Clinical trials: Ventral Hernias
Ventral Hernia
Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair
A multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in subjects undergoing ventral hernia repair to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and…
- Trial name
- PPDS (NCT03495154)
- Testing
- Parietene DS Composite Mesh
- Where
- 6 sites in United States
- Volunteers
- 145 people
- Sponsor
- Medtronic - MITG
Inguinal Hernia, Ventral Hernia
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Hernia Surgery (Enable Hernia Repair)
A prospective, multicenter, single-arm pivotal study will be performed with 192 subjects enrolled to have an inguinal or ventral robotic hernia repair procedure using the Medtronic Hugo™ RAS system.
- Trial name
- NCT06445504
- Testing
- Robotic-Assisted Surgery (RAS) Hernia Repair Surgery
- Where
- 7 sites in United States
- Volunteers
- 206 people
- Sponsor
- Medtronic - MITG
Ventral Hernias
Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair
The objective this study is to collect post-market data on the performance of the Zenapro™ Hybrid Hernia Repair Device when used to reinforce or bridge the abdominal wall for the repair of ventral hernias.
- Trial name
- NCT01784822
- Testing
- Zenapro™ Hybrid Hernia Repair Device
- Where
- 5 sites in United States
- Volunteers
- 63 people
- Sponsor
- Cook Group Incorporated
Abdominal Wall Defect, Ventral Hernia
Clinical Study on the Safety of SAFIL® MESH
Observational, Retrospective, Multi-center Clinical Study on the Safety of SAFIL® MESH in Patients Undergoing Reinforcement of Soft Tissues After Abdominal Wall Surgery or Other Fascial Defects
- Conditions
- Abdominal Wall Defect, Ventral Hernia, Abdominal Hernia, Fascial Hernia
- Trial name
- SAFIL_MESH (NCT04947202)
- Testing
- Hernioplasty
- Where
- 2 sites in Spain
- Volunteers
- 152 people
- Sponsor
- Aesculap AG
Ventral Incisional Hernia
Open Complex Ventral Incisional Hernia Repair Using Biosynthetic Material for Midline Fascial Closure Reinforcement
Prospective, multicenter, observational study to evaluate performance of GORE® BIO-A® Tissue Reinforcement when used to reinforce midline fascial closure in single-staged open complex ventral incisional hernia repair.
- Trial name
- COBRA (NCT01325792)
- Testing
- GORE® BIO-A® Tissue Reinforcement
- Where
- 9 sites in United States, Netherlands
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- W.L.Gore & Associates
Hernia, Ventral
Ventral Hernia Study Using OviTex Reinforced Bioscaffold
The study is designed to demonstrate that the use of OviTex® 1S material for a ventral hernia repair leads to the same or a lower percentage of early post-operative complications and true hernia recurrences when compared to other…
- Trial name
- NCT03074474
- Testing
- OviTex 1S Permanent
- Where
- 7 sites in United States
- Volunteers
- 92 people
- Sponsor
- Tela Bio Inc
Hernia, Ventral, Hernia Incisional
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
The SYN 20-01 Study is a non-interventional, prospective, multicenter, multicohort, international, post-market clinical investigation looking into the assessment of GORE® SYNECOR Biomaterial in focused patient populations and in…
- Conditions
- Hernia, Ventral, Hernia Incisional, Hernia Incisional Ventral
- Trial name
- SYN 20-01 (NCT05094089)
- Testing
- Hernia repair with mesh
- Where
- 15 sites in United States, Italy and 2 more
- Volunteers
- 320 people
- Sponsor
- W.L.Gore & Associates
Ventral Hernia Repair
Robotic Minimally Invasive Ventral Hernia Repair With DEXTER
The aim of this clinical investigation is to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing incisional or primary ventral hernia…
- Trial name
- RAVEN (NCT07071740)
- Testing
- ventral hernia repair
- Where
- 5 sites in Austria, France and 2 more
- Volunteers
- 33 people
- Sponsor
- Distalmotion SA
Ventral Hernia, Abdominal Hernia
A Study to Evaluate Adverse Events and Effectiveness of OnabotulinumtoxinA in Participants Undergoing Open Abdominal Ventral Hernia Repair for the Achievement of Primary Fascial Closure Without the Use of Component Separation Technique
Ventral hernias form when there is a loss of integrity of the abdominal wall muscles. Abdominal hernias can expand and can cause severe pain as the abdominal wall weakens.
