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

NCT06572163 | Completed FDA Device

• 1 other identifier: CP2024-001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Laparoscopic Gynecological Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• Performance

  Percentage of procedures successfully completed with use of the Eximis CS device per the Instructions for Use and without breach of the containment bag.

  2 months

Secondary Outcomes (1)

• Usability

  2 months

Other Outcomes (1)

• Adverse Events

  2 months

Study Arms (1)

Surgical

OTHER

containment, segmentation, and extraction of uterine tissue

Device: Eximis CS (Contained Segmentation) System

Interventions

Eximis CS (Contained Segmentation) System 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.

Surgical

Eligibility Criteria

• Age: 21 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• Eximis Surgical: lead
• Proxima CRO: collaborator

Study Sites (4)

Advent Health, 410 Celebration Place

Celebration, Florida, 34747, United States

Location

Rosemark Womens Care Specialists

Idaho Falls, Idaho, 83404, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Oregon Health and Science University School of Medicine

Portland, Oregon, 97239, United States

Location

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Scott Chudnoff, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 27, 2024
• Study Start: September 20, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 25, 2025
• Last Updated: October 30, 2025

Record last verified: 2025-10

Locations

US (4)