Human Factors Actual-Use Clinical Protocol (CONTAIN)

Human Factors Actual-Use Confirmatory Validation Study of the Eximis CS (Contained Segmentation) System ("Contain" Study)

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.

Study Overview

• Status: Terminated
• Conditions: Laparoscopic Gynecological Surgery
• Intervention / Treatment: Device: Eximis CS (Contained Segmentation) System

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • Advanced Women's Health Institute
  • Florida
    • Celebration, Florida, United States, 34747
      • AdventHealth Medical Group Gynecologic Surgery at Celebration
    • Sarasota, Florida, United States, 34239
      • Swor Women's Care
  • Illinois
    • Evanston, Illinois, United States, 60201
      • NorthShore University HealthSystem
    • Park Ridge, Illinois, United States, 60068
      • Advanced Gynecologic Surgery Institute
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
  • Ohio
    • Sylvania, Ohio, United States, 43560
      • ProMedica Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Human Factors Actual Use; Confirm device use safety and effectiveness of the Eximis CS (Contained Segmentation) System in actual use	Device: Eximis CS (Contained Segmentation) System; Containment, segmentation and extraction of uterine tissue in pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications.; Other Names: Eximis CS; EX-900K-CLIN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of procedures where all critical tasks related to the Eximis CS are performed without serious use error.	Primary Endpoint	Through study completion, anticipated to be 4-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of procedures successfully completed with use of the Eximis CS device.	Secondary Endpoint	Through study completion, anticipated to be 4-6 months
Number of Capture Bags with breach of containment.	Secondary Endpoint	Through study completion, anticipated to be 4-6 months
The number and severity of user adverse events caused by use error.	Secondary Endpoint	Day of surgery
The number and severity of subject adverse events caused by use error.	Secondary Endpoint	Minimum 30 days (Standard of care follow-up 4-6 weeks)
All other adverse events.	Secondary Endpoint	Minimum 30 days (Standard of care follow-up 4-6 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	For Informal Evaluation	Day of surgery
Duration of the surgical procedure (from skin incision to skin closure).	For Informal Evaluation	Day of surgery
Length of incision (mm) used for the Eximis CS device at procedure end (removal of Eximis CS Capture Bag).	For Informal Evaluation	Day of surgery
Removed tissue weight (grams).	For Informal Evaluation	Day of surgery
Number of extracted tissue segments per subject.	For Informal Evaluation	Day of surgery
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.	For Informal Evaluation	Day of surgery
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.	For Informal Evaluation	Day of surgery

Collaborators and Investigators

• Sponsor: Eximis Surgical
• Investigators: Principal Investigator: Sawsan As-Sanie, MD, MPH, Women's Hospital, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2021
• Primary Completion (Actual): December 13, 2021
• Study Completion (Actual): December 13, 2021

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CIP2020-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes