None listed
Conditions
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.
Interventions
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
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.
Sponsors
Claria Medical, Inc.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 50 Years
Healthy volunteers
No
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
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
Outcome results
None listed