Human Factors Actual-Use Clinical Protocol (CONTAIN)

Eximis Surgical

Status: Terminated

Conditions: Laparoscopic Gynecological Surgery

Treatments: Device: Eximis CS (Contained Segmentation) System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04799210

CIP2020-001

Details and patient eligibility

About

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 required for regulatory agency clearance for commercial use.

Full 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, segmentation and extraction of uterine tissue in pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications.

Enrollment: 3 patients

Sex: Female

Ages: 21 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age >/= 21 and < 50 years.
2. Planned laparoscopic hysterectomy or myomectomy.
3. Tissue specimen is <11 cm in maximum diameter based on standard preoperative assessment.
4. Pre-operative evaluation which may include imaging, cervical cancer screening, and endometrial biopsy has been completed.
5. Signed informed consent.
6. Willing to adhere to protocol requirements and complete follow-up.

Exclusion criteria

1. Subject is post-menopausal, defined as amenorrhea >12 months in the absence of ovulation suppression.
2. Known or suspected malignancy of gynecological origin as determined by standard clinical practice.
3. Candidate for en bloc tissue removal, for example through the vagina or via a mini-laparotomy incision.
4. Hemoglobin < 8 g/dl within 30 days prior to surgery.
5. Subject has a current history of undiagnosed genital bleeding.
6. Subject has an implanted electronic device where use of radiofrequency (RF) energy would be contraindicated (e.g., pacemaker, internal defibrillator).
7. Medical condition, surgical history, or intra-operative findings, which in the option of the investigator, precludes utilization of the Eximis CS System.
8. Known allergy to polyurethane, polyethylene, thermoplastic fluoropolymer and/or chlorinated polyvinyl chloride.
9. 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.
10. Inability to comply with the study procedures or follow-up in the opinion of the investigator.
11. Subject is pregnant.
12. Intraoperative Exclusion: Abdominal wall thickness at the umbilicus incision site is > 8 cm.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Human Factors Actual Use

Experimental group

Description:

Confirm device use safety and effectiveness of the Eximis CS (Contained Segmentation) System in actual use

Treatment:

Device: Eximis CS (Contained Segmentation) System