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

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

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia; Ventral Hernia
• Intervention / Treatment: Device: ReliaTack™ Articulating Reloadable Fixation Device

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 Type: Observational
• Enrollment (Actual): 116

Contacts and Locations

Study Locations

• United States
  • New York
    • Sleepy Hollow, New York, United States, 10591
      • Hudson Valley Surgical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days (+3 days) post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days (+3 days) post procedure

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: John W Odom, MD, St. Josephs/ Candler; Principal Investigator: Har Chi Lau, MD, Hudson Valley Surgical Group

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 25, 2018
• Primary Completion (ACTUAL): September 10, 2019
• Study Completion (ACTUAL): September 10, 2019

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (ACTUAL): May 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 9, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Hernia, Ventral
• Other Study ID Numbers: MDT17047RAF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes