Clinical trials: Paediatric Surgery
Surgery
Non-Interventional (Observational) Post-Authorization Safety Study of HES 130/0.42 in Paediatric Patients
This observational (non-interventional) post-authorization safety study (PASS) will investigate the application of Venofundin 6% and of Tetraspan 6% in children with special regard to drug safety.
- Trial name
- NCT00806533
- Testing
- HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)
- Where
- 10 sites in Austria, Czechia and 3 more
- Volunteers
- 1,130 people
- Sponsor
- B. Braun Melsungen AG
Efficacy and Safety of Mivacurium Chloride for Pediatric Patients
A Prospective, Multi-center, Randomized Controlled Study of Muscle Relaxation Effect and Safety of Mivacurium Chloride in Pediatric Surgery Patients
To evaluate the effect and safety of mivacurium chloride in pediatric patients.
- Trial name
- NCT02117401
- Testing
- mivacurium chloride, midazolam, ketamine
- Volunteers
- 1,152 people
- Sponsor
- Jiangsu Nhwa Pharmaceutical Co., Ltd.
HLHS
Lomecel-B Delivered During Stage II Surgery for Hypoplastic Left Heart Syndrome (ELPIS)
This study is designed to assess the safety, tolerability, and efficacy of Lomecel-B as an adjunct therapy to the standard stage II (BDCPA) surgical intervention for HLHS. Lomecel-B will be delivered via intramyocardial injections
- Trial name
- ELPIS (NCT03525418)
- Testing
- Longeveron Mesenchymal Stem Cells
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Longeveron Inc.
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
iotaSOFT Pediatric Study
Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Unilateral
- Trial name
- NCT06106373
- Testing
- iotaSOFT Insertion System
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- iotaMotion, Inc.
Cardiac Surgery, Cardiopulmonary Bypass
Voluven® in Paediatric Patients
This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during elective open-heart surgery in pediatric patients.
- Trial name
- NCT00860405
- Testing
- HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L), Human serum albumin (HSA 50g/L)
- Where
- 2 sites in Austria, Belgium
- Volunteers
- 61 people
- Sponsor
- Fresenius Kabi
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of activated recombinant human factor VII and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary…
- Trial name
- NCT01562574
- Testing
- activated recombinant human factor VII
- Where
- Australia
- Volunteers
- 82 people
- Sponsor
- Novo Nordisk A/S
Indications for Laparoscopic Thoracic and Abdominal Surgery in Children, Congenital or Acquired Surgical Conditions Requiring Minimally Invasive Surgery in Children
Clinical Trial on Safety and Efficacy of Thoracoabdominal Endoscopic Surgical System for Pediatric Surgery
This is a prospective, multi-center, single-arm, target-value clinical trial conducted to evaluate the safety and effectiveness of the Thoracic and Abdominal Endoscopic Surgery System (model WJ-SR01-200) in pediatric surgical…
- Conditions
- Indications for Laparoscopic Thoracic and Abdominal Surgery in Children, Congenital or Acquired Surgical Conditions Requiring Minimally Invasive Surgery in Children, Pyeloplasty, Ureteral Reimplantation
- Trial name
- NCT07530133
- Testing
- Thoracic and Abdominal Endoscopic Surgery System
- Where
- 3 sites in China
- Volunteers
- 64 people
- Sponsor
- Hangzhou Kangji Weijing Medical Robotics Co., Ltd.
Pediatric Central Nervous System Tumor
Study of Tozuleristide and the Canvas Imaging System in Pediatric Subjects With CNS Tumors Undergoing Surgery
Many types of cancer are primarily treated with surgery and patient survival is directly related to the extent to which the tumor is able to be removed.
- Trial name
- NCT03579602
- Testing
- tozuleristide, Canvas System
- Where
- 9 sites in United States
- Volunteers
- 118 people
- Sponsor
- Blaze Bioscience Inc.
Hemorrhage, Soft Tissue Bleeding
The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study
To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to achieve haemostasis during surgery in paediatric patients.
- Trial name
- NCT02227706
- Testing
- EVICEL® Fibrin Sealant, SURGICEL® Absorbable Hemostat
- Where
- 13 sites in Belgium, Canada and 1 more
- Volunteers
- 40 people
- Sponsor
- Ethicon, Inc.
Hemorrhage, Soft Tissue Bleeding
The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft tissue \& parenchymal bleeding during open…
- Conditions
- Hemorrhage, Soft Tissue Bleeding, Hepatic Parenchyma Bleeding
- Trial name
- NCT02227992
- Testing
- EVARREST™ Sealant Matrix, SURGICEL®
- Where
- 10 sites in Belgium, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Ethicon, Inc.
