Post Market Clinical Follow Up Study for ReliaTack™ Articulating Reloadable Fixation Device With Deep Purchase Tacks
Completed
Conditions studied: Inguinal Hernia, Ventral Hernia
In brief
A post-market clinical follow-up study for ReliaTack™ articulating reloadable fixation device with deep purchase tacks
Key facts
- Study ID
- NCT03526341
- Run by
- Medtronic - MITG
- People needed
- 116
- Starts
- 2018-04-25
- Expected to finish
- 2019-09-10
- Last updated by the study team
- 2019-10-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject underwent ventral or inguinal/femoral hernia repair procedure utilizing ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Tacks on or after 510(k) approval.
- Medical records are available, which document a ventral and/or inguinal/femoral hernia repair surgical procedure.
You may not qualify if…
- Institutional Review Board (IRB) consent requirement cannot be met:
- waiver of subject informed consent requirements are not granted by IRB* and,
- an altercation to the consent process is not granted by the IRB and,
- subject or subject's parent or legal guardian is unable or unwilling to provide signed informed consent
- Subject was participating in any investigational drug or device study at the time of surgery or within 30-day (+3 days) study window
- Subject was pregnant at the time of procedure
- Subject had a documented allergy at the time of surgery to any of the components of the device or the mesh implant
- Subject was treated with any other implantable mechanical fixation device, other than sutures
- A waiver of subject informed consent procedures will be requested from all IRBs of record for this study.
Where it is running
- Hudson Valley Surgical Group — Sleepy Hollow, New York, United States
Full record on ClinicalTrials.gov
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