Clinical trials: Hernia Repair
Inguinal Hernia
Pain and Quality of Life After Inguinal Hernia Repair
This study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted inguinal hernia repair.
- Trial name
- PREPARE (NCT04074200)
- Testing
- Open Inguinal Hernia Repair, Laparoscopic Inguinal Hernia Repair, Robotic-Assisted Inguinal Hernia Repair
- Where
- United States
- Volunteers
- 156 people
- Sponsor
- Intuitive Surgical
Inguinal Hernia
Safety and Performance Study of TIGR Matrix Surgical Mesh in Inguinal Hernia Repair
This an open, uncontrolled multicenter clinical study to assess the safety and performance of the WK-6 surgical mesh in adult patients with unilateral inguinal hernia.
- Trial name
- NCT01193985
- Testing
- TIGR Matrix Surgical Mesh
- Where
- 2 sites in Sweden
- Volunteers
- 40 people
- Sponsor
- Novus Scientific
Robotic Assisted Inguinal Hernia Repair
Versius Clinical Study in Robot Assisted Inguinal Hernia Repair Surgery
The objective of this clinical trial is to evaluate the safety and efficacy of Versius in Inguinal Hernia repair surgery
- Trial name
- NCT07316517
- Testing
- Versius Surgical System
- Where
- 2 sites in Italy, Spain
- Volunteers
- 30 people
- Sponsor
- CMR Surgical Ltd
Ventral Hernia
Miromatrix Biological Mesh for Ventral Hernia Repair
This study is being conducted to gather long-term data of the performance of the Miromatrix Biological Mesh.
- Trial name
- MIROMESH PM-1 (NCT02408458)
- Testing
- MIROMESH®
- Where
- 4 sites in United States
- Sponsor
- Miromatrix Medical Inc.
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 Hernias, Incisional Hernias
Antimicrobial Hernia Repair Device
This prospective early feasibility clinical study will collect information regarding the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device to reinforce soft tissue during ventral or incisional hernia repair in…
- Trial name
- NCT02730936
- Testing
- Antimicrobial Hernia Repair Device
- 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
Inguinal Herniorrhaphy
A Phase 2, Randomized, Double-Blind, Dose Escalation Study in Postoperative Pain Open Inguinal Herniorrhaphy
This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing open inguinal herniorrhaphy with mesh.
- Trial name
- NCT05080959
- Testing
- CPL-01, Naropin 150 MG Per 20 ML Injection
- Where
- 5 sites in United States
- Volunteers
- 105 people
- Sponsor
- Cali Pharmaceuticals LLC
Hernia, Paraesophageal Hernia
Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS)
The purpose of this randomized study is to determine whether a type of mesh derived from a layer of pig small intestine (SIS) is of benefit in treating paraesophageal hernias versus standard surgical suture repair.
- Trial name
- NCT00272922
- Testing
- hernia repair
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Cook Group Incorporated
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
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 Repair, Hernia Inguinal
Postsurgical Analgesia After Hernia Repair
The study is designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of three ascending doses of AMT-143 to determine the appropriate dose of AMT-143 for the management of postsurgical pain following inguinal hernia…
- Conditions
- Hernia Repair, Hernia Inguinal, Hernia Surgery, Hernia, Inguinal/Surgery
- Trial name
- NCT06709612
- Testing
- AMT-143, ropivacaine
- Sponsor
- AmacaThera 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
Hernia
A Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft
This study will enroll subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past.
- Trial name
- AlloMax (NCT01205399)
- Where
- 5 sites in United States
- Volunteers
- 78 people
- Sponsor
- C. R. Bard
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
Pelvic Organ Prolapse
Restorelle® Mesh Versus Native Tissue Repair for Prolapse
The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle.
- Trial name
- NCT02162615
- Testing
- Restorelle Direct Fix A, Restorelle Direct Fix P, Native Tissue Repair Anterior
- Where
- 49 sites in United States, Australia and 4 more
- Volunteers
- 810 people
- Sponsor
- Coloplast A/S
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.
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.
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
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