A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures
Sponsored by Ethicon Endo-Surgery
About this trial
Last updated 2 years ago
Study ID
ENG_2020_04
Status
Completed
Type
Interventional
Phase
N/A
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 3 years ago
What is this trial about?
The purpose of this study is to demonstrate the acceptable performance and safety of the
ENSEAL X1 curved jaw tissue sealer and Ethicon endo-surgery generator G11 (GEN11) devices
when used per the instructions for use (IFU).
What are the participation requirements?
Inclusion Criteria
1. Primary laparoscopic or open procedure (thoracic, urologic or ear, nose, and throat [ENT]) where at least one vessel is planned to be transected by the ENSEAL X1 curved jaw tissue sealer (ENSEAL X1) device per the Instructions for use (IFU)
2. Willingness to give consent and comply with all study-related evaluations and treatment schedule
3. At least 18 years of age
Exclusion Criteria
1. Physical or psychological condition which would impair study participation
2. Enrollment in a concurrent interventional clinical study that could impact the study endpoints