Clinical trial NCT03526341: Post Market Clinical Follow Up Study for ReliaTack™ Articulating Reloadable Fixation Device With Deep Purchase Tacks
Official title: Post Market Clinical Follow Up Study for ReliaTack™ Articulating Reloadable Fixation Device With Deep Purchase Tacks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Ventral Hernia
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2018-05-16
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 30 days (+3 days) post procedure
Secondary outcomes:
measure: The rate of device-related malfunctions will be captured to confirm the performance for this device during inguinal/ femoral and ventral hernia repair procedures
timeFrame: 30 days (+3 days) post procedure
Other outcomes:
Locations:
city: Sleepy Hollow
country: United States
facility: Hudson Valley Surgical Group
state: New York
Study officials:
affiliation: St. Josephs/ Candler
name: John W Odom, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hudson Valley Surgical Group
name: Har Chi Lau, MD
role: PRINCIPAL_INVESTIGATOR
References: