Post Market Clinical Follow Up Study for ReliaTack™ Articulating Reloadable Fixation Device With Deep Purchase Tacks
NCT ID: NCT03526341
Last Updated: 2019-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
116 participants
OBSERVATIONAL
2018-04-25
2019-09-10
Brief Summary
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Detailed Description
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1. inguinal/femoral hernia
2. ventral hernia
A minimum of 4 sites in the United States will perform chart review and enter 116 study records in the database for data collection. The 116 subject records will be comprised of 76 for the inguinal/femoral indication, and 40 for the ventral indication.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Interventions
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ReliaTack™ Articulating Reloadable Fixation Device
ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Tacks
Eligibility Criteria
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Inclusion Criteria
2. Medical records are available, which document a ventral and/or inguinal/femoral hernia repair surgical procedure.
Exclusion Criteria
1. waiver of subject informed consent requirements are not granted by IRB\* and,
2. an altercation to the consent process is not granted by the IRB and,
3. subject or subject's parent or legal guardian is unable or unwilling to provide signed informed consent
2. Subject was participating in any investigational drug or device study at the time of surgery or within 30-day (+3 days) study window
3. Subject was pregnant at the time of procedure
4. Subject had a documented allergy at the time of surgery to any of the components of the device or the mesh implant
5. 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.
18 Years
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
Responsible Party
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Principal Investigators
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John W Odom, MD
Role: PRINCIPAL_INVESTIGATOR
St. Josephs/ Candler
Har Chi Lau, MD
Role: PRINCIPAL_INVESTIGATOR
Hudson Valley Surgical Group
Locations
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Hudson Valley Surgical Group
Sleepy Hollow, New York, United States
Countries
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Other Identifiers
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MDT17047RAF
Identifier Type: -
Identifier Source: org_study_id
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