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NCT03654560 · ClinicalTrials.gov registry record · NA
Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting
A NA study of Bleeding and Hemostasis, sponsored by United Health Products.
- Completed
- Registry status
- NA
- Development phase
- 236
- Enrollment target
- 1
- Study location
NCT03654560: Completed NA study of Bleeding and Hemostasis, sponsored by United Health Products.
NCT03654560 is a NA study of Bleeding and Hemostasis that has completed, run by United Health Products. The registered enrollment target is 236 participants, below the 1,475-participant average among 23 other Bleeding trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03654560, a NA study of Bleeding and Hemostasis, has completed, sponsored by United Health Products.
- COMPLETED
- Registry status
- NA
- Development phase
- 236 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to assess efficacy and safety of HemoStyp as an adjunct for management of secondary hemostasis in the operative setting.
Primary Outcome
The time to hemostasis was measured from start of study treatment to the achievement of hemostasis at the target bleeding site (TBS), or to the end of the 10-minute observation period. The time to hemostasis was considered as censored at the end of the 10-minute observation period. Time to hemostasis was quantified in minutes according to its nominal time point. When re-bleeding occurred, and the cessation of bleeding is again achieved at a later time point, the effective time to hemostasis was
Conditions Studied
Interventions
- DEVICE HemoStyp
- DEVICE Surgicel
Study Locations (1)
California
- Raymond Schaerf - Burbank
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2018-12-28 |
| Est. Completion | 2019-09-12 |
| Phase | NA |
What the finished NCT03654560 record still lists
NCT03654560 is an interventional study that assigns participants to a tested intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap, below the 1,475-participant average among 23 other Bleeding trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Bleeding appearing as the primary indexed condition, and to 2 interventions - of which HemoStyp is the first listed.
NCT03654560 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03654560 about?
NCT03654560 is a clinical study titled "Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting". The purpose of the study is to assess efficacy and safety of HemoStyp as an adjunct for management of secondary hemostasis in the operative setting.
What is the current status of trial NCT03654560?
This trial is currently completed. It is a NA study. The enrollment target is 236 participants. The study started on 2018-12-28. Estimated completion is 2019-09-12.
What conditions does trial NCT03654560 study?
This clinical trial studies the following conditions: Bleeding, Hemostasis.
What interventions are being tested in trial NCT03654560?
The interventions under investigation include: HemoStyp (DEVICE), Surgicel (DEVICE).
Who is sponsoring clinical trial NCT03654560?
This trial is sponsored by United Health Products, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03654560 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03654560's enrollment target sits among peer trials
236 12th of 23 higher than 12 of 23 other Bleeding trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bleeding 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.
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