Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01297322 · ClinicalTrials.gov registry record · NA
RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)
A NA study of Surgical Wound, sponsored by Cardiva Medical.
- Completed
- Registry status
- NA
- Development phase
- 420
- Enrollment target
- 20
- Study locations
NCT01297322 is a NA study of Surgical Wound that has completed, run by Cardiva Medical. The registered enrollment target is 420 participants, above the 71-participant average among 17 other Surgical Wound trials with a reported enrollment target (492% higher). The trial reports 20 study locations across 17 states.
The verdict
NCT01297322, a NA study of Surgical Wound, has completed, sponsored by Cardiva Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 420 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites. Hypothesis: The Cardiva VASCADE™ VCS provides times to hemostasis (TTH) and time to ambulation (TTA) results that are less than manual compression by a clinically meaningful and statistically significant margin. The rate of major access site-related complications with the Cardiva VASCADE™ VCS is non-inferior to the major complication rates of manual compression for sealing femoral arterial access sites.
Conditions Studied
Interventions
- OTHER Manual compression
- DEVICE Cardiva VASCADE™ Vascular Closure System
Study Locations (20)
Louisiana
- Terrebonne General Medical Center - Houma
- Lafayette General Medical Center - Lafayette
New York
- Winthrop University Hospital - Mineola
- New York-Presbyterian Hospital - New York
Virginia
- Sentara Norfolk General Hospital - Norfolk
- Virginia Commonwealth University Medical Center - Richmond
Alabama
- Thomas Hospital - Fairhope
Delaware
- Christiana Care - Newark
Florida
- Holmes Regional Medical Center - Melbourne
Illinois
- St. John's Prairie Heart - Springfield
Indiana
- St. Vincent's Heart Center of Indiana - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01297322
The ClinicalTrials.gov registry entry for NCT01297322 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 71-participant average among 17 other Surgical Wound trials with a reported enrollment target (492% 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 2 interventions - of which Manual compression is the first listed.
NCT01297322 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Louisiana, New York, Virginia.
Frequently Asked Questions
What is clinical trial NCT01297322 about?
NCT01297322 is a clinical study titled "RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)". The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites. Hypothesis: The Cardiva VASCADE™ VCS provides times to hemostasis (TTH) and time to ambulation (TTA) results that are less than m...
What is the current status of trial NCT01297322?
This trial is currently completed. It is a NA study. The enrollment target is 420 participants. The study started on 2011-09. Estimated completion is 2012-07.
What conditions does trial NCT01297322 study?
This clinical trial studies the following conditions: Surgical Wound.
What interventions are being tested in trial NCT01297322?
The interventions under investigation include: Manual compression (OTHER), Cardiva VASCADE™ Vascular Closure System (DEVICE).
Who is sponsoring clinical trial NCT01297322?
This trial is sponsored by Cardiva Medical, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01297322 being conducted?
This trial has 20 study locations across Alabama, Delaware, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Surgical Wound
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Early Versus Delayed Bathing of Orthopaedic Surgical Wounds
RECRUITING · NA
-
Multicenter Single-arm Trial to Investigate Clinical Outcomes When Cohealyx™ is Used for Full Thickness Wounds
ACTIVE NOT RECRUITING · NA
-
Influence of Sun Protection and Linear Repair of Cutaneous Surgical Defects
ACTIVE NOT RECRUITING · NA
-
Suture Closure Trial
ACTIVE NOT RECRUITING · NA
-
Randomized Controlled Trial to Investigate Clinical Outcomes and Associated Costs When PermeaDerm is Used as Temporary Dressing for Surgical Wounds
ACTIVE NOT RECRUITING · NA
-
Continuous Diffusion of Oxygen Treatment for Incision Wounds
COMPLETED · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.