The purpose of this study is to confirm device use safety and effectiveness of the Eximis CS (Contained Segmentation) System in actual use by representative users, use, and use environments as required for regulatory agency clearance for commercial use.
This is a prospective, multi-center, single-arm study to confirm device use safety and effectiveness in an actual use setting when utilized by gynecological surgeons during surgery for containment, segmentation and extraction of uterine tissue in pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Containment, segmentation and extraction of uterine tissue in pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications.
Advanced Women's Health Institute
Greenwood Village, Colorado, United States
AdventHealth Medical Group Gynecologic Surgery at Celebration
Celebration, Florida, United States
Swor Women's Care
Sarasota, Florida, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
The number of procedures where all critical tasks related to the Eximis CS are performed without serious use error.
Primary Endpoint
Time frame: Through study completion, anticipated to be 4-6 months
Number of procedures successfully completed with use of the Eximis CS device.
Secondary Endpoint
Time frame: Through study completion, anticipated to be 4-6 months
Number of Capture Bags with breach of containment.
Secondary Endpoint
Time frame: Through study completion, anticipated to be 4-6 months
The number and severity of user adverse events caused by use error.
Secondary Endpoint
Time frame: Day of surgery
The number and severity of subject adverse events caused by use error.
Secondary Endpoint
Time frame: Minimum 30 days (Standard of care follow-up 4-6 weeks)
All other adverse events.
Secondary Endpoint
Time frame: Minimum 30 days (Standard of care follow-up 4-6 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Advanced Gynecologic Surgery Institute
Park Ridge, Illinois, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
ProMedica Health System
Sylvania, Ohio, United States