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Hemostatic Agent

HEMOBLAST Bellows for Postoperative Bleeding

N/A
Waitlist Available
Led By Joseph Schwab, MD
Research Sponsored by Dilon Technologies Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months follow-up
Awards & highlights

Study Summary

This trialis to assess the safety & efficacy of HEMOBLAST™ Bellows for use in spine surgery, with the goal of removing the neurosurgical exclusion from its approved indication.

Who is the study for?
This trial is for adults aged 22 or older who are having open, elective spine surgery and can consent to participate. They must not have infections at the surgery site, be on certain blood thinners, or have bleeding disorders. Pregnant women and those with severe health issues or allergies to bovine/porcine substances cannot join.Check my eligibility
What is being tested?
The trial tests HEMOBLAST Bellows—an absorbable gelatin sponge with thrombin—on patients during spine surgery to evaluate its safety and effectiveness in stopping bleeding where conventional methods may fail.See study design
What are the potential side effects?
Potential side effects of HEMOBLAST Bellows could include allergic reactions due to bovine/porcine components, infection risks at the surgical site, or complications related to bleeding if the product doesn't work as intended.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Unanticipated Adverse Device Effect (UADE)
Secondary outcome measures
Adverse events (AE)
Other outcome measures
Blood transfusions
Hemostatic function
Length of stay
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: investigationalExperimental Treatment1 Intervention
HEMOBLAST™ Bellows
Group II: controlActive Control1 Intervention
absorbable gelatin sponge with thrombin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HEMOBLAST™ Bellows
2021
N/A
~60

Find a Location

Who is running the clinical trial?

Dilon Technologies Inc.Lead Sponsor
Syneos HealthOTHER
172 Previous Clinical Trials
68,394 Total Patients Enrolled
Biom'Up France SASLead Sponsor
10 Previous Clinical Trials
588 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery
2021. "Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04734535.
~15 spots leftby Apr 2025
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