Clinical trials: Abdominal Hernia
Hernia, Incisional Hernia
A Prospective Study to Compare the Clinical Outcomes, Pain and Patient Quality of Life for Hernia Patients
The objective of this prospective, multi-center post-market study is to prospectively collect uniform, evidence based outcomes for patients undergoing open, laparoscopic or robotic assisted hernia repair.
- Conditions
- Hernia, Incisional Hernia, Hernia, Inguinal, Indirect, Hernia, Inguinal, Direct
- Trial name
- NCT02715622
- Testing
- Hernia repair
- Where
- 17 sites in United States
- Volunteers
- 944 people
- Sponsor
- Intuitive Surgical
Hernia, Inguinal
Early Surgeon Experience With Robotic-Assisted Inguinal Hernia Repair
The primary objective of this study is to evaluate the progression of surgeon efficiency and proficiency of traditionally open or laparoscopic surgeons performing robotic-assisted inguinal hernia repair throughout their learning…
- Trial name
- NCT04353687
- Testing
- Robotic-assisted inguinal hernia repair
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Intuitive 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
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
Ventral Hernia, Pain
Transfacial Sutures Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair
Hernia of the abdominal wall occur frequently after various surgical procedures of the abdomen and are increasingly performed by laparoscopic means.
- Trial name
- NCT00773851
- Testing
- mesh fixation by transfacial sutures, mesh fixation by staples
- Where
- Switzerland
- Volunteers
- 36 people
- Sponsor
- Medtronic - MITG
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
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
General Laparoscopic Surgeries
Comparison of Laparoscopic Procedures With and Without the Aid of the AutoLap System- a Robotic Camera Holder
The objective of this study is to evaluate the ability to reduce the number of OR personnel required while performing the following procedures: colon resections, cholecystectomies and anti-reflux/hiatal hernia surgery with the…
- Trial name
- NCT02934542
- Testing
- AutoLap system
- Where
- Netherlands
- Volunteers
- 108 people
- Sponsor
- M.S.T. Medical Surgery Technology LTD.
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
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
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
Miromatrix Biological Mesh for Ventral Hernia Repair
This study is being conducted to gather long-term data of the performance of the Miromatrix Biological Mesh.
- Trial name
- MIROMESH PM-1 (NCT02408458)
- Testing
- MIROMESH®
- Where
- 4 sites in United States
- Sponsor
- Miromatrix Medical 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
Ventral Hernia
Tacks Versus Glue for Mesh Fixation in Laparoscopic Ventral Hernia Repair Treating Defects Between 2 and 5 cm Width
In laparoscopic ventral hernia repair, an abundance of methods has been developed to fix the mesh to the abdominal wall, including sutures (non-absorbable or absorbable), staples (non-absorbable or absorbable), clips, tacks…
- Trial name
- NCT03429374
- Testing
- Liquiband Fix8, Absorbable tack
- Where
- 11 sites in Belgium
- Volunteers
- 16 people
- Sponsor
- Duomed
Analgesia
Pediatric Postoperative Analgesia Herniorrhaphy Study
This is a Phase 2 study in pediatric subjects undergoing inguinal herniorrhaphy.
- Trial name
- NCT03922048
- Testing
- HTX-011, Bupivacaine HCl, Luer Lock Applicator
- Sponsor
- Heron Therapeutics
Surgery
Maestro LIFT-OFF: Surgical Assistance Device in Abdominal Laparoscopic Surgery
The objective of the study is to provide evidence for the safety and effectiveness of the Maestro Platform for surgical assistance in abdominal laparoscopic surgery.
- Trial name
- Maestro (NCT05243433)
- Testing
- Laparoscopic surgery using the Maestro Platform
- Where
- Belgium
- Volunteers
- 50 people
- Sponsor
- Moon Surgical
Hernia, Ventral, Hernia Incisional
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
The SYN 20-01 Study is a non-interventional, prospective, multicenter, multicohort, international, post-market clinical investigation looking into the assessment of GORE® SYNECOR Biomaterial in focused patient populations and in…
- Conditions
- Hernia, Ventral, Hernia Incisional, Hernia Incisional Ventral
- Trial name
- SYN 20-01 (NCT05094089)
- Testing
- Hernia repair with mesh
- Where
- 15 sites in United States, Italy and 2 more
- Volunteers
- 320 people
- Sponsor
- W.L.Gore & Associates
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
Hiatal Hernia
Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®
This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.
- Trial name
- ECH2O2 (NCT07070115)
- Testing
- OviTex Reinforced Tissue Matrix
- Where
- 5 sites in United States
- Volunteers
- 173 people
- Sponsor
- Tela Bio Inc
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