Clinical trials: Abdomen Hernia
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
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
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
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
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.
Hiatal Hernia
Miromatrix Biological Mesh for Hiatal Hernia Repair
Miromatrix Medical has developed MIROMESH® - a new, noncrosslinked, acellular mesh derived from the highly vascularized porcine liver.
- Trial name
- NCT02436681
- Testing
- MIROMESH
- Where
- 6 sites in United States
- Volunteers
- 50 people
- Sponsor
- Miromatrix Medical Inc.
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
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 Hernia
Hernia Repair in Multiply Morbid Patients
Support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in a diminished rate of hernia recurrence.
- Trial name
- RAM2P (NCT00930787)
- Testing
- Strattice Reconstructive Tissue Matrix (Hernia Repair), Proceed Surgical Mesh (Hernia repair)
- Where
- 13 sites in United States
- Volunteers
- 23 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
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
Postoperative Pain
Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in…
- Trial name
- NCT03237481
- Testing
- HTX-011, Bupivacaine HCl, Luer-lock applicator
- Where
- 24 sites in United States, Belgium
- Volunteers
- 418 people
- Sponsor
- Heron Therapeutics
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
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
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
Incisional Hernia
ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention
Interventional, prospective, multicenter, post-marketing clinical follow-up study. After midline laparotomy, the probability to develop an incisional hernia ranges from 10% to 50% depending on the complexity of the surgery and…
- Trial name
- POETRY (NCT03912662)
- Testing
- Mesh augmented reinforcement
- Where
- 11 sites in France
- Volunteers
- 32 people
- Sponsor
- Medtronic - MITG
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
Inguinal Hernia
Evaluation of the Safety, Efficacy, and Pharmacokinetics of SKY0402 in Subjects Undergoing Inguinal Hernia Repair
The primary objective of this study was to determine the appropriate dose of SKY0402 for the management of postoperative pain following inguinal hernia repair.
- Trial name
- NCT01203644
- Testing
- SKY0402, Bupivacaine HCl
- Volunteers
- 76 people
- Sponsor
- Pacira Pharmaceuticals, Inc
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
Inguinal Hernia
Inguinal Hernia Study Using Biodesign IHM
Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective…
- Trial name
- NCT00393887
- Testing
- Biodesign IHM, Polypropylene mesh
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Cook Group Incorporated