Robotic Surgical Procedures in Pediatric Urology
Versius Paediatrics Study
This is prospective, multi-phase, single arm, multi-centre, multi-surgeon feasibility clinical trial to provide proof of concept and clinical evidence regarding the safety and efficacy of Versius (robotic surgery medical device)…
- Trial name
- NCT06539442
- Testing
- Versius Surgical System
- Where
- 3 sites in United Kingdom
- Volunteers
- 150 people
- Sponsor
- CMR Surgical Ltd
Laceration
A Randomized Post-market Study to Evaluate Zip Device Compared to Sutures for Laceration Repair in Pediatrics and Adults
The Zip-009 clinical investigation will enroll 26 paediatric and adult subjects requiring laceration repair and fulfilling the eligibility criteria for the clinical investigation.
- Trial name
- NCT03199456
- Testing
- Zip surgical skin closure device, Standard of Care sutures
- Where
- 2 sites in Sweden
- Volunteers
- 26 people
- Sponsor
- ZipLine Medical Inc.
Congenital Fibrinogen Deficiency
Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin in Paediatric Subjects With Fibrinogen Deficiency
This study will assess the efficacy of Octafibrin, a fibrinogen concentrate in in the on-demand treatment of spontaneous or traumatic bleeding episodes in paediatric patients less than 12 years of age.The planned study duration…
- Trial name
- NCT02408484
- Testing
- Octafibrin
- Where
- 4 sites in India, Iran and 1 more
- Volunteers
- 15 people
- Sponsor
- Octapharma
Laceration of Skin
Evaluation of Zip Device to Conventional Sutures for Laceration Repair in Pediatrics in an Emergency Department
A prospective, randomized, controlled post-market clinical investigation that will enroll pediatric subjects requiring laceration repair.
- Trial name
- ZIPPED (NCT04122859)
- Testing
- Zip Skin Closure Device
- Where
- Israel
- Volunteers
- 30 people
- Sponsor
- ZipLine Medical Inc.
Excessive Bleeding During Surgery
A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants
The objective of the study is to evaluate if FS Grifols is non-inferior to EVICEL® in terms of the percentage of participants achieving hemostasis at the target bleeding site (TBS) by 4 minutes (T4) from the start of treatment…
- Trial name
- NCT03461406
- Testing
- Fibrin Sealant Grifols, EVICEL
- Where
- 40 sites in United States, Bulgaria and 8 more
- Volunteers
- 186 people
- Sponsor
- Instituto Grifols, S.A.
Liver Diseases
TachoSil Paediatric Liver Trial (TC-019-IN)
The overall objective is to assess the haemostatic efficacy and safety of TachoSil for control of local bleeding in paediatric patients undergoing surgical resection of the liver with our without segmental liver transplantation.
- Trial name
- NCT00365248
- Testing
- Fibrinogen human (TachoSil)
- Where
- Denmark
- Volunteers
- 16 people
- Sponsor
- Nycomed
Acute Lung Injury
L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects
The purpose of this study is to determine whether L-citrulline is effective and safe in the prevention of clinical sequelae of Acute Lung Injury in pediatric subjects undergoing surgery for congenital heart defects.
- Trial name
- NCT02891837
- Testing
- L-citrulline
- Where
- 29 sites in United States, Austria and 2 more
- Volunteers
- 189 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Surgery, Surgery in Early Childhood
The Asensus Paediatric Robotic Registry
An open-label, observational, paediatric registry trial in which participating centers enroll subjects who had or will have a laparoscopically-assisted surgery using the Senhance Surgical System.
- Trial name
- miniTRUST (NCT07081828)
- Testing
- Surgery
- Where
- Germany
- Volunteers
- 37 people
- Sponsor
- Asensus Surgical
Pediatric Perioperative Blood Pressure Management
Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Participants Undergoing Surgery (PIONEER)
Evaluate the efficacy, safety, and dosing of clevidipine as an intravenous (IV) infusion for blood pressure (BP) management in paediatric participants in the perioperative setting.
- Trial name
- PIONEER (NCT01938547)
- Testing
- clevidipine
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Surgery, Pediatric Surgery
Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline
Because pain is difficult to measure in children, post-operative pain is frequently undertreated in this age range. Pain treatment is required in children due to the high emotional component of pain.
- Trial name
- NCT05444036
- Testing
- Ketamine
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Egymedicalpedia