Absorbable Hemostatic Fluid Gelatin Trial

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE3

Enrollment: 324

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).

Eligibility Criteria

Inclusion Criteria: * 1\. Age ≥18 years; * 2\. Scheduled for elective/semi-elective surgery in General Surgery, Orthopedics, or Gynecology; * 3\. Signed informed consent. (Intra-op): 1. Presence of a suitable Target Bleeding Site (TBS). Exclusion Criteria: * 1\. Allergy to porcine gelatin or refusal of porcine-derived products; * 2\. INR\>1.5 or PLT\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07830797). StuddyBuddy aggregates publicly available trial information.