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

Inguinal Hernia Clinical Trial

— RAFDT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03526341
• Other study ID #: MDT17047RAF
• Status: Completed
• Start date: April 25, 2018
• Est. completion date: September 10, 2019

Study information

• Verified date: October 2019
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: September 10, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Hernia, Ventral
• Inguinal Hernia
• Ventral Hernia

Intervention

Device:
• ReliaTack™ Articulating Reloadable Fixation Device
ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Tacks

Locations

Country	Name	City	State
United States	Hudson Valley Surgical Group	Sleepy Hollow	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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