Clinical trials: Hernia
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
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.
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
Postoperative Pain, Inguinal Hernia
Efficacy, Safety and Pharmacokinetic Profile of a Collagen Bupivacaine Implant in Men After Open Mesh Herniorrhaphy
The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after herniorrhaphy.
- Trial name
- NCT00626886
- Testing
- Bupivacaine Collagen Sponge
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Innocoll
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
Feasibility of Permacol Use in Infected Fields
This pilot study is to examine the feasibility of using Permacol Surgical Implant in the repair of abdominal wall defects after removal of infected prosthetic mesh
- Trial name
- NCT00820040
- Testing
- acellular porcine dermal collagen mesh
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Medtronic - MITG
Hernia, Postoperative Pain
Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy
This study will assess pain intensity for the first 72 hrs after aggravated movement (cough) following Laparoscopic Inguinal or Umbilical Herniorrhaphy.
- Trial name
- NCT01224145
- Testing
- 5x5cm bupivacaine collagen sponges
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Innocoll
Hernia, Hernia, Abdominal
Study of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair
The purpose of this study is to collect additional data on safety and performance of Phasix™ Mesh in subjects requiring Ventral Hernia Working Group (VHWG) Grade 3 midline hernia repair.
- Conditions
- Hernia, Hernia, Abdominal, Hernia, Incisional
- Trial name
- NCT02720042
- Testing
- Phasix™ Mesh
- Where
- 15 sites in Austria, Belgium and 6 more
- Volunteers
- 84 people
- Sponsor
- C. R. Bard
Inguinal Hernia Repair
A Trial of HR18034 in Inguinal Hernia Repair
Phase I, randomized, double-blind, comparator-controlled study to assess the safety, PK, and efficacy of single postsurgical application of HR18034 compared with Naropin®
- Trial name
- NCT04551924
- Testing
- HR18034, Naropin
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Inguinal Hernia
An Efficiency/Safety Study of Surgical Tissue Glue to Treat Inguinal Hernias
Prospective, multicenter, observational registry to collect data of laparoscopic inguinal hernia repair using surgical tissue glue fixation. The objective is to determine the prevalence of chronic pain at 1 year.
- Trial name
- NCT01669837
- Testing
- Mesh fixation with surgical tissue glue
- Where
- Belgium
- Volunteers
- 1,000 people
- Sponsor
- Duomed
Inguinal Hernia, Ventral Hernia
Post Market Clinical Follow Up Study for ReliaTack™ Articulating Reloadable Fixation Device With Deep Purchase Tacks
A post-market clinical follow-up study for ReliaTack™ articulating reloadable fixation device with deep purchase tacks
- Trial name
- RAFDT (NCT03526341)
- Testing
- ReliaTack™ Articulating Reloadable Fixation Device
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- Medtronic - MITG
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.
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
Hiatal Hernia
Miromatrix Biological Mesh for Hiatal Hernia Repair
Miromatrix Medical has developed MIROMESH® - a new, noncrosslinked, acellular mesh derived from the highly vascularized porcine liver.
- Trial name
- NCT02436681
- Testing
- MIROMESH
- Where
- 6 sites in United States
- Volunteers
- 50 people
- Sponsor
- Miromatrix Medical Inc.
Ileus
A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair
This study will evaluate the safety and efficacy of two different dose regimens (12 milligrams [mg] and 24 mg) of IV MOA-728 versus placebo in shortening the time to return of bowel function in participants receiving opioid…
- Trial name
- NCT00528970
- Testing
- MOA-728
- Where
- 106 sites in United States, Australia and 9 more
- Volunteers
- 374 people
- Sponsor
- Bausch Health Americas, Inc.
Gastroesophageal Reflux Disease, Hiatal Hernia
Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)
The study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients compared with sham procedure.
- Trial name
- NCT01110811
- Testing
- Transoral Incisionless Fundoplication (TIF)
- Where
- 4 sites in Belgium, France and 1 more
- Volunteers
- 60 people
- Sponsor
- EndoGastric Solutions
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
Hernia
Safety Study of MotifMESH (cPTFE) in Abdominal Surgery
This study will monitor surgically repaired large abdominal hernias requiring condensed fenestrated polytetrafluoroethylene mesh (cPTFE).
- Trial name
- NCT01364233
- Testing
- MotifMESH
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Medline Industries
General Laparoscopic Surgery Candidate, Bariatric Laparoscopic Surgery Candidate
Usability and Performance Evaluation of the AutoLap System - a Feasibility Study
The main objectives of this study are to evaluate the ease of use and performance of the AutoLap system compared to human camera holder during general and bariatric laparoscopic surgeries.
- Trial name
- NCT02346552
- Testing
- AutoLap
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- M.S.T. Medical Surgery Technology LTD.
General Laparoscopic Surgeries
Comparison of Laparoscopic Procedures With and Without the Aid of the AutoLap System- a Robotic Camera Holder
The objective of this study is to evaluate the ability to reduce the number of OR personnel required while performing the following procedures: colon resections, cholecystectomies and anti-reflux/hiatal hernia surgery with the…
- Trial name
- NCT02934542
- Testing
- AutoLap system
- Where
- Netherlands
- Volunteers
- 108 people
- Sponsor
- M.S.T. Medical Surgery Technology LTD.