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NCT06664788 · ClinicalTrials.gov registry record · NA
A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery
A NA study of Hemostasis and Hemostatic Techniques, sponsored by Ethicon.
- Recruiting
- Registry status
- NA
- Development phase
- 108
- Enrollment target
- 8
- Study locations
NCT06664788: Recruiting NA study of Hemostasis and Hemostatic Techniques, sponsored by Ethicon.
NCT06664788 is a NA study of Hemostasis and Hemostatic Techniques that is actively recruiting participants, run by Ethicon. The registered enrollment target is 108 participants, below the 382-participant average among 7 other Hemostasis trials with a reported enrollment target (72% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06664788, a NA study of Hemostasis and Hemostatic Techniques, is actively recruiting participants, sponsored by Ethicon.
- RECRUITING
- Registry status
- NA
- Development phase
- 108 participants
- Enrollment target
- 8
- Study locations
Study Summary
The objective of this clinical investigation is to evaluate the safety and efficacy of ETHIZIA to control minimal, mild, or moderate soft tissue bleeding during open surgery when compared to SURGICEL Original in the percentage of cases achieving hemostasis at 3 minutes after product application, and without re-bleeding up to 10 minutes after application.
Primary Outcome
Cases achieving hemostasis at 3 minutes following product application \& with no rebleeding up to 10 minutes following application at the target bleeding site (first bleeding site treated) will be determined by Surface Bleeding Severity Scale (SBSS). SBSS provides a clinically validated score for assessment of bleeding at the target site, and consists of 6 scores (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, not immediately life-threatening, 5 = extreme, immediately life-threatenin
Conditions Studied
Interventions
- DEVICE ETHIZIA
- DEVICE SURGICEL Original
Study Locations (8)
Other
- UMC Radboud - Nijmegen
- UMC Radboud - Nijmegen
California
- Keck Hospital of USC - Los Angeles
Missouri
- Washington University Barnes Jewish Hospital - St Louis
New Jersey
- Capital Health Medical Center - Hopewell - Pennington
New York
- New York Presbyterian - Weill Cornell Medical Ctr - New York
Texas
- UT Health East Texas EMS Air 1 - Tyler
Utah
- Intermountain Medical Center - Murray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2025-04-16 |
| Est. Completion | 2026-04-30 |
| Phase | NA |
What NCT06664788 shows while recruiting
NCT06664788 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 382-participant average among 7 other Hemostasis trials with a reported enrollment target (72% lower).
The record links to 2 conditions, with Hemostasis appearing as the primary indexed condition, and to 2 interventions - of which ETHIZIA is the first listed.
NCT06664788 lists 8 locations in 7 states (Other, California, Missouri).
Frequently Asked Questions
What is clinical trial NCT06664788 about?
NCT06664788 is a clinical study titled "A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery". The objective of this clinical investigation is to evaluate the safety and efficacy of ETHIZIA to control minimal, mild, or moderate soft tissue bleeding during open surgery when compared to SURGICEL Original in the percentage of cases achieving hemostasis at 3 minutes after product application, and...
What is the current status of trial NCT06664788?
This trial is currently recruiting. It is a NA study. The enrollment target is 108 participants. The study started on 2025-04-16. Estimated completion is 2026-04-30.
What conditions does trial NCT06664788 study?
This clinical trial studies the following conditions: Hemostasis, Hemostatic Techniques.
What interventions are being tested in trial NCT06664788?
The interventions under investigation include: ETHIZIA (DEVICE), SURGICEL Original (DEVICE).
Who is sponsoring clinical trial NCT06664788?
This trial is sponsored by Ethicon, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06664788 being conducted?
This trial has 8 study locations across California, Missouri, New Jersey, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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