Clinical trials: Ventral Hernia Repair
Hernia
AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE
The primary purpose of this clinical trial is to assess the safety and performance of the ECLIPSIUM device in securing mesh during ventral hernia repair.
- Trial name
- UNITE (NCT07277946)
- Testing
- ECLIPSIUM® System, Resorbable tacks (AbsorbaTack/SorbaFix)
- Where
- 12 sites in United States
- Volunteers
- 240 people
- Sponsor
- Tissium
Hernia
A Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft
This study will enroll subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past.
- Trial name
- AlloMax (NCT01205399)
- Where
- 5 sites in United States
- Volunteers
- 78 people
- Sponsor
- C. R. Bard
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
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
Inguinal and Ventral Hernia Repair by Sublay, Underlay and IPOM Mesh Fixation
Effectiveness, Appropriateness and Safety of GLUTACK-Glubran Tiss 2 Surgical Glue Compared to GLUTACK-Glubran 2 Device System for Mesh Fastening in Laparoscopic and Robotic Hernia Surgery
This pre-market, prospective, randomized, non-inferiority clinical study was designed to evaluate the safety and performance/effectiveness of Glutack-Glubran® Tiss 2 system compared to Glutack-Glubran® used for mesh fixation in…
- Trial name
- AGluTHeMFix (NCT06462066)
- Testing
- Experimental medical device, Comparator medical device
- Where
- Italy
- Volunteers
- 101 people
- Sponsor
- GEM SRL
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
Ventral Hernia, Incisional Hernia
A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair
Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.
- Trial name
- NCT02053168
- Testing
- Resorbable Mesh
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- C. R. Bard
Ventral Hernia
Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants Undergoing Open Abdominal Ventral Hernia Repair
A ventral hernia happens when the muscles in the front of your belly become weak and let organs push through, causing a bulge. If it gets worse, intestines can slip into the bulge, leading to serious pain and health problems.
- Trial name
- NCT07226791
- Testing
- AGN-151607-DP
- Where
- 13 sites in United States
- Volunteers
- 200 people
- Sponsor
- AbbVie
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 Hernias, Incisional Hernias
Antimicrobial Hernia Repair Device
This prospective early feasibility clinical study will collect information regarding the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device to reinforce soft tissue during ventral or incisional hernia repair in…
- Trial name
- NCT02730936
- Testing
- Antimicrobial Hernia Repair Device
- Sponsor
- Cook Group Incorporated
Ventral Hernia
Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair
The purpose of this study is to collect additional safety data and demonstrate the performance of Integra Gentrix® Surgical Matrix for reinforcement of ventral hernia repairs.
- Trial name
- NCT05610267
- Testing
- Retrospective chart review
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Integra LifeSciences Corporation
Hernia, Inguinal, Hernia, Ventral
AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair
The objective of this study is to assess pain that occurs following hernia repair that is related to mesh fixation. The study is designed to see if there is any difference in pain after surgery between absorbable and permanent…
- Trial name
- NCT00749268
- Testing
- AbsorbaTack, ProTack
- Where
- 2 sites in United States
- Volunteers
- 216 people
- Sponsor
- Medtronic - MITG
Ventral Hernia
A Comparison of Fortiva and Strattice Tissue Matrices in Complex, Ventral Hernia Repair
The objective of this study is to compare the effectiveness of Fortiva Porcine Dermis versus Strattice Reconstructive Tissue Matrix for the underlay reinforcement of complex ventral hernia repair and assess post-operative…
- Trial name
- NCT02587403
- Testing
- Fortiva™ Porcine Dermis, Strattice™ Reconstructive Tissue Matrix
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- RTI Surgical
Hernia
Assuring and Defining Outcomes Through Procedural Training Using a Proctorship Model That Collects Patient Outcomes A Single-Arm, Case-Series to Determine the Feasibility of Safe Skills Transfer for Laparoscopic Ventral Hernia Repair Utilizing a Hands-On Proctorship Model.
The objective of the Project ADOPT- Ventral Hernia case-series is to collect clinical outcome data following the completion of a hands-on proctorship training model in laparoscopic ventral hernia repair.
- Trial name
- ADOPT (NCT02238743)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Medtronic - MITG
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
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
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
Ileus
A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair
This study will evaluate the safety and efficacy of two different dose regimens (12 milligrams [mg] and 24 mg) of IV MOA-728 versus placebo in shortening the time to return of bowel function in participants receiving opioid…
- Trial name
- NCT00528970
- Testing
- MOA-728
- Where
- 106 sites in United States, Australia and 9 more
- Volunteers
- 374 people
- Sponsor
- Bausch Health Americas, Inc.
Ventral Hernia Repair
SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia Repair
Prospective, multi center, single arm, clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support in ventral hernia repair.
- Trial name
- NCT01981044
- Testing
- Silk surgical mesh
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Sofregen Medical, Inc.
Ventral Hernia, Incisional Hernia
A Prospective Study of Fortiva in Hernia Repair
The goal of this study is to evaluate safety and performance of the Fortiva Tissue Matrix. Participants will complete questionnaires to measure outcomes after hernia surgery for two years.
- Conditions
- Ventral Hernia, Incisional Hernia, Abdominal Wall Reconstruction
- Trial name
- NCT06101979
- Testing
- Fortiva Tissue Matrix
- Where
- United Kingdom
- Volunteers
- 120 people
- Sponsor
- RTI Surgical