Trials / Completed
CompletedNCT04734535
Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery
Prospective, Randomized, Controlled, Multicenter, Clinical Investigation Evaluating the Safety of HEMOBLAST™ Bellows in Spine Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Dilon Technologies Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HEMOBLAST™ Bellows | Intraoperative bleeding during epidural spine surgery will be treated with HEMOBLAST™ Bellows |
| DEVICE | absorbable gelatin sponge with thrombin | Intraoperative bleeding during epidural spine surgery will be treated with absorbable gelatin sponge with thrombin |
Timeline
- Start date
- 2021-03-08
- Primary completion
- 2024-02-05
- Completion
- 2024-02-05
- First posted
- 2021-02-02
- Last updated
- 2024-04-02
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04734535. Inclusion in this directory is not an endorsement.