Inguinal Hernia Clinical Trial
— RAFDTOfficial title:
Post Market Clinical Follow Up Study for ReliaTack™ Articulating Reloadable Fixation Device With Deep Purchase Tacks
Verified date | October 2019 |
Source | Medtronic - MITG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A post-market clinical follow-up study for ReliaTack™ articulating reloadable fixation device with deep purchase tacks
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. |
Country | Name | City | State |
---|---|---|---|
United States | Hudson Valley Surgical Group | Sleepy Hollow | New York |
Lead Sponsor | Collaborator |
---|---|
Medtronic - MITG |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03023462 -
Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair
|
N/A | |
Completed |
NCT04272320 -
The Efficacy of Transversalis Fascia Plane Block in Pediatric Inguinal Hernia Repair
|
N/A | |
Recruiting |
NCT03904888 -
Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair
|
N/A | |
Recruiting |
NCT03856710 -
Self Fixating Versus Stapled Mesh for Laparoscopic Inguinal Hernia Repair
|
N/A | |
Completed |
NCT02240550 -
A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair
|
N/A | |
Completed |
NCT01679353 -
Comparison of Analgesic Effect of Magnesium Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia on Postoperative Pain Control in Pediatric Patients Undergoing Inguinal Hernia Repair
|
N/A | |
Completed |
NCT01943760 -
Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty
|
Phase 4 | |
Recruiting |
NCT01450345 -
Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain
|
Phase 3 | |
Active, not recruiting |
NCT00968773 -
Rebound Hernia Repair Device Mesh Trial
|
Phase 4 | |
Completed |
NCT01000116 -
Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP)
|
N/A | |
Completed |
NCT01117337 -
Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Inguinal Hernia Repair
|
Phase 4 | |
Terminated |
NCT00226161 -
Chronic Pain After Inguinal Herniorrhaphy
|
N/A | |
Completed |
NCT05837013 -
Open and Laparoscopic Total Extraperitoneal Repair Under Spinal Anesthesia Versus General Anesthesia
|
N/A | |
Recruiting |
NCT05058378 -
Correlation Between Spinal Anesthesia and Perfusion Index
|
||
Completed |
NCT01637818 -
Long-term Follow-up of Lichtenstein's Operation Versus Mesh Plug Repair
|
N/A | |
Recruiting |
NCT05879770 -
Is the Use of Prolene as Sufficient as the Use of Wire in Shouldice Surgery to Keep the Recurrence Rate Low After One Year?
|
||
Completed |
NCT05159232 -
Length of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial
|
N/A | |
Completed |
NCT05107986 -
Laparoscopy in Complicated Groin Hernia
|
||
Active, not recruiting |
NCT04328597 -
Portuguese Inguinal Hernia Cohort (PINE) Study
|
||
Completed |
NCT04033055 -
Antalgic Efficacy of CycloMesh™ Soaked in Ropivacaine Hydrochloride in Uncomplicated Inguinal Hernia.
|
N/A |