Clinical trials: Hernia
Fundoplication
Hernia Reduction Prior to Scheduled TIF Completion
Hernia Reduction Prior to Scheduled TIF Completion using EsophyX ZR transoral device
- Trial name
- HEURISTIC (NCT03280121)
- Testing
- EsophyX ZR transoral device
- Where
- 3 sites in United States
- Volunteers
- 14 people
- Sponsor
- EndoGastric Solutions
Hernia, Ventral, Hernia, Hiatal
GORE® ENFORM Biomaterial Product Study
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair).
- Conditions
- Hernia, Ventral, Hernia, Hiatal, Hernia, Diaphragmatic, Incisional Hernia
- Trial name
- ENF 18-06 (NCT04718168)
- Testing
- Gore ENFORM Biomaterial (Preperitoneal), Gore ENFORM Biomaterial (Intraperitoneal)
- Where
- 9 sites in United States
- Volunteers
- 245 people
- Sponsor
- W.L.Gore & Associates
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
Comparison of Patient Perceived Pain and Satisfaction Between Lightweight and Heavyweight Mesh for Laparoscopic Inguinal Hernia Repair
This study will be comparing the patients overall satisfaction of two different meshes used in laparoscopic inguinal hernia repairs.
- Trial name
- NCT01638221
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Ascension Health
Sciatica
Study to Evaluate the Safety and Efficacy of Placulumab (CEP-37247) Administered by the Transforaminal Epidural Route for the Treatment of Patients With Lumbosacral Radicular Pain Associated With Disk Herniation
The primary objective of the study is to evaluate the safety and efficacy of CEP-37247 compared with placebo as assessed by the occurrence of adverse events, and the mean change in average pain intensity (API) in the affected leg.
- Trial name
- NCT01240876
- Testing
- CEP-37247
- Where
- 24 sites in United States, Australia
- Volunteers
- 98 people
- Sponsor
- Cephalon
Chronic Low-back Pain, Herniated Disc
LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
The study is a post-market surveillance study of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device, which is used to treat low-back pain that accompanies degenerative lesions of grades II, III, and IV…
- Conditions
- Chronic Low-back Pain, Herniated Disc, Degenerative Disc Disease, Lumbar Canal Stenosis
- Trial name
- LISA-PMCF (NCT04631133)
- Testing
- Lumbar Implant for Stiffness Augmentation (LISA)
- Where
- 5 sites in Denmark, France and 1 more
- Volunteers
- 136 people
- Sponsor
- BACKBONE
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, Inguinal
Early Surgeon Experience With Robotic-Assisted Inguinal Hernia Repair
The primary objective of this study is to evaluate the progression of surgeon efficiency and proficiency of traditionally open or laparoscopic surgeons performing robotic-assisted inguinal hernia repair throughout their learning…
- Trial name
- NCT04353687
- Testing
- Robotic-assisted inguinal hernia repair
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Intuitive Surgical
Lumbar Disc Herniation
PMCFU of an Annular Closure System
The purpose of this retrospective chart review study is to collect the data that will be used to provide clinical evidence to support the post-market surveillance program.
- Trial name
- NCT05467072
- Testing
- Annular closure
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Intrinsic Therapeutics
Discopathy, Herniated Cervical Disc
Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C
Study design: International, prospective, multicentre, non-randomised, observational study according to § 23b MPG. Objectives: Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE®-C.
- Conditions
- Discopathy, Herniated Cervical Disc, Stenoses, Spinal, Radiculopathy
- Trial name
- PMCF_MOVE®-C (NCT05035693)
- Testing
- MOVE®-C
- Where
- 7 sites in Austria, Germany
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- NGMedical GmbH
Hernia, Inguinal, Flat Foot
The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population
Randomized, multi-center, double-blind, two-armed, parallel active groups, prospective trial to evaluate the efficacy and safety of local anesthetic Chloroprocaine at two different concentrations ( at 1% and 2%) in a pediatric…
- Trial name
- NCT03918798
- Testing
- Chloroprocaine 1% Injectable Solution, Chloroprocaine 2% Injectable Solution
- Where
- 9 sites in Italy, Spain
- Volunteers
- 164 people
- Sponsor
- Sintetica SA
Post Abdominal Surgery Pain
A Study Evaluating the Overall Pain Relief and Safety of Intravenous (IV) CR845 in Patients Undergoing Abdominal Surgery
The study schedule is comprised of a 14-day Screening Period, a treatment period and an observation period. All eligible subjects will be randomized into one of 3 treatment groups (1 of 2 dose levels or matched placebo).
