N/A
Completed N=94
A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures
Thoracic Procedure · Urologic Procedure · Ear, Nose and Throat Procedure
Source: ClinicalTrials.gov NCT05067647 ↗
Enrolled (actual)
94
Serious AEs
4.3%
Results posted
Dec 2023
Primary outcomePrimary: Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale — 108 vessels transected
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale |
108 | — |
| PRIMARY Number of Participants With at Least One Device-related Adverse Events (AEs) |
4 | — |
| SECONDARY Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score |
1; 2; 0; 6; 4 | — |
| SECONDARY Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score |
1; 1; 6; 21; 7 | — |
| SECONDARY Number of Participants With Tissue Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score |
2; 1; 10; 33; 11 | — |
| SECONDARY Number of Participants With Tissue Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score |
1; 0; 3; 13; 10 | — |
| SECONDARY Number of Participants With Tissue Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score |
1; 3; 6; 39; 9 | — |
| SECONDARY Number of Participants With Tissue Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score |
0; 6; 8; 31; 7 | — |
| SECONDARY Number of Vessels With Hemostasis (Grade 1 to 4) Based on Grading Scale |
104; 0; 4; 4 | — |
| SECONDARY Percentage of Grade 4 Vessel Transections Requiring Hemostasis Measures Such as Sutures and Hemoclips |
50.0; 50.0 | — |
Eligibility Criteria
Inclusion Criteria
- 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)
- Willingness to give consent and comply with all study-related evaluations and treatment schedule
- At least 18 years of age
Exclusion Criteria
- Physical or psychological condition which would impair study participation
- Enrollment in a concurrent interventional clinical study that could impact the study endpoints
Data sourced from ClinicalTrials.gov (NCT05067647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.