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

Eximis Surgical7 sites in 1 country3 target enrollmentSeptember 16, 2021

ConditionsLaparoscopic Gynecological Surgery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Laparoscopic Gynecological Surgery
Sponsor: Eximis Surgical
Enrollment: 3
Locations: 7
Primary Endpoint: The number of procedures where all critical tasks related to the Eximis CS are performed without serious use error.
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

September 16, 2021

End Date

December 13, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Eximis Surgical

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The number of procedures where all critical tasks related to the Eximis CS are performed without serious use error.

Time Frame: Through study completion, anticipated to be 4-6 months

Primary Endpoint

Secondary Outcomes

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