Clinical trials: Hernia Surgery
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
Ventral Hernia
Hernia Repair in Multiply Morbid Patients
Support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in a diminished rate of hernia recurrence.
- Trial name
- RAM2P (NCT00930787)
- Testing
- Strattice Reconstructive Tissue Matrix (Hernia Repair), Proceed Surgical Mesh (Hernia repair)
- Where
- 13 sites in United States
- Volunteers
- 23 people
- Sponsor
- LifeCell
Hernia, Hernia, Ventral
T-GENVIH-003 LTFU (Long Term Follow Up) Study
The T-GENVIH-003 study will collect additional, longer term performance data of Gentrix® Surgical Matrix used for reinforcement of ventral hernia repairs from a subset population (i.e., the twenty-one minimally invasive surgical…
- Conditions
- Hernia, Hernia, Ventral, Pathological Conditions, Anatomical, Hernia, Abdominal
- Trial name
- NCT06034652
- Testing
- Integra® Gentrix® Surgical Matrix
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Integra LifeSciences Corporation
Analgesia
Study of Post-Herniorrhaphy Non-opioid MMA Regimens
This is a Phase 3b, open-label study to assess postoperative opioid use in subjects undergoing unilateral open inguinal herniorrhaphy with intraoperative administration of HTX-011 and a postoperative non-opioid multimodal…
- Trial name
- NCT03907176
- Testing
- HTX-011, Luer lock applicator, Ibuprofen
- Where
- 30 sites in United States
- Volunteers
- 209 people
- Sponsor
- Heron Therapeutics
Parastomal Hernia
Parastomal Reinforcement With Strattice
The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of…
- Trial name
- PriSm (NCT00771407)
- Testing
- Strattice Reconstructive Matrix, Standard ostomy creation
- Where
- 23 sites in United States
- Volunteers
- 120 people
- Sponsor
- LifeCell
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
Gastroesophageal Reflux Disease, Hiatal Hernia
Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study
The objective of the study is to evaluate the relative merits, safety and effectiveness of the EsophyX transoral device in performing an advanced TIF procedure in patients with "troublesome symptoms" as defined by the Montreal…
- Trial name
- RESPECT (NCT01136980)
- Testing
- TIF Transoral Fundoplication
- Where
- 9 sites in United States
- Volunteers
- 129 people
- Sponsor
- EndoGastric Solutions
Bariatric Surgery Candidate, Hiatal Hernia
Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device
The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the…
- Trial name
- NCT06432088
- Testing
- Extended Magnetic Grasper Device
- Where
- Chile
- Volunteers
- 30 people
- Sponsor
- Levita Magnetics
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.
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
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 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
Obstructive Defecation Syndrome, Chronic Constipation
Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)
The primary purpose of this study is to determine how effective and how durable STARR (stapled transanal rectal resection) surgery is in relieving symptoms of intractable constipation associated with obstructive defecation…
- Conditions
- Obstructive Defecation Syndrome, Chronic Constipation, Rectocele, Intussusception
- Trial name
- NCT00256984
- Testing
- Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler
- Where
- 7 sites in United States
- Volunteers
- 75 people
- Sponsor
- Ethicon Endo-Surgery
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
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
Strattice in Repair of Inguinal Hernias
This is a prospective, randomized, controlled, third-party blinded, multicenter, interventional evaluation of inguinal hernia repair comparing Strattice to light weight polypropylene mesh.
- Trial name
- RING (NCT00681291)
- Testing
- Inguinal hernia repair with Ultrapro, Inguinal hernia repair with Strattice
- Where
- 8 sites in United States
- Volunteers
- 172 people
- Sponsor
- LifeCell
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.
Vaginal Prolapse
Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products
This registry was observational (only collected information typically noted by the surgeon when their patients were routinely seen); there was no change to the care the patient received as a result of being part of the registry).
- Trial name
- POWER1012 (NCT00388947)
- Testing
- AMS Prolapse Product
- Where
- United States
- Volunteers
- 1,543 people
- Sponsor
- ASTORA Women's Health
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
Hernia, Obesity
Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery
The primary objective is to compare the effectiveness of the Surgisis Gold Graft to suture closure alone in preventing an incisional hernia after open bariatric surgery.
- Trial name
- NCT00274625
- Testing
- Surgisis Gold Graft, Control
- Where
- 2 sites in United States
- Volunteers
- 402 people
- Sponsor
- Cook Group Incorporated