Clinical trials: Hernia
Incisional Hernia
Xen Matrix™ AB Surgical Graft in Ventral or Incisional Midline Hernias
This study aims to prospectively explore the use of XenMatrix™ AB Surgical Graft for ventral or incisional midline hernia repair in patients across all wound classes ("All Comers") through 24 months post repair.
- Trial name
- NCT02691962
- Testing
- Xen Matrix AB
- Where
- 11 sites in United States
- Volunteers
- 75 people
- Sponsor
- C. R. Bard
Inguinal Hernia
Determine the Clinical Advantage of IV vs PO Acetaminophen
There is limited research on the clinical outcome differences between intravenous (IV) acetaminophen versus oral (PO) acetaminophen.
- Trial name
- NCT03558555
- Testing
- Acetaminophen IV Soln, Oral Acetaminophen, Saline
- Where
- United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Yan Lai
Inguinal Hernia
Urinary Retention After Laparoscopic Inguinal Hernia Repair: Comparing the Use of the Intraoperative Urinary Catheter
This will be a randomized controlled study which will compare the rate of post-operative urinary retention after laparoscopic inguinal hernia repair between patients who receive an intra-operative urinary catheter and those who…
- Trial name
- NCT03835351
- Testing
- Urinary Catheter
- Where
- United States
- Volunteers
- 491 people
- Sponsor
- The Cleveland Clinic
Lumbar Degenerative Disc Disease
TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study
The purpose of this investigation is to evaluate the safety and effectiveness of the TRIUMPH® Lumbar Artificial Disc for the treatment of patients who are suffering from Degenerative Disc Disease (DDD) at one level from L1 to S1.
- Trial name
- NCT01198470
- Testing
- TRIUMPH® Lumbar Artificial Disc
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Globus Medical Inc
Inguinal Hernia
Neo-nervegenesis in Inguinal Hernia Implant ProFlor
The investigation is aimed at specifically demonstrating the ingrowth of newly formed nervous elements within a 3D dynamic responsive implant for inguinal hernia repair.
- Trial name
- NCT04171102
- Testing
- ProFlor Hernia implant
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of Cagliari
Low Back Pain, Lumbosacral Radiculopathy
A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief
The purpose of this study is to collect information about how patients feel when doctors manage their pain after lumbar spine surgery using a combination of EXPAREL® and bupivacaine injected into the lumbar spine at the end of…
- Conditions
- Low Back Pain, Lumbosacral Radiculopathy, Lumbar Disc Degeneration, Lumbar Disc Herniation
- Trial name
- NCT03514277
- Testing
- Exparel, Bupivacaine
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Virtua Health, Inc.
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
Lumbar Disc Herniation
A Study to Evaluate Safety and Exploratory Efficacy of KTP-001 in Subjects With Lumbar Disc Herniation
The purpose of this study is to evaluate the safety and exploratory efficacy of KTP-001 in subjects with lumbar disc herniation.
- Trial name
- NCT01978912
- Testing
- KTP-001
- Where
- 10 sites in United States
- Volunteers
- 24 people
- Sponsor
- Teijin America, Inc.
Gastroschisis
Direct Peritoneal Resuscitation in Gastroschisis
This is a prospective, double-arm study designed to evaluate the tolerability of direct peritoneal resuscitation (DPR) in neonates with gastroschisis.
- Trial name
- NCT03205553
- Testing
- SoC Staged Silo Closure, Peritoneal Dialysis Solution/Dextrose 1.5%
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Arkansas
Disc Herniation, Lumbosacral Radiculopathy
CT Guided Injection for Low Back Radiculopathy: A Randomized Clinical Trial
Herniated disc sometimes cause back pain radiating down to a leg. This pain can be so severe that it is functionally disabling. The purpose of this randomized clinical trial is to determine if corticosteroid medication, delivered…
- Trial name
- NCT01267825
- Testing
- CT-guided corticosteroid+ bupivicaine, Standard medical care
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Montefiore Medical Center
Inguinal Hernia, Postoperative Pain
Preoperative Etanercept Before Inguinal Hernia Surgery
Inguinal hernia repair is one of the most frequently performed operations in young men. Persistent pain after inguinal surgery represents a significant cause of disability, occurring in between 15%-35% of cases.
- Trial name
- NCT00825344
- Testing
- Etanercept, Saline
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- Johns Hopkins University
Lumbar Spine Degeneration
INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine
This investigation will provide safety and effectiveness information on the use of INFUSE® Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a Transforaminal Lumbar Interbody Fusion (TLIF) surgical…
- Trial name
- TLIF (NCT01415908)
- Testing
- INFUSE Bone Graft, Iliac Crest Bone Graft
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Medtronic Spinal and Biologics
Ventral Hernias
Abdominal Binder to Reduce Pain and Seroma Formation
Postoperative seroma formation is one of the most common complications after ventral hernia repair. Although some seromas may not have clinical impact, postoperative seroma formation often causes pain and discomfort and may even…
- Trial name
- ABD- BINDER (NCT01673568)
- Testing
- ETO garments
- Where
- Denmark
- Volunteers
- 56 people
- Sponsor
- Hvidovre University Hospital
Hernia, Abdominal, Abdominal Injuries
ENHANCE: A Prospective EvaluatioN of Permacol™ in tHe Repair of Complex AbdomiNal Wall CasEs
The objective of this prospective study is to evaluate short-term, mid-term, and long-term clinical outcomes associated with the use of Permacol™ Biological Implant in the treatment of complex abdominal wall defects
- Trial name
- ENHANCE (NCT01268514)
- Where
- 12 sites in Belgium, Germany and 3 more
- Volunteers
- 115 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
Obstructed Defecation Syndrome, Rectocele
Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM
The stapled transanal rectal resection (STARR procedure) is an effective treatment for obstructed defecation syndrome (ODS) caused by intussusception and rectocele.
- Conditions
- Obstructed Defecation Syndrome, Rectocele, Intussusception, SNS
- Trial name
- STARR (NCT00673400)
- Testing
- Stapled transanal rectum resection
- Where
- Switzerland
- Volunteers
- 52 people
- Sponsor
- Cantonal Hospital of St. Gallen
Ventral Hernia
Laparoscopic vs. Robotic Ventral Hernia Repair With IPOM
The investigators aim to conduct a registry-based, randomized controlled trial to investigate if the robotic platform for minimally invasive ventral hernia repair with intraperitoneal onlay mesh (IPOM), when compared to the…
- Trial name
- NCT03283982
- Testing
- Robotic Ventral Hernia Repair with IPOM, Laparoscopic Ventral Hernia Repair with IPOM
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- The Cleveland Clinic
Ventral Hernia
A Clinical Trial Using Spy Elite System in Planning Tissue Advancement Flaps After Ventral Hernia Repair
The purpose of this project is to assess the efficacy of the Spy Elite System (LifeCell Corporation, Branchburg, NJ, USA) in planning tissue advancement flaps and reducing wound complications after complex ventral hernia repairs.
- Trial name
- NCT01886963
- Testing
- SPY - Unblinded use of SPY Elite, Control - Blinded use of SPY Elite
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- Wake Forest University Health Sciences
Analgesia, Postoperative
Exparel vs. Bupivacaine Hydrochloride vs. Placebo for Hernia Repair
Patients usually experience some level of pain after their hernia repair. To control pain after the operation, surgeons have many options.
- Trial name
- NCT03541941
- Testing
- Exparel, Bupivacaine Hcl 0.25% Inj
- Where
- United States
- Volunteers
- 164 people
- Sponsor
- The Cleveland Clinic
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