Clinical trials: Abdominal Hernia
Postoperative Pain, Inguinal Hernia
Efficacy, Safety and Pharmacokinetic Profile of a Collagen Bupivacaine Implant in Men After Open Mesh Herniorrhaphy
The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after herniorrhaphy.
- Trial name
- NCT00626886
- Testing
- Bupivacaine Collagen Sponge
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Innocoll
Postoperative Pain
Phase 2 Herniorrhaphy Study for Opioid Elimination
This is a Phase 2, open-label study in subjects undergoing unilateral open inguinal herniorrhaphy.
- Trial name
- NCT03695367
- Testing
- HTX-011, Luer lock applicator, Vial access device
- Where
- 5 sites in United States
- Volunteers
- 63 people
- Sponsor
- Heron Therapeutics
Hernia, Inguinal Hernia
A Clinical Study to Evaluate the Clinical Performance and Safety of LiquiBand FIX8® Versus AbsorbaTack™ for Hernia Mesh Fixation and Peritoneal Closure in Groin Hernia Repair
This is a multi-center, randomized controlled trial of 284 subjects (142 in each group). Patients will be blinded to the fixation method used.
- Conditions
- Hernia, Inguinal Hernia, Femoral Hernia, Groin Hernia
- Trial name
- NCT04009213
- Testing
- LiquiBand FIX8®, AbsorbaTack™
- Where
- 6 sites in United States
- Volunteers
- 284 people
- Sponsor
- Advanced Medical Solutions Ltd.
Bariatric Surgery Candidate, Hiatal Hernia
Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device
The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the…
- Trial name
- NCT06432088
- Testing
- Extended Magnetic Grasper Device
- Where
- Chile
- Volunteers
- 30 people
- Sponsor
- Levita Magnetics
Inguinal Hernia
Phase I/II Dose-escalation Study to Evaluate Safety, PK and Efficacy of TLC590 for Postsurgical Pain Management
Phase I/II, randomized, double-blind, comparator-controlled, dose-escalation study to assess the safety, PK, and efficacy of single postsurgical application of TLC590 compared with Naropin®
- Trial name
- NCT03591146
- Testing
- TLC590, Naropin
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Taiwan Liposome Company
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, 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
Hernia
EXPAREL Infiltrated Into the TAP for Postoperative Analgesia in Unilateral Abdominal Hernia Repair
Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the Transversus Abdominis Plane (TAP).
- Trial name
- 702 (NCT01801124)
- Testing
- EXPAREL
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Pacira Pharmaceuticals, Inc
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, Inguinal
Parietex Progrip Study
The objective of the study is to evaluate pain and disabling complications inducing social consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair with lightweight polypropylene mesh.
- Trial name
- NCT00827944
- Testing
- Parietex Progrip, Low weight polypropylene mesh
- Where
- 9 sites in Belgium, Germany and 3 more
- Volunteers
- 603 people
- Sponsor
- Medtronic - MITG
Ventral Hernia
Post-market Study of the Biodesign Hernia Graft
The purpose of this study is to collect data on the performance of the Biodesign® Hernia Graft when used to reinforce soft tissues during ventral hernia repair.
- Trial name
- NCT04294446
- Testing
- Biodesign Hernia Graft
- Where
- 3 sites in United States, Canada
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Cook Biotech Incorporated
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
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
Herniorrhaphy, Postoperative Pain
Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy
This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen…
- Conditions
- Herniorrhaphy, Postoperative Pain, Inguinal Hernia
- Trial name
- NCT01220024
- Testing
- Bupivacaine Collagen Sponge
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Innocoll
Parastomal Hernia
Parastomal Reinforcement With Strattice
The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of…
- Trial name
- PriSm (NCT00771407)
- Testing
- Strattice Reconstructive Matrix, Standard ostomy creation
- Where
- 23 sites in United States
- Volunteers
- 120 people
- Sponsor
- LifeCell
Analgesia
Study of Post-Herniorrhaphy Non-opioid MMA Regimens
This is a Phase 3b, open-label study to assess postoperative opioid use in subjects undergoing unilateral open inguinal herniorrhaphy with intraoperative administration of HTX-011 and a postoperative non-opioid multimodal…
- Trial name
- NCT03907176
- Testing
- HTX-011, Luer lock applicator, Ibuprofen
- Where
- 30 sites in United States
- Volunteers
- 209 people
- Sponsor
- Heron Therapeutics
Hernia
Feasibility of Permacol Use in Infected Fields
This pilot study is to examine the feasibility of using Permacol Surgical Implant in the repair of abdominal wall defects after removal of infected prosthetic mesh
- Trial name
- NCT00820040
- Testing
- acellular porcine dermal collagen mesh
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Medtronic - MITG