Clinical trials: Herniorrhaphy
Ventral Hernia
Hernia Repair in Multiply Morbid Patients
Support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in a diminished rate of hernia recurrence.
- Trial name
- RAM2P (NCT00930787)
- Testing
- Strattice Reconstructive Tissue Matrix (Hernia Repair), Proceed Surgical Mesh (Hernia repair)
- Where
- 13 sites in United States
- Volunteers
- 23 people
- Sponsor
- LifeCell
Ventral Hernia
Tacks Versus Glue for Mesh Fixation in Laparoscopic Ventral Hernia Repair Treating Defects Between 2 and 5 cm Width
In laparoscopic ventral hernia repair, an abundance of methods has been developed to fix the mesh to the abdominal wall, including sutures (non-absorbable or absorbable), staples (non-absorbable or absorbable), clips, tacks…
- Trial name
- NCT03429374
- Testing
- Liquiband Fix8, Absorbable tack
- Where
- 11 sites in Belgium
- Volunteers
- 16 people
- Sponsor
- Duomed
Hernia, Ventral, Incisional Hernia
A Prospective Trial of a Bio-absorbable Mesh in Challenging Laparoscopic Ventral or Incisional Hernia Repair
The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ ST in subjects receiving laparoscopic ventral or incisional hernia repair at high risk for surgical site occurrence…
- Trial name
- ATLAS (NCT02712398)
- Testing
- Phasix™ ST
- Where
- 16 sites in United States
- Volunteers
- 120 people
- Sponsor
- C. R. Bard
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 Repair
A Trial of HR18034 in Inguinal Hernia Repair
Phase I, randomized, double-blind, comparator-controlled study to assess the safety, PK, and efficacy of single postsurgical application of HR18034 compared with Naropin®
- Trial name
- NCT04551924
- Testing
- HR18034, Naropin
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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
Hernia, Ventral, Hernia Incisional
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
The SYN 20-01 Study is a non-interventional, prospective, multicenter, multicohort, international, post-market clinical investigation looking into the assessment of GORE® SYNECOR Biomaterial in focused patient populations and in…
- Conditions
- Hernia, Ventral, Hernia Incisional, Hernia Incisional Ventral
- Trial name
- SYN 20-01 (NCT05094089)
- Testing
- Hernia repair with mesh
- Where
- 15 sites in United States, Italy and 2 more
- Volunteers
- 320 people
- Sponsor
- W.L.Gore & Associates
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
Incisional Hernia, Ventral Hernia
Flexible Composite Next Generation Tissue Separating Mesh in Laparoscopic Incisional/Ventral Hernia Repair
This is a multi-center, observational study of incisional/ventral hernia repair with NG-TSM laparoscopically. The study is not randomized and has a single treatment design assessing NG-TSM intra-operatively, its ease of use and…
- Trial name
- NCT01162564
- Testing
- NG-TSM
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Ethicon, Inc.
Inguinal Hernia
Phase I/II Dose-escalation Study to Evaluate Safety, PK and Efficacy of TLC590 for Postsurgical Pain Management
Phase I/II, randomized, double-blind, comparator-controlled, dose-escalation study to assess the safety, PK, and efficacy of single postsurgical application of TLC590 compared with Naropin®
- Trial name
- NCT03591146
- Testing
- TLC590, Naropin
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Taiwan Liposome Company
Hernia
AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE
The primary purpose of this clinical trial is to assess the safety and performance of the ECLIPSIUM device in securing mesh during ventral hernia repair.
- Trial name
- UNITE (NCT07277946)
- Testing
- ECLIPSIUM® System, Resorbable tacks (AbsorbaTack/SorbaFix)
- Where
- 12 sites in United States
- Volunteers
- 240 people
- Sponsor
- Tissium
Hernia Incisional Ventral
LIQUIBAND FIX8® for Ventral Incisional Hernia
This study is designed to evaluate the safety and performance of device LiquiBand FIX8 Open hernia mesh fixation device. The use of this device is not experimental, as it is already approved for use in the EU (CE-marked).
- Trial name
- LBF8-03 (NCT07295379)
- Testing
- LIQUIBAND FIX8
- Where
- United Kingdom
- Volunteers
- 148 people
- Sponsor
- Advanced Medical Solutions Ltd.
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
Ventral Hernia
Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1
The purpose of the registry is to evaluate safety and efficacy of the Intramesh T1. This registry will collect data from 100 patients treated for a ventral hernia repair.
- Trial name
- NCT01816867
- Testing
- Intramesh T1 implantation
- Where
- Belgium
- Volunteers
- 96 people
- Sponsor
- be Medical
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
Postoperative Pain, Hernia
A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair
This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local…
- Conditions
- Postoperative Pain, Hernia, Surgery
- Trial name
- NCT00974350
- Testing
- SABER-Bupivacaine
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 124 people
- Sponsor
- Durect
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
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
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 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