Inguinal HerniaRAFDTNCT03526341
Post Market Clinical Follow Up Study for ReliaTack™ Articulating Reloadable Fixation Device With Deep Purchase Tacks
An observational study of Inguinal Hernia and Ventral Hernia, run by Medtronic - MITG at 1 site in United States.
Trial summary
A post-market clinical follow-up study for ReliaTack™ articulating reloadable fixation device with deep purchase tacks Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia, Ventral Hernia
- What is being tested?
- ReliaTack™ Articulating Reloadable Fixation Device
- Type of treatment
- Medical device
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2018to 10 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hudson Valley Surgical Group
Sleepy Hollow, New York, 10591
About this study
A post-market clinical follow-up study for ReliaTack™ articulating reloadable fixation device with deep purchase tacks
Read the detailed description
A retrospective, multi-center, chart review of medical records on the use of the device for two (2) surgical procedure indications:
- inguinal/femoral hernia
- 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.
- Conditions
- Inguinal Hernia, Ventral Hernia
- Being tested
- ReliaTack™ Articulating Reloadable Fixation Device
- Medical subject headings
- Hernia, Inguinal, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReliaTack™ Articulating Reloadable Fixation DeviceDevice
ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Tacks
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
The rate of device-related malfunctions affecting performance of the device will be captured
Measured: 30 days (+3 days) post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start25 Apr 2018
- Primary completion10 Sep 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John W Odom, MD, Principal investigator, St. Josephs/ CandlerHar Chi Lau, MD, Principal investigator, Hudson Valley Surgical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526341
- Sponsor's protocol ID
- MDT17047RAF
- Acronym
- RAFDT
- Status last verified
- Oct 2019
- First submitted
- 17 Apr 2018
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow Up Study for ReliaTack™ Articulating Reloadable Fixation Device With Deep Purchase Tacks
- ClinicalTrials.gov ID
- NCT03526341
- Acronym / sponsor ID
- RAFDT / MDT17047RAF
- Conditions
- Inguinal Hernia, Ventral Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 16 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- inguinal/femoral hernia
- 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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- Institutional Review Board (IRB) consent requirement cannot be met:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReliaTack™ Articulating Reloadable Fixation DeviceReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Tacks | Device | – |
Primary outcome
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
Time frame: 30 days (+3 days) post procedure
Safety will be assessed as the proportion of subjects with SADE's/AEs
1 secondary outcome
The rate of device-related malfunctions will be captured to confirm the performance for this device during inguinal/ femoral and ventral hernia repair procedures
Time frame: 30 days (+3 days) post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W Odom, MD principal investigator
St. Josephs/ Candler
Har Chi Lau, MD principal investigator
Hudson Valley Surgical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia and Ventral Hernia, run by Medtronic - MITG at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 30 days (+3 days) post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.