Clinical Research Directory
Browse clinical research sites, groups, and studies.
Absorbable Hemostatic Fluid Gelatin Trial
Sponsor: Medprin Regenerative Medical Technologies Co., Ltd.
Summary
This is a multicenter, single-blind, randomized controlled, non-inferiority trial evaluating the safety and efficacy of an absorbable hemostatic fluid gelatin for surgical hemostasis. Subjects are patients undergoing elective/semi-elective surgeries in General Surgery, Orthopedics, and Gynecology. The test group receives the investigational device, while the control group receives a marketed predicate device (SURGIFLO). The primary outcome is the 5-minute hemostasis success rate at the Target Bleeding Site (TBS).
Official title: A Multicenter, Single-Blind, Randomized Controlled Clinical Trial of the Safety and Efficacy of Absorbable Hemostatic Fluid Gelatin for Surgical Hemostasis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
324
Start Date
2026-09-08
Completion Date
2027-08-31
Last Updated
2026-09-21
Healthy Volunteers
No
Conditions
Interventions
Absorbable Hemostatic Fluid Gelatin
Composed of fluid gelatin preloaded in a syringe with catheter components; gelatin derived from porcine skin. Applied to TBS and covered with moist gauze during surgery.
Absorbable Hemostatic Fluid Gelatin SURGIFLO Haemostatic Matrix
This product is a flowable hemostatic material made from a porcine skin-derived gelatin matrix, intended to control bleeding from capillaries, veins, and small arteries during surgical procedures