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NCT03441178 · ClinicalTrials.gov registry record · NA
A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer
A NA study, sponsored by Ethicon Endo-Surgery.
- Completed
- Registry status
- NA
- Development phase
- 101
- Enrollment target
NCT03441178: Completed NA study, sponsored by Ethicon Endo-Surgery.
NCT03441178 is a NA study that has completed, run by Ethicon Endo-Surgery. The registered enrollment target is 101 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
NCT03441178, a NA study, has completed, sponsored by Ethicon Endo-Surgery.
- COMPLETED
- Registry status
- NA
- Development phase
- 101 participants
- Enrollment target
Study 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.
Primary Outcome
* 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 monopolar device and/or touch-ups with ENSEAL X1; * Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy pr
Interventions
- DEVICE ENSEAL X1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2018-03-13 |
| Est. Completion | 2019-08-30 |
| Phase | NA |
What the finished NCT03441178 record still lists
NCT03441178 is an interventional study that assigns participants to a tested intervention. The registered 101 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 (93% lower).
The record links to 0 conditions, and to 1 intervention - of which ENSEAL X1 is the first listed.
NCT03441178 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03441178 about?
NCT03441178 is a clinical study titled "A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer". 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 appr...
What is the current status of trial NCT03441178?
This trial is currently completed. It is a NA study. The enrollment target is 101 participants. The study started on 2018-03-13. Estimated completion is 2019-08-30.
What interventions are being tested in trial NCT03441178?
The interventions under investigation include: ENSEAL X1 (DEVICE).
Who is sponsoring clinical trial NCT03441178?
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 NCT03441178's enrollment target sits among peer trials
101 840th of 2000 higher than 1,161 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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