Clinical trial NCT04799210: Human Factors Actual-Use Clinical Protocol
Official title: Human Factors Actual-Use Confirmatory Validation Study of the Eximis CS (Contained Segmentation) System ("Contain" Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Laparoscopic Gynecological Surgery
Lead sponsor: Eximis Surgical
Sponsor class: INDUSTRY
First posted: 2021-03-16
Enrollment: 3
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

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 required for regulatory agency clearance for commercial use.

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

Eligibility criteria: 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.

Primary outcomes:
measure: The number of procedures where all critical tasks related to the Eximis CS are performed without serious use error.
timeFrame: Through study completion, anticipated to be 4-6 months
Secondary outcomes:
measure: Number of procedures successfully completed with use of the Eximis CS device.
timeFrame: Through study completion, anticipated to be 4-6 months
measure: Number of Capture Bags with breach of containment.
timeFrame: Through study completion, anticipated to be 4-6 months
measure: The number and severity of user adverse events caused by use error.
timeFrame: Day of surgery
measure: The number and severity of subject adverse events caused by use error.
timeFrame: Minimum 30 days (Standard of care follow-up 4-6 weeks)
measure: All other adverse events.
timeFrame: Minimum 30 days (Standard of care follow-up 4-6 weeks)
Other outcomes:
measure: Duration of the segmentation/extraction procedure (from insertion of the Eximis CS deployment instrument into the abdomen until removal of the Eximis CS Capture Bag from the abdomen).
timeFrame: Day of surgery
measure: Duration of the surgical procedure (from skin incision to skin closure).
timeFrame: Day of surgery
measure: Length of incision (mm) used for the Eximis CS device at procedure end (removal of Eximis CS Capture Bag).
timeFrame: Day of surgery
measure: Removed tissue weight (grams).
timeFrame: Day of surgery
measure: Number of extracted tissue segments per subject.
timeFrame: Day of surgery
measure: The size (mm) of the largest segment will be recorded, defined as the segment with the largest cross-sectional area of the surface that is parallel with the incision opening.
timeFrame: Day of surgery
measure: Subject's pathology results of the extracted tissue and pathologist assessment of radiofrequency (RF) energy impact to the tissue, if any, from use of the Eximis CS device.
timeFrame: Day of surgery
Locations:
city: Greenwood Village
country: United States
facility: Advanced Women's Health Institute
state: Colorado
city: Celebration
country: United States
facility: AdventHealth Medical Group Gynecologic Surgery at Celebration
state: Florida
city: Sarasota
country: United States
facility: Swor Women's Care
state: Florida
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Park Ridge
country: United States
facility: Advanced Gynecologic Surgery Institute
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Sylvania
country: United States
facility: ProMedica Health System
state: Ohio
Study officials:
affiliation: Women's Hospital, University of Michigan
name: Sawsan As-Sanie, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: