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NCT04734535 · ClinicalTrials.gov registry record · NA
Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery
A NA study of Surgical Bleeding, sponsored by Dilon Technologies.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 5
- Study locations
NCT04734535: Completed NA study of Surgical Bleeding, sponsored by Dilon Technologies.
NCT04734535 is a NA study of Surgical Bleeding that has completed, run by Dilon Technologies. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04734535, a NA study of Surgical Bleeding, has completed, sponsored by Dilon Technologies.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
incidence of UADE, for subjects treated with HEMOBLAST™, as determined by the Independent Data Monitoring Committee (IDMC).
Conditions Studied
Interventions
- DEVICE HEMOBLAST™ Bellows
- DEVICE absorbable gelatin sponge with thrombin
Study Locations (5)
California
- University of Southern California - Los Angeles
Indiana
- Indiana Spine Group - Carmel
Maryland
- Johns Hopkins Bayview Medical Center - Baltimore
Massachusetts
- Massachusetts General Hospital - Boston
Virginia
- Spectrum Medical Inc - Danville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-03-08 |
| Est. Completion | 2024-02-05 |
| Phase | NA |
What the finished NCT04734535 record still lists
NCT04734535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Surgical Bleeding appearing as the primary indexed condition, and to 2 interventions - of which HEMOBLAST™ Bellows is the first listed.
NCT04734535 lists 5 locations in 5 states (California, Indiana, Maryland).
Frequently Asked Questions
What is clinical trial NCT04734535 about?
NCT04734535 is a clinical study titled "Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery". 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 sp...
What is the current status of trial NCT04734535?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2021-03-08. Estimated completion is 2024-02-05.
What conditions does trial NCT04734535 study?
This clinical trial studies the following conditions: Surgical Bleeding.
What interventions are being tested in trial NCT04734535?
The interventions under investigation include: HEMOBLAST™ Bellows (DEVICE), absorbable gelatin sponge with thrombin (DEVICE).
Who is sponsoring clinical trial NCT04734535?
This trial is sponsored by Dilon Technologies, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04734535 being conducted?
This trial has 5 study locations across California, Indiana, Maryland, Massachusetts, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04734535's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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