Clinical trials: Hernia, Incisional
Open Midline Laparotomy
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for…
- Trial name
- PREVENT (NCT03911700)
- Testing
- Phasix™ Mesh
- Where
- 32 sites in United States, Austria and 3 more
- Volunteers
- 477 people
- Sponsor
- C. R. Bard
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
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
Hernia Incisional Ventral
LIQUIBAND FIX8® for Ventral Incisional Hernia
This study is designed to evaluate the safety and performance of device LiquiBand FIX8 Open hernia mesh fixation device. The use of this device is not experimental, as it is already approved for use in the EU (CE-marked).
- Trial name
- LBF8-03 (NCT07295379)
- Testing
- LIQUIBAND FIX8
- Where
- United Kingdom
- Volunteers
- 148 people
- Sponsor
- Advanced Medical Solutions Ltd.
Hernia, Ventral, Incisional Hernia
A Prospective Trial of a Bio-absorbable Mesh in Challenging Laparoscopic Ventral or Incisional Hernia Repair
The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ ST in subjects receiving laparoscopic ventral or incisional hernia repair at high risk for surgical site occurrence…
- Trial name
- ATLAS (NCT02712398)
- Testing
- Phasix™ ST
- Where
- 16 sites in United States
- Volunteers
- 120 people
- Sponsor
- C. R. Bard
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
Hernia, Hernia, Abdominal
Study of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair
The purpose of this study is to collect additional data on safety and performance of Phasix™ Mesh in subjects requiring Ventral Hernia Working Group (VHWG) Grade 3 midline hernia repair.
- Conditions
- Hernia, Hernia, Abdominal, Hernia, Incisional
- Trial name
- NCT02720042
- Testing
- Phasix™ Mesh
- Where
- 15 sites in Austria, Belgium and 6 more
- Volunteers
- 84 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, 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
Hernia, Ventral, Hernia, Hiatal
GORE® ENFORM Biomaterial Product Study
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair).
- Conditions
- Hernia, Ventral, Hernia, Hiatal, Hernia, Diaphragmatic, Incisional Hernia
- Trial name
- ENF 18-06 (NCT04718168)
- Testing
- Gore ENFORM Biomaterial (Preperitoneal), Gore ENFORM Biomaterial (Intraperitoneal)
- Where
- 9 sites in United States
- Volunteers
- 245 people
- Sponsor
- W.L.Gore & Associates
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
Laparotomy, Suture; Complications, Mechanical
DuraMesh Laparotomy Study
This is a multisite randomized control proof-of-concept trial to evaluate the safety of Duramesh laparotomy closure in the trauma and emergency laparotomy setting.
- Conditions
- Laparotomy, Suture; Complications, Mechanical, Hernia Incisional
- Trial name
- NCT03966768
- Testing
- Duramesh suturable mesh for laparotomy closure, Conventional suture for laparotomy closure
- Sponsor
- Mesh Suture Inc.
Ventral Incisional Hernia
The SymCHro - Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair
The aim of this Observational Registry Study is to assess the short- and long-term clinical outcomes following the use of Symbotex™ Composite Mesh in primary and incisional abdominal wall hernia surgeries by open or laparoscopic…
- Trial name
- SymCHro (NCT02206828)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Medtronic - MITG
Surgical Incision
The REBUILD Trial: Closure of the Abdominal Wall
The main objective of this clinical trial is to demonstrate the safety and efficacy of REBUILD when used to support abdominal wall closure after laparotomy.
- Trial name
- NCT05687942
- Testing
- REBUILD
- Where
- Israel
- Volunteers
- 40 people
- Sponsor
- AbSolutions Med Inc.
Ventral Hernia, Incisional Hernia
Antimicrobial Hernia Repair Device Clinical Study
This prospective clinical study will evaluate the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in…
- Trial name
- AMEX (NCT02401334)
- Testing
- Cook® Antimicrobial Hernia Repair Device
- Where
- 4 sites in Canada, United Kingdom
- Volunteers
- 24 people
- Sponsor
- Cook Group Incorporated
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
Incisional Hernia, Incisional Hernia of Midline of Abdomen
Mesh Augmented Reinforcement of Abdominal Wall Suture Line to Limit the Rate of Incisional Hernia Occurrence
The purpose of this prospective, pivotal, multi-center, single-arm, pre-market, investigational clinical study is to assess the safety and performance of Deternia™ Self-Gripping Resorbable Mesh when used for suture line…
- Conditions
- Incisional Hernia, Incisional Hernia of Midline of Abdomen, Midline Laparotomy
- Trial name
- MARS (NCT05424484)
- Testing
- Self-Gripping Resorbable Mesh
- Where
- 13 sites in Croatia, Germany and 3 more
- Volunteers
- 123 people
- Sponsor
- Medtronic - MITG
Herniorrhaphy, Abdominoplasty
The Management of Closed Surgical Incisions Resulting From Incisional Hernia Repair and/or Functional Panniculectomy Using the Prevena™ Customizable™ Dressing
The goal of this study is to evaluate the impact of Customizable in the management of extensive closed surgical incisions for Subjects undergoing abdominal surgery for incisional hernia repair and/or functional panniculectomy as…
- Trial name
- NCT02302222
- Testing
- Customizable Dressing with ActiV.A.C. Therapy Unit, Standard of Care Dressing
- Where
- 2 sites in United States
- Volunteers
- 71 people
- Sponsor
- KCI USA, Inc
Incisional Hernia After Midline Laparotomy, Colorectal Cancer
A One-year Follow-up of Incisional Hernia Formation Between Device Assisted and Manual Laparotomy Closure
The study compares one-year incisional hernia formation between two cohorts of patients that underwent open surgery for colorectal diseases.
- Trial name
- NCT07766044
- Testing
- Device assisted laparotomy closure, Manual laparotomy closure
- Where
- Sweden
- Volunteers
- 218 people
- Sponsor
- Suturion AB
Injury of Abdominal Wall
Effect of Stitch Technique on the Occurrence of Incisional Hernia After Abdominal Wall Closure
The major long term complication of abdominal wall closure after a median laparotomy is the development of an incisional hernia.
- Trial name
- ESTOIH (NCT01965249)
- Testing
- Long stitch, Short Stitch
- Where
- 9 sites in Austria, Germany
- Volunteers
- 425 people
- Sponsor
- Aesculap AG