Clinical trials: Internal Hernia
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
Hernia, Inguinal
Comparative Study of Safety and Efficacy of Heavyweight and Partially Absorbable Mesh in Inguinal Hernia Repair
Proflex® Mesh (partially absorbable mesh, Korea) and Marlex® Mesh (heavyweight mesh) will be used for inguinal hernia repair to compare the safety and efficacy (pain score, quality of life)of two devices at 3 months follow-up.
- Trial name
- NCT01877122
- Testing
- Proflex® Mesh Mesh implantation, Marlex® Mesh Implant
- Where
- South Korea
- Volunteers
- 50 people
- Sponsor
- Samyang Biopharmaceuticals Corporation
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
Ventral Hernia
AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair
Medtronic is sponsoring and funding the AFFIX study, a prospective, post-market, multicenter, nonrandomized, single-arm, interventional clinical study.
- Trial name
- AFFIX (NCT06710795)
- Testing
- MaxTack™ Motorized Fixation Device
- Where
- 3 sites in United States
- Volunteers
- 35 people
- Sponsor
- Medtronic - MITG
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, Inguinal
Strattice in Repair of Inguinal Hernias
This is a prospective, randomized, controlled, third-party blinded, multicenter, interventional evaluation of inguinal hernia repair comparing Strattice to light weight polypropylene mesh.
- Trial name
- RING (NCT00681291)
- Testing
- Inguinal hernia repair with Ultrapro, Inguinal hernia repair with Strattice
- Where
- 8 sites in United States
- Volunteers
- 172 people
- Sponsor
- LifeCell
Gastroesophageal Reflux Disease, Hiatal Hernia
Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)
The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States.
- Trial name
- NCT01118585
- Testing
- TIF Procedure
- Where
- 14 sites in United States
- Volunteers
- 278 people
- Sponsor
- EndoGastric Solutions
Ventral Hernias
Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair
The objective this study is to collect post-market data on the performance of the Zenapro™ Hybrid Hernia Repair Device when used to reinforce or bridge the abdominal wall for the repair of ventral hernias.
- Trial name
- NCT01784822
- Testing
- Zenapro™ Hybrid Hernia Repair Device
- Where
- 5 sites in United States
- Volunteers
- 63 people
- Sponsor
- Cook Group Incorporated
Hernia
Veritas in Non-Bridging Ventral Hernia Repair
The main study objective is to determine the frequency of hernia recurrence following use of Veritas Collagen Matrix.
- Trial name
- VIBE (NCT01426477)
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- Baxter Healthcare Corporation
Inguinal Hernia
PMCF Study of LiquiBand FIX8® OHMF Device
Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.
- Trial name
- LBF8-Open (NCT04059640)
- Testing
- LiquiBand FIX8 Open Hernia Mesh Fixation Device
- Where
- 3 sites in United Kingdom
- Volunteers
- 109 people
- Sponsor
- Advanced Medical Solutions Ltd.
Hernia, Inguinal, Hernia, Ventral
AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair
The objective of this study is to assess pain that occurs following hernia repair that is related to mesh fixation. The study is designed to see if there is any difference in pain after surgery between absorbable and permanent…
- Trial name
- NCT00749268
- Testing
- AbsorbaTack, ProTack
- Where
- 2 sites in United States
- Volunteers
- 216 people
- Sponsor
- Medtronic - MITG
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
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, 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
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
Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®
This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.
- Trial name
- ECH2O2 (NCT07070115)
- Testing
- OviTex Reinforced Tissue Matrix
- Where
- 5 sites in United States
- Volunteers
- 173 people
- Sponsor
- Tela Bio Inc
Inguinal Hernia
Clinical Performance of HISTOACRYL® LAPFIX - CANNULA for Laparoscopic Inguinal Hernia Repair
The goal of this retrospective study is to identify the incidence of hernia recurrence following the application of Histoacryl® Lapfix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery.
- Trial name
- HISTOLAP (NCT06298500)
- Testing
- hernia repair surgery
- Where
- Spain
- Volunteers
- 443 people
- Sponsor
- Aesculap AG
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
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.
Inguinal Hernia, Femoral Hernia
Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap)
The purpose of this study is to evaluate the safety and performance of the 4DMESH® used in (robot-assisted) laparoscopic inguinal and femoral hernia repair.
- Trial name
- NCT05306496
- Testing
- Pre-shaped 4DMESH®
- Where
- 9 sites in Belgium, France and 1 more
- Volunteers
- 196 people
- Sponsor
- Cousin Biotech