Human Factors Actual-Use Clinical Protocol

NCT04799210 | Terminated DMC FDA Device

• 1 other identifier: CIP2020-001
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 7

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.

Conditions

Laparoscopic Gynecological Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of procedures successfully completed with use of the Eximis CS device.

  Through study completion, anticipated to be 4-6 months

• Number of Capture Bags with breach of containment.

  Through study completion, anticipated to be 4-6 months

• The number and severity of user adverse events caused by use error.

  Day of surgery

• The number and severity of subject adverse events caused by use error.

  Minimum 30 days (Standard of care follow-up 4-6 weeks)

• All other adverse events.

  Minimum 30 days (Standard of care follow-up 4-6 weeks)

Other Outcomes (7)

• 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

• Duration of the surgical procedure (from skin incision to skin closure).

  Day of surgery

• Length of incision (mm) used for the Eximis CS device at procedure end (removal of Eximis CS Capture Bag).

  Day of surgery

Study Arms (1)

Human Factors Actual Use

EXPERIMENTAL

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

Device: Eximis CS (Contained Segmentation) System

Interventions

Eximis CS (Contained Segmentation) System DEVICE

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

Also known as: Eximis CS, EX-900K-CLIN

Human Factors Actual Use

Eligibility Criteria

• Age: 21 Years - 49 Years
• Gender Eligibility Details: Pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eximis Surgical: lead

Study Sites (7)

Advanced Women's Health Institute

Greenwood Village, Colorado, 80111, United States

Location

AdventHealth Medical Group Gynecologic Surgery at Celebration

Celebration, Florida, 34747, United States

Location

Swor Women's Care

Sarasota, Florida, 34239, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Advanced Gynecologic Surgery Institute

Park Ridge, Illinois, 60068, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

ProMedica Health System

Sylvania, Ohio, 43560, United States

Location

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Sawsan As-Sanie, MD, MPH

  Women's Hospital, University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 16, 2021
• Study Start: September 16, 2021
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: February 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)