Evaluation of the Eximis CS System for laparoscopic gynecological surgeries
Clinical Validation Study of the Eximis CS (Contained Segmentation) System
NA · Eximis Surgical · NCT06572163
This study is testing a new device called the Eximis CS System to see if it can safely and effectively help with removing uterine tissue during laparoscopic surgeries for women who haven't gone through menopause.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 21 Years to 49 Years |
| Sex | Female |
| Sponsor | Eximis Surgical (industry) |
| Locations | 4 sites (Celebration, Florida and 3 other locations) |
| Trial ID | NCT06572163 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and effectiveness of the Eximis CS System, a device designed for the containment, segmentation, and extraction of uterine tissue during laparoscopic hysterectomy or myomectomy procedures in pre-menopausal women. The study is prospective, multi-center, and single-arm, meaning all participants will receive the same intervention without a control group. Eligible subjects will undergo standard pre-operative and surgical care, with the unique aspect being the use of the Eximis CS System for tissue handling. Participants will be monitored for safety through follow-up visits occurring 30 to 45 days post-surgery.
Who should consider this trial
Good fit: Ideal candidates are pre-menopausal women scheduled for laparoscopic hysterectomy or myomectomy with specific tissue size requirements.
Not a fit: Patients who are post-menopausal or have known malignancies of gynecological origin may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and efficiency of laparoscopic gynecological surgeries by improving tissue handling.
How similar studies have performed: While similar approaches have been explored, the specific use of the Eximis CS System for this purpose is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Celebration, Florida and 3 other locations
- Advent Health, 410 Celebration Place — Celebration, Florida, United States (NOT_YET_RECRUITING)
- Rosemark Womens Care Specialists — Idaho Falls, Idaho, United States (RECRUITING)
- Maimonides Medical Center — Brooklyn, New York, United States (RECRUITING)
- Oregon Health and Science University School of Medicine — Portland, Oregon, United States (RECRUITING)
Study contacts
- Principal investigator: Scott Chudnoff, MD — Maimonides Medical Center
- Study coordinator: Hilary A Baldwin
- Email: hilary.baldwin@eximissurgical.com
- Phone: 6027332423
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Laparoscopic Gynecological Surgical Procedures