N/A
N=101
A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer
Colectomy; Gynecological; Thoracic
Bottom Line
View on ClinicalTrials.gov: NCT03441178 ↗Enrolled (actual)
101
Serious AEs
11.9%
Results posted
Sep 2020
Primary outcome: Primary: Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1 — 100.0; 94.2; 96.7; 96.2 Percentage of Vessels
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ENSEAL X1 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ethicon Endo-Surgery
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1 |
100.0; 94.2; 96.7; 96.2 | — |
| SECONDARY Hemostasis Grading Assessment for Each Vessel Transection |
63; 126; 81; 270; 4; 14 | — |
| SECONDARY Number of Grade 3 Vessels Needing ENSEAL X1 Touch-up |
0; 7; 1; 8 | — |
| SECONDARY Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used |
2; 0; 2; 2; 0; 2 | — |
Summary
This prospective, single-arm, multi-center, evaluation will collect clinical data in a post-market setting. The three types of procedures studied will be colectomy, gynecological, and thoracic. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 instructions for use.
Eligibility Criteria
Inclusion Criteria
- Elective procedure (colectomy, gynecological, or thoracic) where at least one vessel is planned to be transected by the ENSEAL X1 device per its instructions for use;
- Willingness to give consent and comply with all study-related evaluations and treatment schedule; and
- At least 18 years of age.
Exclusion Criteria
- Physical or psychological condition which would impair study participation; or
- Enrollment in a concurrent clinical study.
Data sourced from ClinicalTrials.gov (NCT03441178). 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.