Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000815561
Ethics application status
Approved
Date submitted
3/05/2024
Date registered
2/07/2024
Date last updated
13/10/2024
Date data sharing statement initially provided
2/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
SAFETY AND TECHNICAL EVALUATION OF THE CLARIA SYSTEM FOR TISSUE EXTRACTION DURING HYSTERECTOMY
Scientific title
SAFETY AND TECHNICAL EVALUATION OF THE CLARIA SYSTEM FOR TISSUE EXTRACTION DURING HYSTERECTOMY
Secondary ID [1] 312259 0
Nil
Universal Trial Number (UTN)
U1111-1306-3537
Trial acronym
CLARIA-CVP-AUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hysterectomy 333285 0
Condition category
Condition code
Reproductive Health and Childbirth 329976 329976 0 0
Menstruation and menopause
Surgery 330461 330461 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There have been numerous devices that have enabled contained morcellation during hysterectomy. This is the act of capturing the specimen or uterus in a bag or other container and then performing the tissue reduction (or morcellation). If any malignant tissue is present, the expectation is that the container prevents the spread of any malignancies.

The Claria System is a bulk tissue reducer with tissue container for use during hysterectomy (for tissue reduction of the uterus for removal).

The Claria System will be introduced during the planned hysterectomy procedure. The operating surgeon and operating room staff will support the use of the system with the surgeon administering the use of the device. It is expected that the surgery time will be as planned for hysterectomy (1-3 hours).

Claria personnel will be present to ensure that all tasks (steps) are appropriately administered. In addition, the post procedure survey will also capture this information per the surgeon and the OR nurse.

Personnel will undergo consistent training in support of use of the system. All surgeon operators will be provided the same training materials to ensure consistency across all who use the device. OR staff will be provided in-service level training to ensure awareness to the use of the system.
Intervention code [1] 328230 0
Treatment: Devices
Comparator / control treatment
There is no control or comparator group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337739 0
Maintenance of Container integrity will be demonstrated by a validated Claria test method.
Timepoint [1] 337739 0
Immediately post procedure.
Primary outcome [2] 337740 0
Safety will be evaluated as freedom from serious adverse events (SAEs) directly attributable to the Claria System. Adverse events will be identified through active patient monitoring post procedure as well as follow up evaluations post discharge. Medical charts and medications taken/administered will be reviewed to identify any potential AEs.
Timepoint [2] 337740 0
Day 1 through 30-45 days post procedure. The final study visit (day 30-45) will be considered end of study or study exit. The participants will be exited from the study at the time of this contact provided there are no ongoing AEs that are not resolved, stabilized or explained.
Secondary outcome [1] 433075 0
Procedure Success will be defined as completion of critical tasks without task failure or omission.
Timepoint [1] 433075 0
Immediately post procedure.

Eligibility
Key inclusion criteria
Participant will require tissue reduction for the purpose of laparoscopic hysterectomy and tissue cannot be removed (en bloc) through the vagina and subject is a candidate for transvaginal tissue reduction.

Participant is not considered post-menopausal

Participant's vaginal length is equal to or less than 20cm to accommodate the Claria System

Participant has an ultrasound measurement of the uterus showing appropriate size/ dimension for use of the Claria System

Participant's screening is not suggestive of the presence of a malignancy

21Years 50 Years, Females
Minimum age
21 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participant is pregnant or lactating

Participant has evidence of known or suspected malignancy in the abdomen and/or pelvis (the operative space)

Participant presents with adhesions that preclude the performance of the planned procedure

Participant has an implant (e.g., medical device) that may interfere with the use of the Claria system Participant has undiagnosed vaginal bleeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
17/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 316112 0
Commercial sector/Industry
Name [1] 316112 0
Claria Medical, Inc.
Country [1] 316112 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Claria Medical, Inc.
Address
Country
United States of America
Secondary sponsor category [1] 318605 0
None
Name [1] 318605 0
Address [1] 318605 0
Country [1] 318605 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314944 0
Bellberry Human Research Ethics Committee E
Ethics committee address [1] 314944 0
https://bellberry.com.au/
Ethics committee country [1] 314944 0
Australia
Date submitted for ethics approval [1] 314944 0
08/04/2024
Approval date [1] 314944 0
04/06/2024
Ethics approval number [1] 314944 0

Summary
Brief summary
We are doing this research to evaluate a new device intended to improve outcomes in patients undergoing laparoscopic hysterectomy and overall patient care. Historically, without contained tissue reduction, malignancy (cancer) can spread within the pelvic space. The Claria System is designed to capture, reduce, and remove uterine tissue without the spreading of potentially malignant (cancer) cells.

This research study is intended to demonstrate the function of the new Claria System and its ability to successfully contain, morcellate, and remove uterine tissue during hysterectomy. Safety of the system will also be evaluated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133198 0
A/Prof Alan Lam, MD
Address 133198 0
Alan Lam, MD, Centre for Advanced Reproductive Endosurgery (CARE), Level 4, Suite 407-408, AMA House, 69 Christie St., St. Leonards, NSW 2065
Country 133198 0
Australia
Phone 133198 0
+61 2 9966 9121
Fax 133198 0
Email 133198 0
[email protected]
Contact person for public queries
Name 133199 0
Jennifer Murray
Address 133199 0
Jennifer Murray, Consultant, 8950 Ross Station Road, Sebastopol, CA 95472
Country 133199 0
United States of America
Phone 133199 0
+1 650 4001837
Fax 133199 0
Email 133199 0
[email protected]
Contact person for scientific queries
Name 133200 0
Jennifer Murray
Address 133200 0
Jennifer Hebert, Consultant, 8950 Ross Station Road, Sebastopol, CA 95472
Country 133200 0
United States of America
Phone 133200 0
+1 650 4001837
Fax 133200 0
Email 133200 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be shared in aggregate and no single patient will be personally identified.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.