Clinical trials: Ventral Hernias
Ventral Hernia
A Comparison of Fortiva and Strattice Tissue Matrices in Complex, Ventral Hernia Repair
The objective of this study is to compare the effectiveness of Fortiva Porcine Dermis versus Strattice Reconstructive Tissue Matrix for the underlay reinforcement of complex ventral hernia repair and assess post-operative…
- Trial name
- NCT02587403
- Testing
- Fortiva™ Porcine Dermis, Strattice™ Reconstructive Tissue Matrix
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- RTI Surgical
Abdominal Wall Defect, Ventral Hernia
Clinical Study on the Safety of SAFIL® MESH
Observational, Retrospective, Multi-center Clinical Study on the Safety of SAFIL® MESH in Patients Undergoing Reinforcement of Soft Tissues After Abdominal Wall Surgery or Other Fascial Defects
- Conditions
- Abdominal Wall Defect, Ventral Hernia, Abdominal Hernia, Fascial Hernia
- Trial name
- SAFIL_MESH (NCT04947202)
- Testing
- Hernioplasty
- Where
- 2 sites in Spain
- Volunteers
- 152 people
- Sponsor
- Aesculap AG
Hernia
Veritas in Non-Bridging Ventral Hernia Repair
The main study objective is to determine the frequency of hernia recurrence following use of Veritas Collagen Matrix.
- Trial name
- VIBE (NCT01426477)
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- Baxter Healthcare Corporation
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
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
A Prospective Study in Patients Undergoing Primary Ventral Hernia Repair Using Parietex™ Composite Ventral Patch
The objective of this study is to assess the recurrence rate following the use of PARIETEX™ Composite Ventral Patch in primary ventral hernia repair by open approach with intra-peritoneal positioning.
- Trial name
- Panacea (NCT01848184)
- Testing
- PARIETEX™ Composite Ventral Patch
- Where
- 10 sites in United States, Belgium and 2 more
- Volunteers
- 126 people
- Sponsor
- Medtronic - MITG
Pain, Postoperative, Hernia, Ventral
An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries
This is a multicenter, Phase 3, open-label, safety, tolerability, and characterization of pharmacokinetics study of the INL 001 (bupivacaine HCl) implant, at 300 mg, in patients following various soft-tissue surgeries: open…
- Conditions
- Pain, Postoperative, Hernia, Ventral, Abdominoplasty, Hysterectomy
- Trial name
- NCT04785638
- Testing
- INL-001 (bupivacaine hydrochloride) implant
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- Innocoll
Ventral Hernia
Anovo Surgical System in Ventral Hernia
The study is aimed to clinically assess the AnovoTM Surgical System in ventral hernia procedures. Extensive preclinical testing of the system's integrity and safety has been performed to assure adequate safety for this trial.
- Trial name
- CLEVER (NCT06457971)
- Testing
- Robotic Ventral Hernia Repair
- Where
- 2 sites in Belgium, Israel
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Momentis Surgical
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
Nutritional Deficiency
Dose-response Enteral Citrulline for Normal Healthy Volunteers and Surgery Patients
To determine the level of citrulline to produce a given amount of arginine in healthy volunteers and surgical patients. Arginine-related amino acids are expected to increase as a result of increased substrate provided by…
- Trial name
- NCT00950976
- Testing
- citrulline, Lemonade
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Inguinal and Ventral Hernia Repair by Sublay, Underlay and IPOM Mesh Fixation
Effectiveness, Appropriateness and Safety of GLUTACK-Glubran Tiss 2 Surgical Glue Compared to GLUTACK-Glubran 2 Device System for Mesh Fastening in Laparoscopic and Robotic Hernia Surgery
This pre-market, prospective, randomized, non-inferiority clinical study was designed to evaluate the safety and performance/effectiveness of Glutack-Glubran® Tiss 2 system compared to Glutack-Glubran® used for mesh fixation in…
- Trial name
- AGluTHeMFix (NCT06462066)
- Testing
- Experimental medical device, Comparator medical device
- Where
- Italy
- Volunteers
- 101 people
- Sponsor
- GEM SRL
Ventral Hernia
Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch
This study will collect data on patients undergoing hernia repair using the Bard Ventrio Hernia Patch. The study will evaluate hernia recurrence rates, operating time, quality of life and complications associated with the device…
- Trial name
- NCT00866814
- Testing
- Bard Ventrio Hernia Patch
- Where
- 7 sites in United States
- Volunteers
- 119 people
- Sponsor
- C. R. Bard
Ventral Hernia
Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1
The purpose of the registry is to evaluate safety and efficacy of the Intramesh T1. This registry will collect data from 100 patients treated for a ventral hernia repair.
- Trial name
- NCT01816867
- Testing
- Intramesh T1 implantation
- Where
- Belgium
- Volunteers
- 96 people
- Sponsor
- be Medical
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
Hernia, Ventral, Hernia, Inguinal
Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh
This study is designed to evaluate the post-operative complications and hernia recurrence following the use of OviTex in subjects with ventral or inguinal hernias.
- Trial name
- BRAVOII (NCT04779918)
- Testing
- OviTex Reinforced Tissue Matrix
- Where
- 10 sites in United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Tela Bio Inc
Ventral Hernia
AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair
Medtronic is sponsoring and funding the AFFIX study, a prospective, post-market, multicenter, nonrandomized, single-arm, interventional clinical study.
- Trial name
- AFFIX (NCT06710795)
- Testing
- MaxTack™ Motorized Fixation Device
- Where
- 3 sites in United States
- Volunteers
- 35 people
- Sponsor
- Medtronic - MITG
Ventral Hernia, Incisional Hernia
A Prospective Study of Fortiva in Hernia Repair
The goal of this study is to evaluate safety and performance of the Fortiva Tissue Matrix. Participants will complete questionnaires to measure outcomes after hernia surgery for two years.
- Conditions
- Ventral Hernia, Incisional Hernia, Abdominal Wall Reconstruction
- Trial name
- NCT06101979
- Testing
- Fortiva Tissue Matrix
- Where
- United Kingdom
- Volunteers
- 120 people
- Sponsor
- RTI Surgical
Ventral Hernia
Pain and Quality of Life After Retromuscular Ventral Hernia Repair (RECOVER)
The study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted retromuscular ventral hernia repair.
- Trial name
- RECOVER (NCT04487522)
- Testing
- Open retromuscular ventral hernia repair, Laparoscopic retromuscular ventral hernia repair, Robotic-assisted retromuscular ventral hernia repair
- Where
- 4 sites in United States
- Volunteers
- 74 people
- Sponsor
- Intuitive Surgical
Incisional Hernia, Ventral Hernia
Flexible Composite Next Generation Tissue Separating Mesh in Laparoscopic Incisional/Ventral Hernia Repair
This is a multi-center, observational study of incisional/ventral hernia repair with NG-TSM laparoscopically. The study is not randomized and has a single treatment design assessing NG-TSM intra-operatively, its ease of use and…
- Trial name
- NCT01162564
- Testing
- NG-TSM
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Ethicon, Inc.