An observational study in Inguinal Hernia and Ventral Hernia, sponsored by Medtronic - MITG. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-09.
Sponsored by Medtronic - MITG · Observational
A post-market clinical follow-up study for ReliaTack™ articulating reloadable fixation device with deep purchase tacks
A retrospective, multi-center, chart review of medical records on the use of the device for two (2) surgical procedure indications:
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.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 116 is close to the median of 120 across 327 observational studies indexed under Hernia.
Browse Hernia studies →Medtronic - MITG is the lead sponsor of 176 studies on the registry; 5 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects who previously underwent minimally invasive or open surgical ventral or inguinal/femoral hernia repair procedures using the ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Tacks.
Exclusion Criteria:
Institutional Review Board (IRB) consent requirement cannot be met:
Subject was treated with any other implantable mechanical fixation device, other than sutures
ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Tacks
To confirm the safety for this device during inguinal/ femoral and ventral hernia repair procedures by assessing the proportion of subjects with SADE's/AEs
Safety will be assessed as the proportion of subjects with SADE's/AEs
Time frame: 30 days (+3 days) post procedure
The rate of device-related malfunctions will be captured to confirm the performance for this device during inguinal/ femoral and ventral hernia repair procedures
The rate of device-related malfunctions affecting performance of the device will be captured
Time frame: 30 days (+3 days) post procedure
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Medtronic - MITG