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

NCT ID: NCT06572163

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2025-10-25

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Surgical

containment, segmentation, and extraction of uterine tissue

Group Type: OTHER

Eximis CS (Contained Segmentation) System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Planned laparoscopic hysterectomy or myomectomy. Tissue specimen size is greater than 6 cm in diameter, less than 13 cm in the longest dimension, and at most 10 cm in the second longest dimension, based on 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.

Subject is pregnant.

Intraoperative Exclusion: Abdominal wall thickness at the umbilicus incision site exceeds 6 cm.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Proxima CRO

INDUSTRY

Sponsor Role: collaborator

Eximis Surgical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Chudnoff, MD

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Locations

Advent Health, 410 Celebration Place

Celebration, Florida, United States

Rosemark Womens Care Specialists

Idaho Falls, Idaho, United States

Maimonides Medical Center

Brooklyn, New York, United States

Oregon Health and Science University School of Medicine

Portland, Oregon, United States

Countries

United States

Other Identifiers

CP2024-001

Identifier Type: -

Identifier Source: org_study_id