Clinical trials: Abdominal Wall Hernia
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
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
Hernia
Assuring and Defining Outcomes Through Procedural Training Using a Proctorship Model That Collects Patient Outcomes A Single-Arm, Case-Series to Determine the Feasibility of Safe Skills Transfer for Laparoscopic Ventral Hernia Repair Utilizing a Hands-On Proctorship Model.
The objective of the Project ADOPT- Ventral Hernia case-series is to collect clinical outcome data following the completion of a hands-on proctorship training model in laparoscopic ventral hernia repair.
- Trial name
- ADOPT (NCT02238743)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Medtronic - MITG
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
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
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
Hernia
A Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation
This will be an observational study designed to collect early, short- and long-term clinical outcomes of the XenMatrix™ Surgical Graft for complex ventral hernia repair.
- Trial name
- XenMatrix (NCT01305486)
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- C. R. Bard
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
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
Hernia, Inguinal, Flat Foot
The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population
Randomized, multi-center, double-blind, two-armed, parallel active groups, prospective trial to evaluate the efficacy and safety of local anesthetic Chloroprocaine at two different concentrations ( at 1% and 2%) in a pediatric…
- Trial name
- NCT03918798
- Testing
- Chloroprocaine 1% Injectable Solution, Chloroprocaine 2% Injectable Solution
- Where
- 9 sites in Italy, Spain
- Volunteers
- 164 people
- Sponsor
- Sintetica SA
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
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)
Hernia, Hernia, Ventral
Transorb™ Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral Hernia
The purpose of RECOVER is to evaluate the performance and safety of Transorb™ self-gripping resorbable mesh in high-risk subjects (at least one risk factor impairing wound healing) when used for reinforcement of abdominal wall…
- Conditions
- Hernia, Hernia, Ventral, Hernia, Abdominal, Hernia Abdominal Wall
- Trial name
- RECOVER (NCT06449378)
- Testing
- Transorb™ Self-Gripping Resorbable Mesh
- Where
- 13 sites in United States, Belgium and 1 more
- Volunteers
- 163 people
- Sponsor
- Medtronic - MITG
Anastomosis, Surgical, Internal Hernia
MagDI U.S. Registry
Assess the incidence and severity of internal hernia and bowel obstruction at one year in a U.S. population following use of the MagDI System to create side-to-side duodeno-ileal anastomoses.
- Conditions
- Anastomosis, Surgical, Internal Hernia, Bowel Obstruction
- Trial name
- NCT06928545
- Testing
- Side-to-side duodenal-ileal anastomosis
- Where
- 6 sites in United States
- Volunteers
- 106 people
- Sponsor
- GT Metabolic Solutions, Inc.
Hernia, Ventral, Hernia, Hiatal
GORE® ENFORM Biomaterial Product Study
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair).
- Conditions
- Hernia, Ventral, Hernia, Hiatal, Hernia, Diaphragmatic, Incisional Hernia
- Trial name
- ENF 18-06 (NCT04718168)
- Testing
- Gore ENFORM Biomaterial (Preperitoneal), Gore ENFORM Biomaterial (Intraperitoneal)
- Where
- 9 sites in United States
- Volunteers
- 245 people
- Sponsor
- W.L.Gore & Associates
Hernia
A Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite
This study will enroll subjects who underwent a laparoscopic ventral hernia repair utilizing Sepramesh at least 12 months before starting in this study.
- Trial name
- Sepramesh (NCT01305473)
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- C. R. Bard
Inguinal Hernia
Phase I/II Dose-escalation Study to Evaluate Safety, PK and Efficacy of TLC590 for Postsurgical Pain Management
Phase I/II, randomized, double-blind, comparator-controlled, dose-escalation study to assess the safety, PK, and efficacy of single postsurgical application of TLC590 compared with Naropin®
- Trial name
- NCT03591146
- Testing
- TLC590, Naropin
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Taiwan Liposome Company
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