Clinical trials: Inguinal Herniorrhaphy
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
Primary Inguinal Hernia
Freedom Inguinal Hernia Repair System Study
The primary objective of this study is to evaluate patient quality-of-life (QOL) after inguinal hernia repair. "Carolinas Comfort Scale" (CCS) assessments will be held at regular intervals.
- Trial name
- NCT01984996
- Testing
- Freedom ProFlor Inguinal Hernia Implant
- Where
- 8 sites in United States, Austria and 1 more
- Volunteers
- 100 people
- Sponsor
- Insightra Medical, Inc.
Hernia, Inguinal
Comparative Study of Safety and Efficacy of Heavyweight and Partially Absorbable Mesh in Inguinal Hernia Repair
Proflex® Mesh (partially absorbable mesh, Korea) and Marlex® Mesh (heavyweight mesh) will be used for inguinal hernia repair to compare the safety and efficacy (pain score, quality of life)of two devices at 3 months follow-up.
- Trial name
- NCT01877122
- Testing
- Proflex® Mesh Mesh implantation, Marlex® Mesh Implant
- Where
- South Korea
- Volunteers
- 50 people
- Sponsor
- Samyang Biopharmaceuticals Corporation
Hernia, Inguinal, Post Operative Pain
Herniorrhaphy for Postoperative Pain
Subjects receive either CPL-01, positive control, or negative control after herniorrhaphy and are then followed.
- Trial name
- NCT05813847
- Testing
- local anaesthetic injection of CPL-01, Morphine (rescue medication), Acetaminophen (rescue medication)
- Where
- United States
- Volunteers
- 518 people
- Sponsor
- Cali Pharmaceuticals LLC
Inguinal Hernia, Ventral Hernia
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Hernia Surgery (Enable Hernia Repair)
A prospective, multicenter, single-arm pivotal study will be performed with 192 subjects enrolled to have an inguinal or ventral robotic hernia repair procedure using the Medtronic Hugo™ RAS system.
- Trial name
- NCT06445504
- Testing
- Robotic-Assisted Surgery (RAS) Hernia Repair Surgery
- Where
- 7 sites in United States
- Volunteers
- 206 people
- Sponsor
- Medtronic - MITG
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
Inguinal Hernia Repair, Pain, Postoperative
Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block
Abdominal wall hernias are common, with a prevalence of 1.7% for all ages and 4% for those aged over 45 years. Inguinal hernias account for 75% of abdominal wall hernias, with a lifetime risk of 27% in men and 3% in women.
- Trial name
- NCT05559437
- Testing
- Levo-bupivacaine 0.25
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Egymedicalpedia
Inguinal Hernia
Evaluation of the Safety, Efficacy, and Pharmacokinetics of SKY0402 in Subjects Undergoing Inguinal Hernia Repair
The primary objective of this study was to determine the appropriate dose of SKY0402 for the management of postoperative pain following inguinal hernia repair.
- Trial name
- NCT01203644
- Testing
- SKY0402, Bupivacaine HCl
- Volunteers
- 76 people
- Sponsor
- Pacira Pharmaceuticals, Inc
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
Hernia, Inguinal, Hernia, Ventral
AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair
The objective of this study is to assess pain that occurs following hernia repair that is related to mesh fixation. The study is designed to see if there is any difference in pain after surgery between absorbable and permanent…
- Trial name
- NCT00749268
- Testing
- AbsorbaTack, ProTack
- Where
- 2 sites in United States
- Volunteers
- 216 people
- Sponsor
- Medtronic - MITG
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.
Hernia, Inguinal, Hernia, Inguinal, Direct
Evaluation of Clinical Outcomes in Robotic-Assisted Inguinal Hernia Repair
This multi-center, retrospective data collection study will evaluate the feasibility, safety and performance of the da Vinci® surgical system for patients who have undergone robotic-assisted inguinal hernia repair, as well as…
- Conditions
- Hernia, Inguinal, Hernia, Inguinal, Direct, Hernia, Inguinal, Indirect
- Trial name
- NCT02684448
- Testing
- Inguinal Hernia Repair
- Where
- 2 sites in United States
- Volunteers
- 1,258 people
- Sponsor
- Intuitive Surgical
Hernia, Inguinal
Strattice in Repair of Inguinal Hernias
This is a prospective, randomized, controlled, third-party blinded, multicenter, interventional evaluation of inguinal hernia repair comparing Strattice to light weight polypropylene mesh.
- Trial name
- RING (NCT00681291)
- Testing
- Inguinal hernia repair with Ultrapro, Inguinal hernia repair with Strattice
- Where
- 8 sites in United States
- Volunteers
- 172 people
- Sponsor
- LifeCell
Postoperative Pain, Inguinal Hernia
Efficacy, Safety and Pharmacokinetic Profile of a Collagen Bupivacaine Implant in Men After Open Mesh Herniorrhaphy
The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after herniorrhaphy.
- Trial name
- NCT00626886
- Testing
- Bupivacaine Collagen Sponge
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Innocoll
Inguinal Hernia Repair
Robotic Minimally Invasive Inguinal Hernia Repair With Dexter
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing primary transperitoneal unilateral or bilateral inguinal hernia…
- Trial name
- RAS-Ahead (NCT05873582)
- Testing
- Robotic-assisted inguinal hernia repair
- Where
- 3 sites in France, Germany and 1 more
- Volunteers
- 50 people
- Sponsor
- Distalmotion SA
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 Repair
Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System
The purpose of this post-market, observational study is to collect data under anticipated conditions of use that demonstrates that DEXTER performs as intended in the intended patient population, including a variety of…
- Trial name
- RAS-ACCESS (NCT07181876)
- Testing
- inguinal hernia repair
- Where
- 2 sites in United States
- Volunteers
- 140 people
- Sponsor
- Distalmotion SA
Robotic Assisted Inguinal Hernia Repair
Versius Clinical Study in Robot Assisted Inguinal Hernia Repair Surgery
The objective of this clinical trial is to evaluate the safety and efficacy of Versius in Inguinal Hernia repair surgery
- Trial name
- NCT07316517
- Testing
- Versius Surgical System
- Where
- 2 sites in Italy, Spain
- Volunteers
- 30 people
- Sponsor
- CMR Surgical Ltd
Postsurgical Pain Management
Phase 2/3 Study of TLC590 for Postsurgical Pain Management
A phase 2/3 randomized, double-blind, 2-part, comparator- and placebo-controlled study to assess the safety, pharmacokinetics and efficacy of postsurgical local infiltration in adult subjects following inguinal hernia repair…
- Trial name
- NCT05161637
- Testing
- TLC590, Bupivacain, Ropivacaine
- Volunteers
- 415 people
- Sponsor
- Taiwan Liposome Company
Inguinal Hernia, Pain
SEMPERFLO* Pain Management System in Inguinal Hernia Repair
This study will compare the clinical performance of the SEMPERFLO* Pain Management System with another commercial pain relief system using 0.5% bupivacaine following unilateral, open, inguinal hernia repair procedures. *Trademark
- Trial name
- NCT00423241
- Testing
- SEMPERFLO Pain Management System, ON-Q PainBuster Post-Op Pain Relief System
- Where
- 6 sites in United States
- Volunteers
- 7 people
- Sponsor
- Ethicon, Inc.