Clinical trials: Hernia, Inguinal
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
PMCF Study of LiquiBand FIX8® OHMF Device
Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.
- Trial name
- LBF8-Open (NCT04059640)
- Testing
- LiquiBand FIX8 Open Hernia Mesh Fixation Device
- Where
- 3 sites in United Kingdom
- Volunteers
- 109 people
- Sponsor
- Advanced Medical Solutions Ltd.
Hernia, Ventral, Hernia, Inguinal
Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh
This study is designed to evaluate the post-operative complications and hernia recurrence following the use of OviTex in subjects with ventral or inguinal hernias.
- Trial name
- BRAVOII (NCT04779918)
- Testing
- OviTex Reinforced Tissue Matrix
- Where
- 10 sites in United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Tela Bio Inc
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
Hernia, Inguinal
Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Compared to the Combined Therapy With Spermatic Cord Block
This is a single center randomized, controlled, double-blinded, noninferiority study. Male pediatric patients who underwent inguinal herniotomy will be screened for eligibility.
- Trial name
- NCT05600296
- Testing
- Levobupivacaine, Ilioinguinal/iliohypogastric nerve block (IINB), IINB+ Spermatic cord block
- Where
- Egypt
- Volunteers
- 46 people
- Sponsor
- Egymedicalpedia
Inguinal Hernia
Clinical Performance of HISTOACRYL® LAPFIX - CANNULA for Laparoscopic Inguinal Hernia Repair
The goal of this retrospective study is to identify the incidence of hernia recurrence following the application of Histoacryl® Lapfix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery.
- Trial name
- HISTOLAP (NCT06298500)
- Testing
- hernia repair surgery
- Where
- Spain
- Volunteers
- 443 people
- Sponsor
- Aesculap AG
Inguinal Hernia, Femoral Hernia
Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap)
The purpose of this study is to evaluate the safety and performance of the 4DMESH® used in (robot-assisted) laparoscopic inguinal and femoral hernia repair.
- Trial name
- NCT05306496
- Testing
- Pre-shaped 4DMESH®
- Where
- 9 sites in Belgium, France and 1 more
- Volunteers
- 196 people
- Sponsor
- Cousin Biotech
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
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, 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, Ventral Hernia
Post Market Clinical Follow Up Study for ReliaTack™ Articulating Reloadable Fixation Device With Deep Purchase Tacks
A post-market clinical follow-up study for ReliaTack™ articulating reloadable fixation device with deep purchase tacks
- Trial name
- RAFDT (NCT03526341)
- Testing
- ReliaTack™ Articulating Reloadable Fixation Device
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- Medtronic - MITG
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
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
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
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
Thymoma, Mediastinal Tumor
Clinical Investigation of the da Vinci Surgical System
This prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures.
- Conditions
- Thymoma, Mediastinal Tumor, Gynecologic Disease, Gynecologic Cancer
- Trial name
- NCT05682742
- Testing
- Robotic-assisted Surgery
- Where
- 4 sites in United States
- Volunteers
- 53 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
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
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.
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