Clinical trials: Hernia
Postsurgical Pain
Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair
A Three-Part, Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Adaptive Safety, Pharmacokinetics, and Preliminary Efficacy Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair
- Trial name
- NCT04774328
- Testing
- CA-008 (vocacapsaicin)
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Concentric Analgesics
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
Herniorrhaphy, Postoperative Pain
Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy
This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen…
- Conditions
- Herniorrhaphy, Postoperative Pain, Inguinal Hernia
- Trial name
- NCT01220024
- Testing
- Bupivacaine Collagen Sponge
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Innocoll
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
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
Herniated Disc, Radiculopathy
Slotted Hole Versus Fixed Hole C-Tek
The purpose of this study is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior Cervical Plate, Slotted Hole Design versus the Fixed Hole Design.
- Conditions
- Herniated Disc, Radiculopathy, Spondylolysis
- Trial name
- NCT00585923
- Testing
- Fixed hole C-Tek™ Plate, Slotted hole C-Tek™ Plate
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- Zimmer Biomet
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
Ventral Hernia, Incisional Hernia
A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair
Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.
- Trial name
- NCT02053168
- Testing
- Resorbable Mesh
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- C. R. Bard
Incisional Hernia
ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention
Interventional, prospective, multicenter, post-marketing clinical follow-up study. After midline laparotomy, the probability to develop an incisional hernia ranges from 10% to 50% depending on the complexity of the surgery and…
- Trial name
- POETRY (NCT03912662)
- Testing
- Mesh augmented reinforcement
- Where
- 11 sites in France
- Volunteers
- 32 people
- Sponsor
- Medtronic - MITG
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.
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
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
Ventral Hernia
Post-market Study of the Biodesign Hernia Graft
The purpose of this study is to collect data on the performance of the Biodesign® Hernia Graft when used to reinforce soft tissues during ventral hernia repair.
- Trial name
- NCT04294446
- Testing
- Biodesign Hernia Graft
- Where
- 3 sites in United States, Canada
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Cook Biotech Incorporated
Hernia, Inguinal Hernia
A Clinical Study to Evaluate the Clinical Performance and Safety of LiquiBand FIX8® Versus AbsorbaTack™ for Hernia Mesh Fixation and Peritoneal Closure in Groin Hernia Repair
This is a multi-center, randomized controlled trial of 284 subjects (142 in each group). Patients will be blinded to the fixation method used.
- Conditions
- Hernia, Inguinal Hernia, Femoral Hernia, Groin Hernia
- Trial name
- NCT04009213
- Testing
- LiquiBand FIX8®, AbsorbaTack™
- Where
- 6 sites in United States
- Volunteers
- 284 people
- Sponsor
- Advanced Medical Solutions Ltd.
Ventral Incisional Hernia
The SymCHro - Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair
The aim of this Observational Registry Study is to assess the short- and long-term clinical outcomes following the use of Symbotex™ Composite Mesh in primary and incisional abdominal wall hernia surgeries by open or laparoscopic…
- Trial name
- SymCHro (NCT02206828)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Medtronic - MITG
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
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
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
Inguinal Hernia Study Using Biodesign IHM
Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective…
- Trial name
- NCT00393887
- Testing
- Biodesign IHM, Polypropylene mesh
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Cook Group Incorporated
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