NCT04799210

Human Factors Actual-Use Clinical Protocol

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Eximis Surgical · Industry
• Sex: Female
• Age: 21 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laparoscopic Gynecological Surgery

Interventions

Type	Name	Description
DEVICE	Eximis CS (Contained Segmentation) System	Containment, segmentation and extraction of uterine tissue in pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications.

Timeline

• Start date: 2021-09-16
• Primary completion: 2021-12-13
• Completion: 2021-12-13
• First posted: 2021-03-16
• Last updated: 2022-02-14

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study