Clinical trials

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).

This is a multicentre, prospective, open-label, single-arm, observational, post-market clinical follow-up registry study designed to observe the safety and performance of the Immiseal™ Dural Sealant System when used as an adjunct to standard methods of dural repair to provide watertight closure during neurosurgical procedures. Eligible adult subjects requiring dural repair after neurosurgical procedures or traumatic injury, for whom the investigator has made the clinical decision to use the device, will be enrolled and followed for approximately 100 ± 10 days after surgery.