
Milan
ISMETT
Palermo
Hopital Gemelli U.O.C. Chirurgia Generale ed Epatobiliare
Roma
Policlinico Universitario Agostino Gemelli
Roma

Other trials in Italy

Germany1 site

Klinikum Dortmund
Dortmund, 44137

Other trials in Germany

About this study

Official title: Clinical Performance Investigation of the CUSA® Clarity Ultrasonic Surgical Aspirator System for Soft Tissue Removal During Urological and General Surgery

Conditions: Benign, Malignant Tumors or Other Soft Tissue Removal, Nephrectomy or Partial Nephrectomy With Parenchyma Removal
Being tested: CUSA Clarity Ultrasonic Surgical Aspirator System use
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CUSA Clarity Ultrasonic Surgical Aspirator System useDevice
Assessment of the CUSA® Clarity Ultrasonic Surgical Aspirator System use during urological or general surgery for soft tissue removal

What is being measured

The primary outcome is the main question the study is designed to answer.

Effectiveness of soft tissue removal per surgeon assessment.
Multifactorial 5-point Likert scale (1 (worst) to 5 (best))
Measured: During the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Mar 202024 Nov 2021

First posted6 Mar 2020
Study start30 Mar 2020
Primary completion24 Nov 2021
Study completion24 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Benign, Malignant Tumors or Other Soft Tissue RemovalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04298268
Sponsor's protocol ID: C-CUSATR-001
Status last verified: Feb 2022
First submitted: 18 Feb 2020
Last updated: 8 Feb 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Publications

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.
PubMed 38294895

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Performance Investigation of the CUSA® Clarity Ultrasonic Surgical Aspirator System for Soft Tissue Removal During Urological and General Surgery
ClinicalTrials.gov ID: NCT04298268
Acronym / sponsor ID: C-CUSATR-001
Conditions: Benign, Malignant Tumors or Other Soft Tissue Removal, Nephrectomy or Partial Nephrectomy With Parenchyma Removal
Study type: Observational
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
Study start: 30 Mar 2020 (actual)
Primary completion: 24 Nov 2021 (actual)
Study completion: 24 Nov 2021 (actual)
First posted: 6 Mar 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patient requiring removal of soft tissue with an ultrasonic aspirator during urological or general surgery

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CUSA Clarity Ultrasonic Surgical Aspirator System useAssessment of the CUSA® Clarity Ultrasonic Surgical Aspirator System use during urological or general surgery for soft tissue removal	Device	–

Primary outcome

Effectiveness of soft tissue removal per surgeon assessment.
Time frame: During the surgery
Multifactorial 5-point Likert scale (1 (worst) to 5 (best))

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
Derived from this study: PubMed 38294895Accardo 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.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jason Marzuola study director

Integra LifeSciences

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Italy, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of soft tissue removal per surgeon assessment. (time frame: During the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04298268, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.