Human Factors Actual-Use Clinical Protocol

Not Applicable

Terminated

• Conditions: Laparoscopic Gynecological Surgery
• Interventions: Device: Eximis CS (Contained Segmentation) System

• Registration Number: NCT04799210
• Lead Sponsor: Eximis Surgical

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.

Study Timeline

• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-16
• Study Start: 2021-09-16
• Primary Completion: 2021-12-13
• Study Completion: 2021-12-13
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-03
• Last Update Posted: 2022-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

Inclusion Criteria

1. Age >/= 21 and < 50 years.
2. Planned laparoscopic hysterectomy or myomectomy.
3. Tissue specimen is <11 cm in maximum diameter based on standard preoperative assessment.
4. Pre-operative evaluation which may include imaging, cervical cancer screening, and endometrial biopsy has been completed.
5. Signed informed consent.
6. Willing to adhere to protocol requirements and complete follow-up.

Exclusion Criteria

1. Subject is post-menopausal, defined as amenorrhea >12 months in the absence of ovulation suppression.
2. Known or suspected malignancy of gynecological origin as determined by standard clinical practice.
3. Candidate for en bloc tissue removal, for example through the vagina or via a mini-laparotomy incision.
4. Hemoglobin < 8 g/dl within 30 days prior to surgery.
5. Subject has a current history of undiagnosed genital bleeding.
6. Subject has an implanted electronic device where use of radiofrequency (RF) energy would be contraindicated (e.g., pacemaker, internal defibrillator).
7. Medical condition, surgical history, or intra-operative findings, which in the option of the investigator, precludes utilization of the Eximis CS System.
8. Known allergy to polyurethane, polyethylene, thermoplastic fluoropolymer and/or chlorinated polyvinyl chloride.
9. 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.
10. Inability to comply with the study procedures or follow-up in the opinion of the investigator.
11. Subject is pregnant.
12. Intraoperative Exclusion: Abdominal wall thickness at the umbilicus incision site is > 8 cm.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Human Factors Actual Use	Eximis CS (Contained Segmentation) System	Confirm device use safety and effectiveness of the Eximis CS (Contained Segmentation) System in actual use

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Advanced Gynecologic Surgery Institute; 🇺🇸 Park Ridge, Illinois, United States

Advanced Women's Health Institute; 🇺🇸 Greenwood Village, Colorado, United States

AdventHealth Medical Group Gynecologic Surgery at Celebration; 🇺🇸 Celebration, Florida, United States

ProMedica Health System; 🇺🇸 Sylvania, Ohio, United States

Swor Women's Care; 🇺🇸 Sarasota, Florida, United States

NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States