Post Market Clinical Follow Up Study for ReliaTack™ Articulating Reloadable Fixation Device With Deep Purchase Tacks

Completed

• Conditions: Inguinal Hernia; Ventral Hernia

• Registration Number: NCT03526341
• Lead Sponsor: Medtronic - MITG

Brief Summary

A post-market clinical follow-up study for ReliaTack™ articulating reloadable fixation device with deep purchase tacks

Detailed Description

A retrospective, multi-center, chart review of medical records on the use of the device for two (2) surgical procedure indications:

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.

Study Timeline

• Study First Submitted: 2018-04-17
• Study Start: 2018-04-25
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-16
• Primary Completion: 2019-09-10
• Study Completion: 2019-09-10
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-08
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

1. 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.
2. Medical records are available, which document a ventral and/or inguinal/femoral hernia repair surgical procedure.

Exclusion Criteria

1. Institutional Review Board (IRB) consent requirement cannot be met:

   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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	30 days (+3 days) post procedure	Safety will be assessed as the proportion of subjects with SADE's/AEs

Secondary Outcome Measures

Name	Time	Method
The rate of device-related malfunctions will be captured to confirm the performance for this device during inguinal/ femoral and ventral hernia repair procedures	30 days (+3 days) post procedure	The rate of device-related malfunctions affecting performance of the device will be captured

Trial Locations

Locations (1)

Hudson Valley Surgical Group; 🇺🇸 Sleepy Hollow, New York, United States