Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

The purpose of this clinical investigation in open, elective, spine surgery is to collect data to support the removal of the neurosurgical exclusion from the currently approved indication for the use of HEMOBLAST™ Bellows. This study is primarily designed to assess safety of the device for use in spine surgery, although efficacy information will also be captured and reported.

See also
Status	Clinical Trial	Phase
Completed	`NCT02284256` - A Safety and Efficacy Study Comparing Fibrocaps and Tachosil in Hepatic Surgery	Phase 3
Completed	`NCT01653769` - CoSeal for Hemostasis of Aortic Anastamoses	N/A
Terminated	`NCT02117349` - Topical Raplixa for Surgical Bleeding in Children	Phase 2

NCT number	NCT04734535
Study type	Interventional
Source	Dilon Technologies Inc.
Contact
Status	Completed
Phase	N/A
Start date	March 8, 2021
Completion date	February 5, 2024

Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms