Clinical trials: Herniorrhaphies
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
Hernia Repair, Hernia Inguinal
Postsurgical Analgesia After Hernia Repair
The study is designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of three ascending doses of AMT-143 to determine the appropriate dose of AMT-143 for the management of postsurgical pain following inguinal hernia…
- Conditions
- Hernia Repair, Hernia Inguinal, Hernia Surgery, Hernia, Inguinal/Surgery
- Trial name
- NCT06709612
- Testing
- AMT-143, ropivacaine
- Sponsor
- AmacaThera Inc.
Inguinal Hernia
Safety and Performance Study of TIGR Matrix Surgical Mesh in Inguinal Hernia Repair
This an open, uncontrolled multicenter clinical study to assess the safety and performance of the WK-6 surgical mesh in adult patients with unilateral inguinal hernia.
- Trial name
- NCT01193985
- Testing
- TIGR Matrix Surgical Mesh
- Where
- 2 sites in Sweden
- Volunteers
- 40 people
- Sponsor
- Novus Scientific
Inguinal Hernia
Pain and Quality of Life After Inguinal Hernia Repair
This study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted inguinal hernia repair.
- Trial name
- PREPARE (NCT04074200)
- Testing
- Open Inguinal Hernia Repair, Laparoscopic Inguinal Hernia Repair, Robotic-Assisted Inguinal Hernia Repair
- Where
- United States
- Volunteers
- 156 people
- Sponsor
- Intuitive Surgical
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
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
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
Hernia
TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study
The purpose of this study is to capture preliminary clinical safety and performance on the TAHRS
- Trial name
- NCT06042205
- Testing
- TISSIUM™ Atraumatic Hernia Repair System (TAHRS)
- Where
- 5 sites in Belgium, Spain
- Volunteers
- 78 people
- Sponsor
- Tissium
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
Hernioplasty
Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant
Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy hernioplasty and assess the relative bioavailability of Xaracoll compared to a local bupivacaine infiltration.
- Trial name
- NCT02232178
- Testing
- 2 100mg Xaracoll implants, 3 100mg Xaracoll implants, 150mg Bupivacaine HCl injection
- Where
- 5 sites in United States
- Volunteers
- 64 people
- Sponsor
- Innocoll
Postoperative Urinary Retention
Preoperative Administration of Tamsulosin for Prevention of Post Operative Urinary Retention in Males Undergoing Elective Inguinal Hernia Repair
Double blinded, randomized controlled prospective study looking at 2 preoperative doses of Tamsulosin an alpha-adrenergic blocker in preventing post-operative urinary retention.
- Trial name
- NCT02958878
- Testing
- Tamsulosin
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Ascension Health
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
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
Comparison of Patient Perceived Pain and Satisfaction Between Lightweight and Heavyweight Mesh for Laparoscopic Inguinal Hernia Repair
This study will be comparing the patients overall satisfaction of two different meshes used in laparoscopic inguinal hernia repairs.
- Trial name
- NCT01638221
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Ascension Health
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
Pain, Postoperative
Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty
This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled efficacy and safety study of postoperative pain in adults who are scheduled for unilateral inguinal hernioplasty via open laparotomy…
- Trial name
- MATRIX-2 (NCT02525133)
- Testing
- XaraColl
- Where
- 24 sites in United States
- Volunteers
- 319 people
- Sponsor
- Innocoll
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
Post Abdominal Surgery Pain
A Study Evaluating the Overall Pain Relief and Safety of Intravenous (IV) CR845 in Patients Undergoing Abdominal Surgery
The study schedule is comprised of a 14-day Screening Period, a treatment period and an observation period. All eligible subjects will be randomized into one of 3 treatment groups (1 of 2 dose levels or matched placebo).
- Trial name
- NCT02542384
- Testing
- CR845 IV 1 mcg/kg, CR845 IV 0.5 mcg/kg
- Where
- 23 sites in United States
- Volunteers
- 451 people
- Sponsor
- Cara Therapeutics, Inc.
Hernia
Large Abdominal Hernia Repair With SurgiMend 3.0
The rate of hernia recurrence at one year following repair of a large abdominal hernia with a biologic mesh is high, ranging from 30% to 100%, with a reported historic average rate of 40%.
- Trial name
- BRIDGE (NCT00892333)
- Where
- 8 sites in United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Integra LifeSciences Corporation
Inguinal Herniorrhaphy
A Phase 2, Randomized, Double-Blind, Dose Escalation Study in Postoperative Pain Open Inguinal Herniorrhaphy
This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing open inguinal herniorrhaphy with mesh.
- Trial name
- NCT05080959
- Testing
- CPL-01, Naropin 150 MG Per 20 ML Injection
- Where
- 5 sites in United States
- Volunteers
- 105 people
- Sponsor
- Cali Pharmaceuticals LLC