Clinical trials: Hernia Repair
Postoperative Complications
TAPP Inguinal Hernia Repair With Self-fixating Parietex™ ProGrip™ Mesh
The objective of this retrospective study is to evaluate the postoperative clinical outcomes at discharge, 1 month and 12 months, associated with the use of Parietex™ ProGrip™ in Laparoscopic Transabdominal preperitoneal inguinal…
- Trial name
- NCT01481376
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Medtronic - MITG
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
Pain, Postoperative
Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty
This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled efficacy and safety study of postoperative pain in adults who are scheduled for unilateral inguinal hernioplasty via open laparotomy…
- Trial name
- MATRIX-2 (NCT02525133)
- Testing
- XaraColl
- Where
- 24 sites in United States
- Volunteers
- 319 people
- Sponsor
- Innocoll
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
Inguinal Herniorrhaphy
A Phase 2, Randomized, Double-Blind, Dose Escalation Study in Postoperative Pain Open Inguinal Herniorrhaphy
This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing open inguinal herniorrhaphy with mesh.
- Trial name
- NCT05080959
- Testing
- CPL-01, Naropin 150 MG Per 20 ML Injection
- Where
- 5 sites in United States
- Volunteers
- 105 people
- Sponsor
- Cali Pharmaceuticals LLC
Hernioplasty
Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant
Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy hernioplasty and assess the relative bioavailability of Xaracoll compared to a local bupivacaine infiltration.
- Trial name
- NCT02232178
- Testing
- 2 100mg Xaracoll implants, 3 100mg Xaracoll implants, 150mg Bupivacaine HCl injection
- Where
- 5 sites in United States
- Volunteers
- 64 people
- Sponsor
- Innocoll
Inguinal Hernia
A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair
This investigation will be a double-armed, randomized (Blinded patients and Blinded examiner) prospective study designed to collect perioperative and postoperative data to compare the QOL of ProFlor vs.
- Trial name
- NCT02240550
- Testing
- ProFlor Hernia Repair System, Lichtenstein hernia repair
- Where
- India
- Volunteers
- 50 people
- Sponsor
- Insightra Medical, Inc.
Hernia, Inguinal
Safety and Performance of the OTTAVA System in Participants Undergoing Inguinal Hernia Repair
The purpose of this study is to assess safety and performance of the OTTAVA System, through 30 days postoperative, in participants undergoing robotic-assisted inguinal hernia repair (IHR).
- Trial name
- TEMPO (NCT07298317)
- Testing
- OTTAVA Robotic System
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Auris Health, Inc.
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
Postoperative Pain
Dose-ranging Study for Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair
The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of bupivacaine HCl.
- Trial name
- NCT00485433
- Testing
- Bupivacaine HCl, SKY0402
- Where
- 7 sites in United States
- Volunteers
- 98 people
- Sponsor
- Pacira Pharmaceuticals, Inc
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
Pain, Postoperative, Hernia, Inguinal
Surgical Pain After Inguinal Hernia Repair (SPAIHR)
The purpose of this study is to test whether pregabalin added to the standard of care with dosing starting preoperatively and continuing for 1 week post surgery will decrease the intensity of acute post-operative pain following…
- Trial name
- NCT00551135
- Testing
- Pregabalin
- Where
- 42 sites in United States, Australia and 4 more
- Volunteers
- 425 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hernia, Inguinal, Hernia, Inguinal, Direct
Evaluation of Clinical Outcomes in Robotic-Assisted Inguinal Hernia Repair
This multi-center, retrospective data collection study will evaluate the feasibility, safety and performance of the da Vinci® surgical system for patients who have undergone robotic-assisted inguinal hernia repair, as well as…
- Conditions
- Hernia, Inguinal, Hernia, Inguinal, Direct, Hernia, Inguinal, Indirect
- Trial name
- NCT02684448
- Testing
- Inguinal Hernia Repair
- Where
- 2 sites in United States
- Volunteers
- 1,258 people
- Sponsor
- Intuitive Surgical
Mucopolysaccharidosis (MPS)
Mucopolysaccharidosis (MPS) I, II, and VI Screening in a High-Risk Population With Previous Surgical Repair or Presence of Inguinal and/or Umbilical Hernia in Combination With Pediatric ENT Surgery (The HATT Project)
Mucopolysaccharidosis (MPS) type II (MPS II; Hunter syndrome) is a rare, X-linked disease caused by a deficiency of the lysosomal enzyme iduronate-2-sulfatase (I2S) and occurs almost exclusively in boys, with an incidence of…
- Trial name
- NCT02095015
- Where
- 14 sites in United States, Canada and 5 more
- Volunteers
- 159 people
- Sponsor
- Shire
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
Inguinal Hernia
Pain and Quality of Life After Inguinal Hernia Repair
This study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted inguinal hernia repair.
- Trial name
- PREPARE (NCT04074200)
- Testing
- Open Inguinal Hernia Repair, Laparoscopic Inguinal Hernia Repair, Robotic-Assisted Inguinal Hernia Repair
- Where
- United States
- Volunteers
- 156 people
- Sponsor
- Intuitive Surgical
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
Incisional Hernia Repair
Comparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair
Optilene® Mesh Elastic and Ultrapro® Mesh will be used for incisional hernia repair. The primary objective of this clinical study is to demonstrate that Optilene® Mesh Elastic is superior to Ultrapro® Mesh in incisional hernia…
- Trial name
- Optilene (NCT00646334)
- Testing
- Mesh Implantation
- Where
- 6 sites in Germany
- Volunteers
- 80 people
- Sponsor
- Aesculap AG
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, 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