The CUSA Clarity Soft Tissue Removal Study

• Sponsor: Integra LifeSciences Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04298268
• Collaborator: (none)
• Enrollment: 100
• Locations: 5
• Actual Duration (Months): 19.8
• Patients Per Site: 20
• Patients Per Site Per Month: 1

Study Details

Study Description

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 through the effectiveness of soft tissue removal per surgeon assessment and Incidence of Adverse Device Effects.

Condition or Disease	Intervention/Treatment	Phase
Benign, Malignant Tumors or Other Soft Tissue Removal; Nephrectomy or Partial Nephrectomy With Parenchyma Removal	Device: CUSA Clarity Ultrasonic Surgical Aspirator System use

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical Performance Investigation of the CUSA® Clarity Ultrasonic Surgical Aspirator System for Soft Tissue Removal During Urological and General Surgery
• Actual Study Start Date: Mar 30, 2020
• Actual Primary Completion Date: Nov 24, 2021
• Actual Study Completion Date: Nov 24, 2021

Outcome Measures

Primary Outcome Measures

1. Effectiveness of soft tissue removal per surgeon assessment. [During the surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinikum Dortmund	Dortmund		Germany	44137
2	Niguarda Hospital	Milano		Italy
3	ISMETT	Palermo		Italy
4	Hopital Gemelli U.O.C. Chirurgia Generale ed Epatobiliare	Roma		Italy
5	Policlinico Universitario Agostino Gemelli	Roma		Italy

Sponsors and Collaborators

• Integra LifeSciences Corporation

Investigators

• Study Director: Jason Marzuola, Integra LifeSciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Integra LifeSciences Corporation
• ClinicalTrials.gov Identifier: NCT04298268
• Other Study ID Numbers: C-CUSATR-001
• First Posted: Mar 6, 2020
• Last Update Posted: Feb 8, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Feb 8, 2022