- Trial name
- NCT05606757
- Testing
- BOTOX Dose A, BOTOX Dose B, BOTOX Dose C
- Where
- 2 sites in United States
- Sponsor
- AbbVie
Ventral Hernia, Incisional Hernia
A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.
Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates.
- Trial name
- NCT01961687
- Testing
- Resorbable Mesh
- Where
- 16 sites in United States
- Volunteers
- 121 people
- Sponsor
- C. R. Bard
Hernia
Repair of Infected or Contaminated Hernias
This is a prospective, multicenter, interventional, observational, open label, single arm, longitudinal evaluation of ventral incisional hernia repair using LTM in contaminated or infected sites.
- Trial name
- RICH (NCT00617357)
- Testing
- LTM (Strattice Reconstructive Tissue Matrix)
- Where
- 15 sites in United States
- Volunteers
- 83 people
- Sponsor
- LifeCell
Hernia, Hernia, Ventral
T-GENVIH-003 LTFU (Long Term Follow Up) Study
The T-GENVIH-003 study will collect additional, longer term performance data of Gentrix® Surgical Matrix used for reinforcement of ventral hernia repairs from a subset population (i.e., the twenty-one minimally invasive surgical…
- Conditions
- Hernia, Hernia, Ventral, Pathological Conditions, Anatomical, Hernia, Abdominal
- Trial name
- NCT06034652
- Testing
- Integra® Gentrix® Surgical Matrix
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Integra LifeSciences Corporation
Ventral Hernia
Pain and Quality of Life After Retromuscular Ventral Hernia Repair (RECOVER)
The study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted retromuscular ventral hernia repair.
- Trial name
- RECOVER (NCT04487522)
- Testing
- Open retromuscular ventral hernia repair, Laparoscopic retromuscular ventral hernia repair, Robotic-assisted retromuscular ventral hernia repair
- Where
- 4 sites in United States
- Volunteers
- 74 people
- Sponsor
- Intuitive Surgical
Rectocele, Enterocele
A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy
The purpose of this observational study is to evaluate the clinical outcome of a modified d'Hoore technique for laparoscopic ventral mesh rectopexy in patients with primary rectal prolapse, rectocele and/or enterocele.The goal of…
- Conditions
- Rectocele, Enterocele, Rectal Prolapse
- Trial name
- POP-01 (NCT04564677)
- Testing
- Ifabond (Péters surgical)
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- Duomed
Hernia, Obesity
Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery
The primary objective is to compare the effectiveness of the Surgisis Gold Graft to suture closure alone in preventing an incisional hernia after open bariatric surgery.
- Trial name
- NCT00274625
- Testing
- Surgisis Gold Graft, Control
- Where
- 2 sites in United States
- Volunteers
- 402 people
- Sponsor
- Cook Group Incorporated
Inguinal Hernia, Ventral Hernia
Post Market Clinical Follow Up Study for ReliaTack™ Articulating Reloadable Fixation Device With Deep Purchase Tacks
A post-market clinical follow-up study for ReliaTack™ articulating reloadable fixation device with deep purchase tacks
- Trial name
- RAFDT (NCT03526341)
- Testing
- ReliaTack™ Articulating Reloadable Fixation Device
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- Medtronic - MITG
Ventral Hernia
Miromatrix Biological Mesh for Ventral Hernia Repair
This study is being conducted to gather long-term data of the performance of the Miromatrix Biological Mesh.
- Trial name
- MIROMESH PM-1 (NCT02408458)
- Testing
- MIROMESH®
- Where
- 4 sites in United States
- Sponsor
- Miromatrix Medical Inc.
Hernia
A Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation
This will be an observational study designed to collect early, short- and long-term clinical outcomes of the XenMatrix™ Surgical Graft for complex ventral hernia repair.
- Trial name
- XenMatrix (NCT01305486)
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- C. R. Bard
Ventral Hernia
AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair
Medtronic is sponsoring and funding the AFFIX study, a prospective, post-market, multicenter, nonrandomized, single-arm, interventional clinical study.
- Trial name
- AFFIX (NCT06710795)
- Testing
- MaxTack™ Motorized Fixation Device
- Where
- 3 sites in United States
- Volunteers
- 35 people
- Sponsor
- Medtronic - MITG
Ventral Hernia
Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1
The purpose of the registry is to evaluate safety and efficacy of the Intramesh T1. This registry will collect data from 100 patients treated for a ventral hernia repair.
- Trial name
- NCT01816867
- Testing
- Intramesh T1 implantation
- Where
- Belgium
- Volunteers
- 96 people
- Sponsor
- be Medical