Human Factors Actual-Use Clinical Protocol

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Human Factors Actual-Use Confirmatory Validation Study of the Eximis CS (Contained Segmentation) System (Contain Study)

Conditions
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Laparoscopic Gynecological Surgery

Intervention / Treatment
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* Device: Eximis CS (Contained Segmentation) System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >/= 21 and < 50 years. Planned laparoscopic hysterectomy or myomectomy. Tissue specimen is <11 cm in maximum diameter based on standard preoperative assessment. Pre-operative evaluation which may include imaging, cervical cancer screening, and endometrial biopsy has been completed. Signed informed consent. Willing to adhere to protocol requirements and complete follow-up. Exclusion Criteria: Subject is post-menopausal, defined as amenorrhea >12 months in the absence of ovulation suppression. Known or suspected malignancy of gynecological origin as determined by standard clinical practice. Candidate for en bloc tissue removal, for example through the vagina or via a mini-laparotomy incision. Hemoglobin < 8 g/dl within 30 days prior to surgery. Subject has a current history of undiagnosed genital bleeding. Subject has an implanted electronic device where use of radiofrequency (RF) energy would be contraindicated (e.g., pacemaker, internal defibrillator). Medical condition, surgical history, or intra-operative findings, which in the option of the investigator, precludes utilization of the Eximis CS System. Known allergy to polyurethane, polyethylene, thermoplastic fluoropolymer and/or chlorinated polyvinyl chloride. Concurrent participation in another therapeutic or interventional clinical trial with investigational pharmaceutical agent(s) or medical device(s) that could impact evaluation of this study as determined by the Investigator. Inability to comply with the study procedures or follow-up in the opinion of the investigator. Subject is pregnant. Intraoperative Exclusion: Abdominal wall thickness at the umbilicus incision site is > 8 cm.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human Factors Actual Use<br>Confirm device use safety and effectiveness of the Eximis CS (Contained Segmentation) System in actual use | Device: Eximis CS (Contained Segmentation) System<br>* Containment, segmentation and extraction of uterine tissue in pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications.<br>* Other names: EX-900K-CLIN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of procedures where all critical tasks related to the Eximis CS are performed without serious use error. | Primary Endpoint | Through study completion, anticipated to be 4-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of procedures successfully completed with use of the Eximis CS device. | Secondary Endpoint | Through study completion, anticipated to be 4-6 months | 
| Number of Capture Bags with breach of containment. | Secondary Endpoint | Through study completion, anticipated to be 4-6 months | 
| The number and severity of user adverse events caused by use error. | Secondary Endpoint | Day of surgery | 
| The number and severity of subject adverse events caused by use error. | Secondary Endpoint | Minimum 30 days (Standard of care follow-up 4-6 weeks) | 
| All other adverse events. | Secondary Endpoint | Minimum 30 days (Standard of care follow-up 4-6 weeks) |