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NCT04763421 · ClinicalTrials.gov registry record · NA
A Prospective, Single-Arm Multi-Center Study of the ENSEAL X1 Curved Jaw Tissue Sealer in Select Procedures
A NA study, sponsored by Ethicon Endo-Surgery.
- Completed
- Registry status
- NA
- Development phase
- 145
- Enrollment target
NCT04763421: Completed NA study, sponsored by Ethicon Endo-Surgery.
NCT04763421 is a NA study that has completed, run by Ethicon Endo-Surgery. The registered enrollment target is 145 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04763421, a NA study, has completed, sponsored by Ethicon Endo-Surgery.
- COMPLETED
- Registry status
- NA
- Development phase
- 145 participants
- Enrollment target
Study Summary
This prospective, single-arm, multi-center study will collect clinical data in a post-market setting by procedure group (upper gastrointestinal \[GI\], lower GI, and gynecological). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 Curved Jaw and Generator G11 instructions for use.
Primary Outcome
Number of vessels with \<= Grade 3 hemostasis based on hemostasis grading scale were reported. 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)
Interventions
- DEVICE ENSEAL X1 Curved Jaw
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2021-04-22 |
| Est. Completion | 2023-09-29 |
| Phase | NA |
What the finished NCT04763421 record still lists
NCT04763421 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which ENSEAL X1 Curved Jaw is the first listed.
NCT04763421 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04763421 about?
NCT04763421 is a clinical study titled "A Prospective, Single-Arm Multi-Center Study of the ENSEAL X1 Curved Jaw Tissue Sealer in Select Procedures". This prospective, single-arm, multi-center study will collect clinical data in a post-market setting by procedure group (upper gastrointestinal \[GI\], lower GI, and gynecological). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the...
What is the current status of trial NCT04763421?
This trial is currently completed. It is a NA study. The enrollment target is 145 participants. The study started on 2021-04-22. Estimated completion is 2023-09-29.
What interventions are being tested in trial NCT04763421?
The interventions under investigation include: ENSEAL X1 Curved Jaw (DEVICE).
Who is sponsoring clinical trial NCT04763421?
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 NCT04763421's enrollment target sits among peer trials
145 705th of 2000 higher than 1,295 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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