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

NCT03526341 | Completed DMC FDA Device

• 1 other identifier: MDT17047RAF
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inguinal Hernia; Ventral Hernia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

ReliaTack™ Articulating Reloadable Fixation Device DEVICE

ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Tacks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Hudson Valley Surgical Group

Sleepy Hollow, New York, 10591, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal; Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• John W Odom, MD

  St. Josephs/ Candler

  PRINCIPAL INVESTIGATOR

• Har Chi Lau, MD

  Hudson Valley Surgical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 16, 2018
• Study Start: April 25, 2018
• Primary Completion: September 10, 2019
• Study Completion: September 10, 2019
• Last Updated: October 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)