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NCT04149925 · ClinicalTrials.gov registry record
Endostapler Hemostasis Study
A clinical trial of Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale, sponsored by Lexington Medical.
- Completed
- Registry status
- 60
- Enrollment target
- 3
- Study locations
NCT04149925 is a study of Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale that has completed, run by Lexington Medical. The registered enrollment target is 60 participants. The trial reports 3 study locations across 1 state.
The verdict
NCT04149925, a study of Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale, has completed, sponsored by Lexington Medical.
- COMPLETED
- Registry status
- 60 participants
- Enrollment target
- 3
- Study locations
Study Summary
The goal of this prospective, multi-center, post-market study is to measure AEON™ Endostapler performance with the EASY/THICK MODE feature for laparoscopic bariatric surgery against the Echelon Flex™ Powered Stapler system from Ethicon. Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding through a third-party blinded primary outcome evaluator. The study will include 60 total consecutive cases of individuals undergoing a planned laparoscopic sleeve gastrectomy (LSG). The LSG procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care. Relevant data will be collected using the Data Collection sheet which should be filled out following each procedure by a member of the surgical or nursing team.
Conditions Studied
Interventions
- DEVICE AEON Endostapler
- DEVICE Echelon Flex Powered Stapler
Study Locations (3)
Louisiana
- Avala Hospital - Covington
- Crescent City Surgical Centre - Metairie
- Southern Surgical Hospital - Slidell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-10-22 |
| Est. Completion | 2020-02-14 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04149925
The ClinicalTrials.gov registry entry for NCT04149925 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lexington Medical, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale appearing as the primary indexed condition, and to 2 interventions - of which AEON Endostapler is the first listed.
NCT04149925 reports 3 study locations spanning 1 distinct geographic area - top geographies include Louisiana.
Frequently Asked Questions
What is clinical trial NCT04149925 about?
NCT04149925 is a clinical study titled "Endostapler Hemostasis Study". The goal of this prospective, multi-center, post-market study is to measure AEON™ Endostapler performance with the EASY/THICK MODE feature for laparoscopic bariatric surgery against the Echelon Flex™ Powered Stapler system from Ethicon. Stapler performance will be evaluated primarily by incidence an...
What is the current status of trial NCT04149925?
This trial is currently completed. The enrollment target is 60 participants. The study started on 2019-10-22. Estimated completion is 2020-02-14.
What conditions does trial NCT04149925 study?
This clinical trial studies the following conditions: Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale.
What interventions are being tested in trial NCT04149925?
The interventions under investigation include: AEON Endostapler (DEVICE), Echelon Flex Powered Stapler (DEVICE).
Who is sponsoring clinical trial NCT04149925?
This trial is sponsored by Lexington Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04149925 being conducted?
This trial has 3 study locations across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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