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NCT02908880 · ClinicalTrials.gov registry record · NA
MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study
A NA study of Femoral Arteriotomy Closure, sponsored by Essential Medical.
- Completed
- Registry status
- NA
- Development phase
- 263
- Enrollment target
- 19
- Study locations
NCT02908880: Completed NA study of Femoral Arteriotomy Closure, sponsored by Essential Medical.
NCT02908880 is a NA study of Femoral Arteriotomy Closure that has completed, run by Essential Medical. The registered enrollment target is 263 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). The trial reports 19 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02908880, a NA study of Femoral Arteriotomy Closure, has completed, sponsored by Essential Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 263 participants
- Enrollment target
- 19
- Study locations
Study Summary
Research study which tests the safety and effectiveness of a new vascular closure device to close the femoral access puncture that is created in patients who require this form of access in order to perform the planned procedure. The MANTA device is expected to seal the femoral access puncture in less than 1 minute. This may result in less blood loss and a shorter time to walking compared to alternative closure means. Use of the MANTA device in this study is experimental. All other parts of the procedure involve standard medical care.
Primary Outcome
The elapsed time between withdrawal of MANTA sheath/device from artery and first observed and confirmed arterial hemostasis (no or minimal subcutaneous oozing and the absence of expanding or developing hematoma).
Conditions Studied
Interventions
- DEVICE MANTA vascular closure device
Study Locations (19)
Pennsylvania
- Hershey Medical Center - Hershey
- Temple University Hospital - Philadelphia
- Lankenau Heart Group - Wynnewood
Texas
- Houston Methodist - Houston
- St. Luke's Hospital - Texas Heart - Houston
- The Heart Hospital Baylor Plano - Plano
California
- San Diego VA Medical Center - San Diego
District of Columbia
- Washington Hospital Center - Washington D.C.
Illinois
- Evanston Hospital - Evanston
Indiana
- St. Vincent Heart Center - Indianapolis
Michigan
- Henry Ford - Detroit
Missouri
- St. Luke Hospital (Mid America Heart) - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 263 participants |
| Start Date | 2016-12 |
| Est. Completion | 2017-12 |
| Phase | NA |
What the finished NCT02908880 record still lists
NCT02908880 is an interventional study that assigns participants to a tested intervention. The registered 263 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Femoral Arteriotomy Closure appearing as the primary indexed condition, and to 1 intervention - of which MANTA vascular closure device is the first listed.
NCT02908880 lists 19 locations in 15 states (Pennsylvania, Texas, California).
Frequently Asked Questions
What is clinical trial NCT02908880 about?
NCT02908880 is a clinical study titled "MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study". Research study which tests the safety and effectiveness of a new vascular closure device to close the femoral access puncture that is created in patients who require this form of access in order to perform the planned procedure. The MANTA device is expected to seal the femoral access puncture in les...
What is the current status of trial NCT02908880?
This trial is currently completed. It is a NA study. The enrollment target is 263 participants. The study started on 2016-12. Estimated completion is 2017-12.
What conditions does trial NCT02908880 study?
This clinical trial studies the following conditions: Femoral Arteriotomy Closure.
What interventions are being tested in trial NCT02908880?
The interventions under investigation include: MANTA vascular closure device (DEVICE).
Who is sponsoring clinical trial NCT02908880?
This trial is sponsored by Essential Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02908880 being conducted?
This trial has 19 study locations across California, District of Columbia, Illinois, Indiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02908880's enrollment target sits among peer trials
263 396th of 2000 higher than 1,604 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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