Clinical Validation Study of the Eximis CS (Contained Segmentation) System
- Conditions
- Laparoscopic Gynecological Surgical Procedures
- Registration Number
- NCT06572163
- Lead Sponsor
- Eximis Surgical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Female
- Target Recruitment
- 30
Inclusion Criteria:<br><br>Planned laparoscopic hysterectomy or myomectomy. Tissue specimen size is greater than 6<br>cm in diameter, less than 13 cm in the longest dimension, and at most 10 cm in the second<br>longest dimension, based on preoperative assessment.<br><br>Pre-operative evaluation, which may include imaging, cervical cancer screening, and<br>endometrial biopsy has been completed.<br><br>Signed informed consent. Willing to adhere to protocol requirements and complete<br>follow-up.<br><br>Exclusion Criteria:<br><br>Subject is post-menopausal, defined as amenorrhea >12 months in the absence of ovulation<br>suppression.<br><br>Known or suspected malignancy of gynecological origin as determined by standard clinical<br>practice.<br><br>Candidate for en bloc tissue removal, for example through the vagina or via a<br>mini-laparotomy incision.<br><br>Hemoglobin < 8 g/dl within 30 days prior to surgery. Subject has a current history of<br>undiagnosed genital bleeding Subject has an implanted electronic device where use of<br>radiofrequency (RF) energy would be contraindicated (e.g., pacemaker, internal<br>defibrillator).<br><br>Medical condition, surgical history, or intra-operative findings, which in the option of<br>the investigator, precludes utilization of the Eximis CS System.<br><br>Known allergy to polyurethane, polyethylene, thermoplastic fluoropolymer and/or<br>chlorinated polyvinyl chloride.<br><br>Concurrent participation in another therapeutic or interventional clinical trial with<br>investigational pharmaceutical agent(s) or medical device(s) that could impact evaluation<br>of this study as determined by the Investigator.<br><br>Inability to comply with the study procedures or follow-up in the opinion of the<br>investigator.<br><br>Subject is pregnant.<br><br>Intraoperative Exclusion: Abdominal wall thickness at the umbilicus incision site exceeds<br>6 cm.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Performance
- Secondary Outcome Measures
Name Time Method Usability