Clinical trials: Hernia, Inguinal
Hernia, Inguinal
Safety and Performance of the OTTAVA System in Participants Undergoing Inguinal Hernia Repair
The purpose of this study is to assess safety and performance of the OTTAVA System, through 30 days postoperative, in participants undergoing robotic-assisted inguinal hernia repair (IHR).
- Trial name
- TEMPO (NCT07298317)
- Testing
- OTTAVA Robotic System
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Auris Health, Inc.
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
Hernia, Inguinal, Hernia, Ventral
A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using da Vinci 5 Robot
The goal of this observational study is to understand the utility of force feedback instruments in surgeries that are done using the da Vinci 5 robot.
- Conditions
- Hernia, Inguinal, Hernia, Ventral, Colorectal, Thoracic
- Trial name
- NCT06879912
- Where
- 6 sites in United States
- Volunteers
- 200 people
- Sponsor
- Intuitive Surgical
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
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
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
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
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
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, 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
Hernia, Inguinal, Flat Foot
The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population
Randomized, multi-center, double-blind, two-armed, parallel active groups, prospective trial to evaluate the efficacy and safety of local anesthetic Chloroprocaine at two different concentrations ( at 1% and 2%) in a pediatric…
- Trial name
- NCT03918798
- Testing
- Chloroprocaine 1% Injectable Solution, Chloroprocaine 2% Injectable Solution
- Where
- 9 sites in Italy, Spain
- Volunteers
- 164 people
- Sponsor
- Sintetica SA
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
Postoperative Pain
Phase 2 Herniorrhaphy Study for Opioid Elimination
This is a Phase 2, open-label study in subjects undergoing unilateral open inguinal herniorrhaphy.
- Trial name
- NCT03695367
- Testing
- HTX-011, Luer lock applicator, Vial access device
- Where
- 5 sites in United States
- Volunteers
- 63 people
- Sponsor
- Heron Therapeutics
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
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.
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
Antalgic Efficacy of CycloMesh™ Soaked in Ropivacaine Hydrochloride in Uncomplicated Inguinal Hernia.
CycloMesh is a polyester visceral implant functionalized by drug delivery systems directly on its surface, targeting a unique intervention, a slow anesthetic release and an in situ activity.
- Trial name
- HENRI (NCT04033055)
- Testing
- Inguinal hernia repair with CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mL, Inguinal hernia repair with CycloMesh™ soaked in saline solution NaCl 9°/°°
- Where
- France
- Volunteers
- 304 people
- Sponsor
- Quanta Medical
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
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
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