The purpose of this study is to evaluate device safety and effectiveness of the Eximis CS System.
This is a prospective, multi-center, single-arm study to confirm device safety and effectiveness when utilized for containment, segmentation, and extraction of uterine tissue in pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications. Eligible subjects who have signed an informed consent form (ICF) will be enrolled. Subjects will be sequentially enrolled and assigned a study identification number. Surgeons will also be assigned a unique number. Subjects will undergo the standard of care regarding all aspects of the pre-operative, surgical, and follow-up procedures. The aspect unique to this study is the capture, segmentation, and extraction of the target tissue will utilize one integrated device, the Eximis CS System, which segments tissue via segmenting wires using RF energy. The device is not intended to provide any therapeutic effect. All subjects will be followed for safety through two post-procedure follow-up visits. One will be scheduled at a minimum of 14 days and a maximum of 21 days post-operatively. The second will be a follow-up phone call scheduled at a minimum of 30 days and a maximum of 45 days post-operatively.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
23
The Eximis CS System is an integrated system consisting of a 900 mL Capture Bag, Inflation Mechanism, two Eximis Segmenters, and the Eximis RF Generator.
Advent Health, 410 Celebration Place
Celebration, Florida, United States
Rosemark Womens Care Specialists
Idaho Falls, Idaho, United States
Maimonides Medical Center
Brooklyn, New York, United States
Oregon Health and Science University School of Medicine
Portland, Oregon, United States
Performance
Percentage of procedures successfully completed with use of the Eximis CS device per the Instructions for Use and without breach of the containment bag.
Time frame: 2 months
Usability
Percentage of procedures where all critical tasks related to the Eximis CS are performed without observed failure or omission. Percentage of procedures requiring critical troubleshooting steps (i.e., extending an incision, employing alternate tissue removal techniques) per the Instructions for Use Percentage of procedures requiring other troubleshooting steps (i.e., replacing the RF Generator, Segmenter, or Capture Bag; cutting Segmenter wires; responding to an alarm or information signal) per the Instructions for Use
Time frame: 2 months
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