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

Launched by EXIMIS SURGICAL · Aug 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Eximis CS System, which is being tested for safety and effectiveness during laparoscopic gynecological surgeries, such as hysterectomy or myomectomy. The goal is to see if this system can help make these surgeries safer and more efficient for women.

To be eligible for the trial, participants must be planning to have one of these surgeries and have a specific size of tissue that needs to be removed. Women between the ages of 76 and 178 years old who have completed necessary pre-surgery evaluations and are willing to follow the study's guidelines can consider joining. Those with certain medical conditions, such as post-menopausal status or known gynecological cancer, will not be eligible. Participants can expect to undergo the surgery with the Eximis CS System and will need to attend follow-up appointments to ensure everything is going well. It’s important to know that this study is actively recruiting, which means they are looking for women who meet the criteria and are interested in participating.

Gender

FEMALE

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.