Clinical trials: Surgery in Children
- Condition Surgery in Children
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Congenital Heart Malformations
Study of Cardioplegia in Cardiac Surgery Due to Congenital Heart Malformation in Children
The objective of this investigation is to compare the safety and cardioprotective effects of Custodiol and Custodiol-N in children undergoing cardiac surgery with cardiopulmonary bypass (CPB) due to congenital heart malformation.
- Trial name
- NCT07381530
- Testing
- heart will be treated with Custodiol-N, heart will be treated with Custodiol
- Where
- 3 sites in Germany
- Volunteers
- 100 people
- Sponsor
- Dr. F. Köhler Chemie GmbH
Postoperative Pain, Acute Pain
Pharmacokinetic, Efficacy and Safety Study of Tapentadol Oral Solution in Children With Postoperative Pain
To find out if a drug called tapentadol administered by mouth safely relieves pain in children. Look at the amount of tapentadol in the blood after a single oral dose.
- Trial name
- NCT01729728
- Testing
- Tapentadol
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- Grünenthal GmbH
Cataract
Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.
The objective of this study is to compare the efficacy and safety for the treatment of postoperative inflammation following ocular surgery for childhood cataract.
- Trial name
- NCT01475643
- Testing
- Loteprednol etabonate, Prednisolones acetate
- Where
- United States
- Volunteers
- 107 people
- Sponsor
- Bausch & Lomb Incorporated
Surgery
Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children
The study will collect cerebral oximetry data from pediatric and neonatal subjects using the Masimo O3 regional oximetry device, for the purposes of device calibration and validation.
- Trial name
- NCT03123354
- Testing
- O3 regional oximeter sensor
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Masimo Corporation
Achondroplasia
A Clinical Trial to Evaluate Safety of Vosoritide in At-risk Infants With Achondroplasia
Study 111-209 is a Phase 2 randomized, open-label clinical trial of BMN 111 in infants and young children with a diagnosis of Achondroplasia at a heightened risk of requiring cervicomedullary decompression surgery
- Trial name
- NCT04554940
- Testing
- vosoritide
- Where
- 3 sites in Australia, United Kingdom
- Volunteers
- 20 people
- Sponsor
- BioMarin Pharmaceutical
Limb Length Discrepancy
A Review of Precice Intramedullary Limb Lengthening (IMLL) System for Limb Lengthening Procedures in Children.
This study will look at how safe and effective limb lengthening surgeries are for the femur and tibia in children 12 years old and younger.
- Trial name
- NCT06714110
- Testing
- Intramedullary Limb Lengthening Device, External Fixator Limb Lengthening Device
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- NuVasive
Cataract in Child
FLACS in Pediatric Patients Using FEMTO LDV-Z8
This study is a single center prospective observational case series. The framework of this clinical investigation is post market clinical follow up of pediatric FLACS using the Femto LDV Z8.
- Trial name
- NCT05241756
- Testing
- FLACS using FEMTO LDV-Z8
- Where
- Belgium
- Volunteers
- 12 people
- Sponsor
- Ziemer Ophthalmic Systems AG
Pain, Postoperative
Study of Indomethacin Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age
The purposes of this study are to evaluate the safety and tolerability and to model the single-dose pharmacokinetic profile of indomethacin capsules low dose and high dose in children ages 6 to <17 years experiencing mild to…
- Trial name
- NCT02633969
- Testing
- Indomethacin Capsules low dose, Indomethacin Capsules high dose
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Iroko Pharmaceuticals, LLC
Post Cardiac Surgery
Measure Cardiac Output Using Ultrasound Dilution in Mechanically Ventilated Children
The measurement of cardiac output (CO) and hemodynamic pressures are vital for proper management of severely hemodynamic compromised patients.
- Trial name
- NCT01662141
- Where
- Sweden
- Volunteers
- 33 people
- Sponsor
- Transonic Systems Inc.
Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage
HEMOLEVEN® Expanded Access Program Prevention of Surgical/Postpartum Hemorrhage Severe Inherited Factor XI Deficiency
The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of…
- Conditions
- Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage, Surgery
- Trial name
- EAP (NCT01701947)
- Testing
- Hemoleven
- Where
- United States
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Otitis Media With Effusion in Children, Otitis Media Recurrent
Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)
The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects, immediately after bilateral tympanostomy tube surgery.
- Trial name
- NCT02539654
- Testing
- EXE844 Sterile Otic Suspension, 0.3%, Tympanostomy Tube Insertion
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Alcon Research
Analgesia
Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures
This is a prospective non-randomized, open-label, single dose (and a second dose if needed), PK study in 25 children age 1-17 years.
- Trial name
- NCT04897750
- Testing
- CT001
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Cessatech 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.
Moderate to Severe Acute Postoperative Pain
Use of Tapentadol Oral Solution for Pain After Surgery in Children From Newborn to Less Than 2 Years Old
This is a multicenter, open-label (all people involved know the identity of the intervention), single dose trial to evaluate the pharmacokinetic (PK) profile (how drugs are absorbed in the body, how are they distributed within…
- Trial name
- NCT02221674
- Testing
- Tapentadol
- Where
- 7 sites in United States, Poland and 1 more
- Volunteers
- 40 people
- Sponsor
- Grünenthal GmbH
Prevention of Venous Thromboembolism, Congenital Heart Disease
An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure
This is an observational study in which the data from children with congenital heart disease will be collected and studied. These children will include those who are prescribed rivaroxaban by their doctors after a heart surgery…
- Conditions
- Prevention of Venous Thromboembolism, Congenital Heart Disease, Fontan Procedure, Children
- Trial name
- NCT06193863
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- Japan
- Volunteers
- 61 people
- Sponsor
- Bayer
Hearing Loss, Conductive, Hearing Loss, Mixed
Evaluating the Safety of BONEBRIDGE Implants in Children Under Five Years Old: This Study Looks at Children Under Five Who Got BONEBRIDGE BCI 602 Implants. It Collects Information on Any Problems With the Device or the Surgery to See if it is Safe Within the First Year After the Operation.
This study, titled "The BONEBRIDGE in Children Under Five: Premarket Clinical Investigation" (Study ID 2023BB006), looks at kids under five who have received the BONEBRIDGE BCI 602 hearing implant.
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed, Children Under 5 Years
- Trial name
- 2023BB006 (NCT06634784)
- Testing
- Bone Conduction Implant (BCI)
- Where
- 2 sites in Germany
- Volunteers
- 9 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
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
Sedation
A Study to Learn About the Study Medicine - Precedex in Children From Japan.
The purpose of this study is to look at the safety of Precedex when it was used to calm children at procedures or tests under actual medical practice in Japan.
- Trial name
- NCT06085573
- Testing
- Dexmedetomidine Hydrochloride
- Where
- Japan
- Volunteers
- 111 people
- Sponsor
- Pfizer
Ocular Inflammation
KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children
This study is designed to assess how KPI-121 1% compares to prednisolone acetate in reducing inflammation after cataract surgery in young children.
- Trial name
- NCT03596723
- Testing
- KPI-121 1%, Prednisolone acetate
- Where
- 4 sites in United States
- Volunteers
- 2 people
- Sponsor
- Kala Pharmaceuticals, Inc.
Atrial Septal Defect, Ventricular Septal Defect
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery.
- Conditions
- Atrial Septal Defect, Ventricular Septal Defect, Atrioventricular Septal Defect
- Trial name
- NCT01120964
- Testing
- Intravenous L-Citrulline
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Asklepion Pharmaceuticals, LLC