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NCT05067647 · ClinicalTrials.gov registry record · NA
A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures
A NA study, sponsored by Ethicon Endo-Surgery.
- Completed
- Registry status
- NA
- Development phase
- 94
- Enrollment target
NCT05067647: Completed NA study, sponsored by Ethicon Endo-Surgery.
NCT05067647 is a NA study that has completed, run by Ethicon Endo-Surgery. The registered enrollment target is 94 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05067647, a NA study, has completed, sponsored by Ethicon Endo-Surgery.
- COMPLETED
- Registry status
- NA
- Development phase
- 94 participants
- Enrollment target
Study 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).
Primary Outcome
A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (
Interventions
- DEVICE ENSEAL X1 Curved Jaw Tissue Sealer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2021-11-29 |
| Est. Completion | 2022-11-30 |
| Phase | NA |
What the finished NCT05067647 record still lists
NCT05067647 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which ENSEAL X1 Curved Jaw Tissue Sealer is the first listed.
NCT05067647 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05067647 about?
NCT05067647 is a clinical study titled "A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures". 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 is the current status of trial NCT05067647?
This trial is currently completed. It is a NA study. The enrollment target is 94 participants. The study started on 2021-11-29. Estimated completion is 2022-11-30.
What interventions are being tested in trial NCT05067647?
The interventions under investigation include: ENSEAL X1 Curved Jaw Tissue Sealer (DEVICE).
Who is sponsoring clinical trial NCT05067647?
This trial is sponsored by Ethicon Endo-Surgery, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05067647's enrollment target sits among peer trials
94 935th of 2000 higher than 1,064 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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