Human Factors Actual-Use Clinical Protocol

Laparoscopic Gynecological Surgery Clinical Trial

— CONTAIN  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04799210
• Other study ID #: CIP2020-001
• Status: Terminated
• Phase: N/A
• Start date: September 16, 2021
• Est. completion date: December 13, 2021

Study information

• Verified date: February 2022
• Source: Eximis Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Gynecological Surgery

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	AdventHealth Medical Group Gynecologic Surgery at Celebration	Celebration	Florida
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	Advanced Women's Health Institute	Greenwood Village	Colorado
United States	Advanced Gynecologic Surgery Institute	Park Ridge	Illinois
United States	Swor Women's Care	Sarasota	Florida
United States	ProMedica Health System	Sylvania	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Eximis Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Duration of the surgical procedure (from skin incision to skin closure).	For Informal Evaluation	Day of surgery
Other	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
Other	Removed tissue weight (grams).	For Informal Evaluation	Day of surgery
Other	Number of extracted tissue segments per subject.	For Informal Evaluation	Day of surgery
Other	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
Other	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
Primary	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	Number of procedures successfully completed with use of the Eximis CS device.	Secondary Endpoint	Through study completion, anticipated to be 4-6 months
Secondary	Number of Capture Bags with breach of containment.	Secondary Endpoint	Through study completion, anticipated to be 4-6 months
Secondary	The number and severity of user adverse events caused by use error.	Secondary Endpoint	Day of surgery
Secondary	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)
Secondary	All other adverse events.	Secondary Endpoint	Minimum 30 days (Standard of care follow-up 4-6 weeks)