Human Factors Actual-Use Clinical Protocol

Stopped early · Not applicable

Conditions studied: Laparoscopic Gynecological Surgery

In brief

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.

Key facts

Study ID

NCT04799210

Run by

Eximis Surgical

People needed

3

Starts

2021-09-16

Expected to finish

2021-12-13

Last updated by the study team

2022-02-14

Who can join

Age: 21 and older, up to 49. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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