Status:
TERMINATED
Human Factors Actual-Use Clinical Protocol
Lead Sponsor:
Eximis Surgical
Conditions:
Laparoscopic Gynecological Surgery
Eligibility:
FEMALE
21-49 years
Phase:
NA
Brief Summary
The purpose of this study is to confirm device use safety and effectiveness of the Eximis CS (Contained Segmentation) System in actual use by representative users, use, and use environments as require...
Detailed Description
This is a prospective, multi-center, single-arm study to confirm device use safety and effectiveness in an actual use setting when utilized by gynecological surgeons during surgery for containment, se...
Eligibility Criteria
Inclusion
- Age \>/= 21 and \< 50 years.
- Planned laparoscopic hysterectomy or myomectomy.
- Tissue specimen is \<11 cm in maximum diameter based on standard 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
- 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 is \> 8 cm.
Key Trial Info
Start Date :
September 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04799210
Start Date
September 16 2021
End Date
December 13 2021
Last Update
February 14 2022
Active Locations (7)
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1
Advanced Women's Health Institute
Greenwood Village, Colorado, United States, 80111
2
AdventHealth Medical Group Gynecologic Surgery at Celebration
Celebration, Florida, United States, 34747
3
Swor Women's Care
Sarasota, Florida, United States, 34239
4
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201