Clinical trials: Inguinal Hernia Repair
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
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
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
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
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
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
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
Postoperative Pain
Pilot Herniorrhaphy Study for Postoperative Analgesia
A Phase 2, Randomized, Pilot Study to Investigate the Safety, Efficacy, Pharmacokinetics and Bioavailability of HTX-011, HTX-002, or HTX-009 Administered Via Injection and/or Topical Application Following Unilateral Open Inguinal…
- Trial name
- NCT02504580
- Testing
- HTX-011, HTX-002, Bupivacaine HCI (Marcaine)
- Where
- 3 sites in United States
- Volunteers
- 463 people
- Sponsor
- Heron Therapeutics
Inguinal Hernia, Postoperative Pain
Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair
A multicenter, single-dose study in children 12 to <17 years of age, 6 to <12 years of age, and 2 to <6 years of age who are scheduled for elective open inguinal hernia repair.
- Trial name
- NCT03262688
- Testing
- Bupivacaine HCl collagen-matrix implant, Bupivacaine HCl infiltration
- Where
- 11 sites in United States
- Volunteers
- 159 people
- Sponsor
- Innocoll
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
Inguinal Hernia
A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair
This investigation will be a double-armed, randomized (Blinded patients and Blinded examiner) prospective study designed to collect perioperative and postoperative data to compare the QOL of ProFlor vs.
- Trial name
- NCT02240550
- Testing
- ProFlor Hernia Repair System, Lichtenstein hernia repair
- Where
- India
- Volunteers
- 50 people
- Sponsor
- Insightra Medical, Inc.
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
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
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.
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
Postoperative Pain
Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in…
- Trial name
- NCT03237481
- Testing
- HTX-011, Bupivacaine HCl, Luer-lock applicator
- Where
- 24 sites in United States, Belgium
- Volunteers
- 418 people
- Sponsor
- Heron Therapeutics