Human Factors Actual-Use Clinical Protocol — CONTAIN

Laparoscopic Gynecological Surgery Clinical Trial

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

Status Terminated

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.

Clinical Trial 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

Related Conditions & MeSH terms

Laparoscopic Gynecological Surgery

Clinical Trial Details

NCT number	NCT04799210
Study type	Interventional
Source	Eximis Surgical
Contact
Status	Terminated
Phase	N/A
Start date	September 16, 2021
Completion date	December 13, 2021

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT03845608` - Analgesic Effect of Pulmonary Recruitment and Intraperitoneal Hydrocortisone in Laparoscopic Gynecological Surgery	Phase 4
Completed	`NCT05489796` - Bellomic PCA in Laparoscopic Gynecologic Surgery	N/A
Recruiting	`NCT05936671` - EEG and ANI Guided Anesthesia and Quality of Recovery	N/A
Withdrawn	`NCT01955798` - Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery	N/A