- Trial name
- NCT02542384
- Testing
- CR845 IV 1 mcg/kg, CR845 IV 0.5 mcg/kg
- Where
- 23 sites in United States
- Volunteers
- 451 people
- Sponsor
- Cara Therapeutics, Inc.
Hernia
Large Abdominal Hernia Repair With SurgiMend 3.0
The rate of hernia recurrence at one year following repair of a large abdominal hernia with a biologic mesh is high, ranging from 30% to 100%, with a reported historic average rate of 40%.
- Trial name
- BRIDGE (NCT00892333)
- Where
- 8 sites in United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Integra LifeSciences Corporation
Degenerative Disc Disease, Spinal Stenosis
Burst Biologics Spinal Fusion Registry
A multicenter patient registry was created with aim of documenting how spine and neurosurgeons are utilizing Burst Biologics products along with patient outcomes.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylitis, Spondylolisthesis
- Trial name
- NCT03064802
- Testing
- BioBurst Fluid, Burst Allograft
- Where
- 4 sites in United States
- Volunteers
- 450 people
- Sponsor
- Burst Biologics
Hernia
AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE
The primary purpose of this clinical trial is to assess the safety and performance of the ECLIPSIUM device in securing mesh during ventral hernia repair.
- Trial name
- UNITE (NCT07277946)
- Testing
- ECLIPSIUM® System, Resorbable tacks (AbsorbaTack/SorbaFix)
- Where
- 12 sites in United States
- Volunteers
- 240 people
- Sponsor
- Tissium
Incisional Hernia Repair
Comparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair
Optilene® Mesh Elastic and Ultrapro® Mesh will be used for incisional hernia repair. The primary objective of this clinical study is to demonstrate that Optilene® Mesh Elastic is superior to Ultrapro® Mesh in incisional hernia…
- Trial name
- Optilene (NCT00646334)
- Testing
- Mesh Implantation
- Where
- 6 sites in Germany
- Volunteers
- 80 people
- Sponsor
- Aesculap AG
Disk Herniated Lumbar
Safety and Performance of a Hernia Blocking System
Prospective, multi-center, single-arm clinical study to assess the performance of an Hernia Blocking System in preventing clinically symptomatic recurrent lumbar disc herniation.
- Trial name
- NCT04188236
- Testing
- Hernia Blocking System
- Where
- 6 sites in Spain
- Volunteers
- 30 people
- Sponsor
- NEOS Surgery
Analgesia
Extended Delivery of Bupivacaine Study in Herniorrhaphy
This is a phase 4, randomized, open-label study of the efficacy, safety, and pharmacokinetics of bupivacaine administered as liposomal bupivacaine or continuous infusion via elastomeric pump following unilateral open inguinal…
- Trial name
- NCT04102267
- Testing
- Bupivacaine liposome injectable suspension, Bupivacaine HCl without epinephrine via continuous infusion
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Heron Therapeutics
Open Midline Laparotomy
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for…
- Trial name
- PREVENT (NCT03911700)
- Testing
- Phasix™ Mesh
- Where
- 32 sites in United States, Austria and 3 more
- Volunteers
- 477 people
- Sponsor
- C. R. Bard
Inguinal Hernia, Postoperative Pain
Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair
A multicenter, single-dose study in children 12 to <17 years of age, 6 to <12 years of age, and 2 to <6 years of age who are scheduled for elective open inguinal hernia repair.
- Trial name
- NCT03262688
- Testing
- Bupivacaine HCl collagen-matrix implant, Bupivacaine HCl infiltration
- Where
- 11 sites in United States
- Volunteers
- 159 people
- Sponsor
- Innocoll