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NCT03573206 · ClinicalTrials.gov registry record · NA
AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)
A NA study of Surgical Wound, sponsored by Cardiva Medical.
- Completed
- Registry status
- NA
- Development phase
- 168
- Enrollment target
- 3
- Study locations
NCT03573206 is a NA study of Surgical Wound that has completed, run by Cardiva Medical. The registered enrollment target is 168 participants, above the 86-participant average among 17 other Surgical Wound trials with a reported enrollment target (95% higher). The trial reports 3 study locations across 3 states.
The verdict
NCT03573206, a NA study of Surgical Wound, has completed, sponsored by Cardiva Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 168 participants
- Enrollment target
- 3
- Study locations
Study Summary
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites at the completion of catheter-based procedures performed through 6-12 Fr introducer sheath, while allowing for one or more of the following: elimination of the Foley catheter, elimination of protamine, or allowing same (calendar) day discharge for the appropriate patient population.
Conditions Studied
Interventions
- DEVICE Cardiva Mid-Bore Venous Vascular Closure Device (VVCS)
Study Locations (3)
Georgia
- Emory St. Joseph's Hospital - Atlanta
New Jersey
- Valley Hospital - Ridgewood
Texas
- Texas Cardiac Arrhythmia Research Foundation - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2018-08-27 |
| Est. Completion | 2019-03-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03573206
The ClinicalTrials.gov registry entry for NCT03573206 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 168 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 86-participant average among 17 other Surgical Wound trials with a reported enrollment target (95% higher). The listed sponsor is Cardiva Medical, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Surgical Wound appearing as the primary indexed condition, and to 1 intervention - of which Cardiva Mid-Bore Venous Vascular Closure Device (VVCS) is the first listed.
NCT03573206 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Georgia, New Jersey, Texas.
Frequently Asked Questions
What is clinical trial NCT03573206 about?
NCT03573206 is a clinical study titled "AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)". The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites at the completion of catheter-based procedures performed through 6-12 Fr introducer sheath, while allowing for one or more of...
What is the current status of trial NCT03573206?
This trial is currently completed. It is a NA study. The enrollment target is 168 participants. The study started on 2018-08-27. Estimated completion is 2019-03-31.
What conditions does trial NCT03573206 study?
This clinical trial studies the following conditions: Surgical Wound.
What interventions are being tested in trial NCT03573206?
The interventions under investigation include: Cardiva Mid-Bore Venous Vascular Closure Device (VVCS) (DEVICE).
Who is sponsoring clinical trial NCT03573206?
This trial is sponsored by Cardiva Medical, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03573206 being conducted?
This trial has 3 study locations across Georgia, New Jersey, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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