Clinical trials: Mesh
End Stage Renal Failure on Dialysis, Hyperplasia
Safety Study of the Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access
The purpose of this study is to determine whether the long term use of the experimental Vascular Wrap(TM) Paclitaxel-Eluting Mesh is safe in the treatment of subjects needing hemodialysis access (via an expanded…
- Trial name
- NCT01033357
- Testing
- Graft, Vascular Wrap, Lifespan® ePTFE Vascular Graft Only
- Where
- 30 sites in United States
- Volunteers
- 222 people
- Sponsor
- Angiotech Pharmaceuticals
Chronic Hepatitis C Virus
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects…
- Trial name
- ION-2 (NCT01768286)
- Testing
- LDV/SOF, RBV
- Where
- 53 sites in United States
- Volunteers
- 441 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus
Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
This study is to to evaluate the safety, tolerability, and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) in Egyptian adults with genotype 4 hepatitis C virus (HCV) infection.
- Trial name
- NCT01838590
- Testing
- SOF, RBV
- Where
- 2 sites in Egypt
- Volunteers
- 103 people
- Sponsor
- Gilead Sciences
Rectal Prolapse
Safety and Performance Evaluation of a Biological Matrix Used for Rectal Prolapse Repair by Ventral Rectopexy
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Rectopexy membrane used in rectal prolapse repair by ventral rectopexy and to identify emerging risks in…
- Trial name
- NCT04130555
- Testing
- CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)
- Where
- 3 sites in France
- Volunteers
- 55 people
- Sponsor
- Meccellis Biotech
Pelvic Organ Prolapse
Xenform Postmarket Surveillance Study
To compare transvaginal repair with a biologic graft to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
- Trial name
- Xenform (NCT01945580)
- Testing
- Prolapse Repair
- Where
- 25 sites in United States
- Volunteers
- 374 people
- Sponsor
- Boston Scientific Corporation
Fecal Incontinence
Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.
- Trial name
- TRANSFORM (NCT01090739)
- Testing
- TOPAS Treatment for Fecal Incontinence
- Where
- 14 sites in United States
- Volunteers
- 207 people
- Sponsor
- ASTORA Women's Health
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.
Proctitis, Proctosigmoiditis
Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who…
- Trial name
- NCT01008410
- Testing
- Budesonide
- Where
- 63 sites in United States
- Volunteers
- 265 people
- Sponsor
- Bausch Health Americas, Inc.
Pelvic Organ Prolapse
Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse
This prospective, multi center cohort trial aims to evaluate the efficacy and safety of hysteropexy using Splentis via the vaginal route in primary uterine prolapse
- Trial name
- SAXO (NCT05042453)
- Testing
- Splentis® POP Tissue Anchoring System
- Where
- 7 sites in Germany
- Volunteers
- 140 people
- Sponsor
- Promedon
Hernia
International Hernia Mesh Registry
This is an open-label, multi-center, long-term, prospective hernia mesh registry. A minimum of 4,800 hernia patients will be enrolled from approximately 60 active sites globally
- Trial name
- IHMR (NCT00622583)
- Where
- 54 sites in United States, Australia and 11 more
- Volunteers
- 5,179 people
- Sponsor
- Ethicon, Inc.
Hernia, Inguinal
Comparative Study of Safety and Efficacy of Heavyweight and Partially Absorbable Mesh in Inguinal Hernia Repair
Proflex® Mesh (partially absorbable mesh, Korea) and Marlex® Mesh (heavyweight mesh) will be used for inguinal hernia repair to compare the safety and efficacy (pain score, quality of life)of two devices at 3 months follow-up.
- Trial name
- NCT01877122
- Testing
- Proflex® Mesh Mesh implantation, Marlex® Mesh Implant
- Where
- South Korea
- Volunteers
- 50 people
- Sponsor
- Samyang Biopharmaceuticals Corporation
Prolapse, Sacrocolpopexy
Retrospective Data Analysis PelviGYNious/EndoGYNious
The retrospective patient chart review aims to generate additional data to substantiate the safety and performance of EndoGYNious and PelviGYNious.
- Conditions
- Prolapse, Sacrocolpopexy, Pelvic Organ Prolapse (POP)
- Trial name
- NCT06927752
- Testing
- PelviGYNious, EndoGYNious
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
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 Hernia
Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair
A multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in subjects undergoing ventral hernia repair to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and…
- Trial name
- PPDS (NCT03495154)
- Testing
- Parietene DS Composite Mesh
- Where
- 6 sites in United States
- Volunteers
- 145 people
- Sponsor
- Medtronic - MITG
Pelvic Organ Prolapse
Restorelle® Mesh Versus Native Tissue Repair for Prolapse
The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle.
- Trial name
- NCT02162615
- Testing
- Restorelle Direct Fix A, Restorelle Direct Fix P, Native Tissue Repair Anterior
- Where
- 49 sites in United States, Australia and 4 more
- Volunteers
- 810 people
- Sponsor
- Coloplast A/S
Abdominal Wall Defect, Abdominal Wall Injury
Safety and Clinical Performance of a Biological Matrix Used in Abdominal Wall Reconstruction
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma…
- Conditions
- Abdominal Wall Defect, Abdominal Wall Injury, Abdominal Hernia
- Trial name
- PMCF_AWR (NCT04580511)
- Testing
- CELLIS (Porcine Acellular Dermal Matrix, PADM)
- Where
- 4 sites in France
- Volunteers
- 92 people
- Sponsor
- Meccellis Biotech
Hernia, Inguinal
Parietex Progrip Study
The objective of the study is to evaluate pain and disabling complications inducing social consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair with lightweight polypropylene mesh.
- Trial name
- NCT00827944
- Testing
- Parietex Progrip, Low weight polypropylene mesh
- Where
- 9 sites in Belgium, Germany and 3 more
- Volunteers
- 603 people
- Sponsor
- Medtronic - MITG
Abdominal Aortic Aneurysm, Morbid Obesity
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
The aim of the study is to describe the effectiveness of Optilene® Silver Mesh Elastic on prevention of surgical site infection (SSI) at 6 months follow-up in patients undergoing urgent laparotomy by collecting clinical data on…
- Trial name
- SSIHLVER (NCT06547138)
- Testing
- Prophylactic mesh
- Where
- 5 sites in Spain
- Volunteers
- 110 people
- Sponsor
- Aesculap AG
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
Degenerative Disc Disease
Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion.
The purpose of this study is to determine the clinical success of DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two levels of degenerative disc disease of the…
- Trial name
- NCT00215319
- Testing
- Lumbar I/F with cage and pedicle screws
- Where
- 2 sites in United States
- Volunteers
- 139 people
- Sponsor
- DePuy Spine