Clinical trials: Hernia Repair
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.
Ventral Hernia
Pain and Quality of Life After Retromuscular Ventral Hernia Repair (RECOVER)
The study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted retromuscular ventral hernia repair.
- Trial name
- RECOVER (NCT04487522)
- Testing
- Open retromuscular ventral hernia repair, Laparoscopic retromuscular ventral hernia repair, Robotic-assisted retromuscular ventral hernia repair
- Where
- 4 sites in United States
- Volunteers
- 74 people
- Sponsor
- Intuitive Surgical
Inguinal Hernia Repair
Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System
The purpose of this post-market, observational study is to collect data under anticipated conditions of use that demonstrates that DEXTER performs as intended in the intended patient population, including a variety of…
- Trial name
- RAS-ACCESS (NCT07181876)
- Testing
- inguinal hernia repair
- Where
- 2 sites in United States
- Volunteers
- 140 people
- Sponsor
- Distalmotion SA
Hernia
A Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation
This will be an observational study designed to collect early, short- and long-term clinical outcomes of the XenMatrix™ Surgical Graft for complex ventral hernia repair.
- Trial name
- XenMatrix (NCT01305486)
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- C. R. Bard
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
Hernia, Surgical Wound Dehiscence
Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR)
The objective of this study is to compare the incidence of post-repair wound related complications, including hernia occurrence/recurrence, between challenging abdominal wall defects repaired with Strattice(TM) Reconstructive…
- Trial name
- StAR (NCT01083472)
- Testing
- Strattice(TM) Reconstructive Tissue Matrix, Suture/suture with absorbable mesh
- Where
- 29 sites in France, Germany and 4 more
- Volunteers
- 37 people
- Sponsor
- LifeCell
Postoperative Urinary Retention
Preoperative Administration of Tamsulosin for Prevention of Post Operative Urinary Retention in Males Undergoing Elective Inguinal Hernia Repair
Double blinded, randomized controlled prospective study looking at 2 preoperative doses of Tamsulosin an alpha-adrenergic blocker in preventing post-operative urinary retention.
- Trial name
- NCT02958878
- Testing
- Tamsulosin
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Ascension Health
Hernia
TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study
The purpose of this study is to capture preliminary clinical safety and performance on the TAHRS
- Trial name
- NCT06042205
- Testing
- TISSIUM™ Atraumatic Hernia Repair System (TAHRS)
- Where
- 5 sites in Belgium, Spain
- Volunteers
- 78 people
- Sponsor
- Tissium
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
Inguinal and Ventral Hernia Repair by Sublay, Underlay and IPOM Mesh Fixation
Effectiveness, Appropriateness and Safety of GLUTACK-Glubran Tiss 2 Surgical Glue Compared to GLUTACK-Glubran 2 Device System for Mesh Fastening in Laparoscopic and Robotic Hernia Surgery
This pre-market, prospective, randomized, non-inferiority clinical study was designed to evaluate the safety and performance/effectiveness of Glutack-Glubran® Tiss 2 system compared to Glutack-Glubran® used for mesh fixation in…
- Trial name
- AGluTHeMFix (NCT06462066)
- Testing
- Experimental medical device, Comparator medical device
- Where
- Italy
- Volunteers
- 101 people
- Sponsor
- GEM SRL
Hernia, Ventral, Hernia, Inguinal
Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh
This study is designed to evaluate the post-operative complications and hernia recurrence following the use of OviTex in subjects with ventral or inguinal hernias.
- Trial name
- BRAVOII (NCT04779918)
- Testing
- OviTex Reinforced Tissue Matrix
- Where
- 10 sites in United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Tela Bio Inc
Hernia, Ventral, Hernia Incisional
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
The SYN 20-01 Study is a non-interventional, prospective, multicenter, multicohort, international, post-market clinical investigation looking into the assessment of GORE® SYNECOR Biomaterial in focused patient populations and in…
- Conditions
- Hernia, Ventral, Hernia Incisional, Hernia Incisional Ventral
- Trial name
- SYN 20-01 (NCT05094089)
- Testing
- Hernia repair with mesh
- Where
- 15 sites in United States, Italy and 2 more
- Volunteers
- 320 people
- Sponsor
- W.L.Gore & Associates
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
Cystocele, Rectocele
Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse
The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse.
- Conditions
- Cystocele, Rectocele, Enterocele
- Trial name
- NCT00833001
- Testing
- GYNECARE PROLIFT+M* Pelvic Floor Repair System
- Where
- 8 sites in Belgium, France and 2 more
- Volunteers
- 126 people
- Sponsor
- Ethicon, Inc.
Ventral Hernia
Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1
The purpose of the registry is to evaluate safety and efficacy of the Intramesh T1. This registry will collect data from 100 patients treated for a ventral hernia repair.
- Trial name
- NCT01816867
- Testing
- Intramesh T1 implantation
- Where
- Belgium
- Volunteers
- 96 people
- Sponsor
- be Medical
Diskectomy
Randomized Study of Anular Repair With the Xclose Tissue Repair System
The purpose of this study is to evaluate the benefits of anulus fibrosus repair utilizing Xclose™ compared to a discectomy without anulus fibrosus repair.
- Trial name
- NCT00760799
- Testing
- Discectomy with anular repair
- Where
- 34 sites in United States
- Volunteers
- 750 people
- Sponsor
- Anulex Technologies, Inc.
Ventral Hernia
Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch
This study will collect data on patients undergoing hernia repair using the Bard Ventrio Hernia Patch. The study will evaluate hernia recurrence rates, operating time, quality of life and complications associated with the device…
- Trial name
- NCT00866814
- Testing
- Bard Ventrio Hernia Patch
- Where
- 7 sites in United States
- Volunteers
- 119 people
- Sponsor
- C. R. Bard
Hernia, Hernia, Ventral
Transorb™ Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral Hernia
The purpose of RECOVER is to evaluate the performance and safety of Transorb™ self-gripping resorbable mesh in high-risk subjects (at least one risk factor impairing wound healing) when used for reinforcement of abdominal wall…
- Conditions
- Hernia, Hernia, Ventral, Hernia, Abdominal, Hernia Abdominal Wall
- Trial name
- RECOVER (NCT06449378)
- Testing
- Transorb™ Self-Gripping Resorbable Mesh
- Where
- 13 sites in United States, Belgium and 1 more
- Volunteers
- 163 people
- Sponsor
- Medtronic - MITG
Incisional Hernia, Ventral Hernia
Flexible Composite Next Generation Tissue Separating Mesh in Laparoscopic Incisional/Ventral Hernia Repair
This is a multi-center, observational study of incisional/ventral hernia repair with NG-TSM laparoscopically. The study is not randomized and has a single treatment design assessing NG-TSM intra-operatively, its ease of use and…
- Trial name
- NCT01162564
- Testing
- NG-TSM
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Ethicon, Inc.
Pelvic Organ Prolapse
Exair® Versus Native Tissue Repair for Prolapse
The purpose of this study is to compare safety and effectiveness of the Exair Prolapse Repair System for treatment of pelvic organ prolapse to traditional native tissue repair through 36 months of follow-up.
- Trial name
- NCT02162628
- Testing
- Exair Prolapse Repair System, Total Native Tissue Repair
- Where
- 14 sites in United States, Canada
- Volunteers
- 79 people
- Sponsor
- Coloplast A/S