Clinical trials: Hernioplasty
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.
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 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 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
Hiatal Hernia With Gastroesophageal Reflux Disease, Gastroesophageal Reflux
Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH
Investigator will identify a consecutive cohort of patients who have undergone a hiatal hernia repair and are at least 6 months post index procedure.
- Conditions
- Hiatal Hernia With Gastroesophageal Reflux Disease, Gastroesophageal Reflux, GERD
- Trial name
- NCT03735862
- Testing
- Hepatic derived surgical matrix
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Miromatrix Medical Inc.
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
Postoperative Pain
Pilot Herniorrhaphy Study for Postoperative Analgesia
A Phase 2, Randomized, Pilot Study to Investigate the Safety, Efficacy, Pharmacokinetics and Bioavailability of HTX-011, HTX-002, or HTX-009 Administered Via Injection and/or Topical Application Following Unilateral Open Inguinal…
- Trial name
- NCT02504580
- Testing
- HTX-011, HTX-002, Bupivacaine HCI (Marcaine)
- Where
- 3 sites in United States
- Volunteers
- 463 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
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
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.
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 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
Postoperative Pain, Hernia
A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair
This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local…
- Conditions
- Postoperative Pain, Hernia, Surgery
- Trial name
- NCT00974350
- Testing
- SABER-Bupivacaine
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 124 people
- Sponsor
- Durect
Hernia
A Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite
This study will enroll subjects who underwent a laparoscopic ventral hernia repair utilizing Sepramesh at least 12 months before starting in this study.
- Trial name
- Sepramesh (NCT01305473)
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- C. R. Bard
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