Status:
RECRUITING
A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery
Lead Sponsor:
Ethicon, Inc.
Conditions:
Hemostasis
Hemostatic Techniques
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion Criteria:
Pre-operative
- Participant is scheduled to undergo an elective open, abdominal, retroperitoneal, pelvic, thoracic (non-cardiac) or extremity surgical procedure
- Participant is willing and able to give written informed consent for the clinical investigation participation
Intra-operative
- Participant in whom the Investigator can identify and visualize a target bleeding site for which any applicable conventional means for hemostasis (e.g., suture, ligature, or cautery) are ineffective or impractical
- Target Bleeding Site is identified to originate from soft tissue, defined as organ bed, loose areolar tissue, fat, lymphatic tissue/lymph node beds, and muscle
- The choice is made to use a hemostatic agent to stop the bleeding, and there is the ability to apply pressure on the surface of the hemostatic agent to achieve hemostasis
- Participant has a Target Bleeding Site with a SBSS score of 1, 2, or 3 (e.g., reflecting minimal, mild, or moderate bleeding severities)
Exclusion Criteria:
Pre-operative
- Participant is scheduled for another planned surgery within the follow-up period and the subsequent surgery would jeopardize the ETHIZIA or SURGICEL Original application
- Participant is taking multiple antithrombotic therapies in therapeutic dosage up to the time of surgery, but allowing exclusive use of acetylsalicylic acid
- Participant has an active or suspected infection at the bleeding site
- Participant is pregnant, planning on becoming pregnant, or actively breastfeeding during the 28-day follow-up period
Intra-operative
- Target bleeding site is identified to originate from parenchymal organ tissue, cardiovascular (anastomotic or cardiovascular repair sites) tissue, or is in proximity to a foramina in bone, or areas of bony confine
- Target bleeding site is from a large defect in an artery or vein that requires vascular reconstruction with maintenance of vessel patency
Key Trial Info
Start Date :
April 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06664788
Start Date
April 16 2025
End Date
April 30 2026
Last Update
April 13 2026
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Keck Hospital of USC
Los Angeles, California, United States, 90033
2
Washington University Barnes Jewish Hospital
St Louis, Missouri, United States, 63110
3
Capital Health Medical Center - Hopewell
Pennington, New Jersey, United States, 08534
4
New York Presbyterian - Weill Cornell Medical Ctr
New York, New York, United States, 10065