Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04799210
Status:
TERMINATED
Last Update Posted:
2022-02-14
First Post:
2021-03-10
Brief Title:
Human Factors Actual-Use Clinical Protocol
Sponsor:
Eximis Surgical
Organization:
Eximis Surgical
Study Overview
Official Title:
Human Factors Actual-Use Confirmatory Validation Study of the Eximis CS Contained Segmentation System Contain Study
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Device performance was not as anticipated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONTAIN
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None