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CONTAIN: Human Factors Actual-Use Clinical Protocol

Sponsor
Eximis Surgical (Industry)
Overall Status
Terminated
CT.gov ID
NCT04799210
Collaborator
(none)
3
Enrollment
7
Locations
1
Arm
2.9
Actual Duration (Months)
0.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Eximis CS (Contained Segmentation) System
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single Group AssignmentSingle Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Human Factors Actual-Use Confirmatory Validation Study of the Eximis CS (Contained Segmentation) System ("Contain" Study)
Actual Study Start Date :
Sep 16, 2021
Actual Primary Completion Date :
Dec 13, 2021
Actual Study Completion Date :
Dec 13, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The number of procedures where all critical tasks related to the Eximis CS are performed without serious use error. [Through study completion, anticipated to be 4-6 months]

      Primary Endpoint

    Secondary Outcome Measures

    1. Number of procedures successfully completed with use of the Eximis CS device. [Through study completion, anticipated to be 4-6 months]

      Secondary Endpoint

    2. Number of Capture Bags with breach of containment. [Through study completion, anticipated to be 4-6 months]

      Secondary Endpoint

    3. The number and severity of user adverse events caused by use error. [Day of surgery]

      Secondary Endpoint

    4. The number and severity of subject adverse events caused by use error. [Minimum 30 days (Standard of care follow-up 4-6 weeks)]

      Secondary Endpoint

    5. All other adverse events. [Minimum 30 days (Standard of care follow-up 4-6 weeks)]

      Secondary Endpoint

    Other Outcome Measures

    1. 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). [Day of surgery]

      For Informal Evaluation

    2. Duration of the surgical procedure (from skin incision to skin closure). [Day of surgery]

      For Informal Evaluation

    3. Length of incision (mm) used for the Eximis CS device at procedure end (removal of Eximis CS Capture Bag). [Day of surgery]

      For Informal Evaluation

    4. Removed tissue weight (grams). [Day of surgery]

      For Informal Evaluation

    5. Number of extracted tissue segments per subject. [Day of surgery]

      For Informal Evaluation

    6. 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. [Day of surgery]

      For Informal Evaluation

    7. 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. [Day of surgery]

      For Informal Evaluation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 49 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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
    5 Advanced Gynecologic Surgery Institute Park Ridge Illinois United States 60068
    6 University of Michigan Health System Ann Arbor Michigan United States 48109
    7 ProMedica Health System Sylvania Ohio United States 43560

    Sponsors and Collaborators

    • Eximis Surgical

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eximis Surgical
    ClinicalTrials.gov Identifier:
    NCT04799210
    Other Study ID Numbers:
    • CIP2020-001
    First Posted:
    Mar 16, 2021
    Last Update Posted:
    Feb 14, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes

    Study Results

    No Results Posted as of Feb 14, 2022