NCT06572163

Clinical Validation Study of the Eximis CS (Contained Segmentation) System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Eximis Surgical · Industry
• Sex: Female
• Age: 21 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate device safety and effectiveness of the Eximis CS System.

Detailed description

This is a prospective, multi-center, single-arm study to confirm device safety and effectiveness when utilized for containment, segmentation, and extraction of uterine tissue in pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications. Eligible subjects who have signed an informed consent form (ICF) will be enrolled. Subjects will be sequentially enrolled and assigned a study identification number. Surgeons will also be assigned a unique number. Subjects will undergo the standard of care regarding all aspects of the pre-operative, surgical, and follow-up procedures. The aspect unique to this study is the capture, segmentation, and extraction of the target tissue will utilize one integrated device, the Eximis CS System, which segments tissue via segmenting wires using RF energy. The device is not intended to provide any therapeutic effect. All subjects will be followed for safety through two post-procedure follow-up visits. One will be scheduled at a minimum of 14 days and a maximum of 21 days post-operatively. The second will be a follow-up phone call scheduled at a minimum of 30 days and a maximum of 45 days post-operatively.

Conditions

• Laparoscopic Gynecological Surgical Procedures

Interventions

Type	Name	Description
DEVICE	Eximis CS (Contained Segmentation) System	The Eximis CS System is an integrated system consisting of a 900 mL Capture Bag, Inflation Mechanism, two Eximis Segmenters, and the Eximis RF Generator.

Timeline

• Start date: 2024-09-20
• Primary completion: 2025-09-01
• Completion: 2025-10-25
• First posted: 2024-08-27
• Last updated: 2025-10-30

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study