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NCT02307318 · ClinicalTrials.gov registry record · Phase 1
Heart and Hands Study II: A Retrospective Data Collection & Analysis Project
A Phase 1 study, sponsored by HealthEast Care System.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT02307318: Completed Phase 1 study, sponsored by HealthEast Care System.
NCT02307318 is a Phase 1 study that has completed, run by HealthEast Care System. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02307318, a Phase 1 study, has completed, sponsored by HealthEast Care System.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
A recent pilot study conducted at HealthEast found use of manual pressure with the SoftSeal hemostatic pad for 15 minutes was successful in 9 out of 10 people fully anticoagluated using 4 French radial sheath. There was no evidence of radial artery occlusion in this small sample and bleeding was limited to grade 1. This evidence supports a larger retrospective study to confirm these results and define an alternative to the TR band use post radial artery access for cardiac catheterization. Primary Objective Determine the incidence of arterial bleeding after real-world use of SoftSeal hemostatic device at a transradial access site with a 4 French system with with manual pressure by compression of the ulnar artery. Secondary Objective Determine the incidence of thrombosis at the access site in all subjects as presence of thrombus in the radial artery by reverse barbeau test; the incidence of changes in circulation, movement and sensation (CMS) in the hand and wrist on the impacted hand; and the incidence of hematoma and ecchymosis, assessed just prior to discharge.
Primary Outcome
Number of patients who experience arterial bleeding after use of the Softseal hemostatic device and manual compression at the transradial access site as measured by observation.
Interventions
- DEVICE SoftSeal Hemostatic Pad
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2014-11 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
What the finished NCT02307318 record still lists
NCT02307318 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 1 intervention - of which SoftSeal Hemostatic Pad is the first listed.
NCT02307318 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02307318 about?
NCT02307318 is a clinical study titled "Heart and Hands Study II: A Retrospective Data Collection & Analysis Project". A recent pilot study conducted at HealthEast found use of manual pressure with the SoftSeal hemostatic pad for 15 minutes was successful in 9 out of 10 people fully anticoagluated using 4 French radial sheath. There was no evidence of radial artery occlusion in this small sample and bleeding was lim...
What is the current status of trial NCT02307318?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2014-11. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02307318?
The interventions under investigation include: SoftSeal Hemostatic Pad (DEVICE).
Who is sponsoring clinical trial NCT02307318?
This trial is sponsored by HealthEast Care System, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02307318's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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