Clinical trials: Pediatric Surgery
- Condition Pediatric Surgery
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage
Study to Obtain Volume Effect and Safety Data on 6 % Hydroxyethyl Starch 130/0.4 in Pediatric and Adult Patients Undergoing Major Elective Surgery
The study shall evaluate the volume effect and safety of 6 % hydroxyethyl starch 130/0.4 for restoration and maintenance of hemodynamics during the investigational period in patients undergoing major elective surgery.
- Trial name
- NCT01127477
- Testing
- 1: Hydroxyethyl starch 130/0.4, 6 %
- Where
- 4 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Fresenius Kabi Japan
Pediatric Cancer, Surgery
A Pilot Randomized Controlled Trial for Feasibility of Administering an AR Game to Postoperative Pediatric Cancer Patients
This is a pilot study to evaluate the feasibility of SpellBound's AR (augmented reality)-enabled scavenger hunt use among 20 pediatric cancer patients undergoing surgery.
- Trial name
- GAMING (NCT04674150)
- Testing
- ARISE with AR, ARISE without AR
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- ALTality, 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
Cardiac Surgery, Thoracic Surgery
Heart Lung Machine Registry
The HeaLMe post-market clinical follow-up registry is undertaken to evaluate the safety and performance of the index devices Heart Lung Machine HL 40 and Temperature Probes TPO-D-HLM L1.8 Adult / Pediatric in patients undergoing…
- Conditions
- Cardiac Surgery, Thoracic Surgery, Vascular Surgery, Cardiopulmonary Bypass
- Trial name
- HeaLMe (NCT06159517)
- Where
- 3 sites in Italy, Spain
- Volunteers
- 184 people
- Sponsor
- Maquet Cardiopulmonary 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
Hypovolemia
Safety Study of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients
This is a randomized, controlled, open-label clinical trial aimed to evaluate the Safety of Kedbumin 25% Compared to Normal Saline Solution in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients Undergoing Major…
- Trial name
- NCT01531803
- Testing
- Kedbumin 25%, Normal Saline Solution
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Kedrion S.p.A.
Cataract
A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
To assess the safety of Dextenza compared to an active control, prednisolone acetate suspension, for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract.
- Trial name
- NCT04539548
- Testing
- Dextenza Ophthalmic Insert, Prednisolone acetate ophthalmic suspension USP 1%
- Where
- 14 sites in United States
- Volunteers
- 65 people
- Sponsor
- Ocular Therapeutix, Inc.
Post-Operative Nausea and Vomiting
A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy
This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of Kytril in preventing postoperative nausea and vomiting (PONV) in children.
- Trial name
- NCT00231478
- Testing
- granisetron
- Where
- 11 sites in United States
- Volunteers
- 171 people
- Sponsor
- Hoffmann-La Roche
Anesthesia
A Multicenter, Open, Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Cipepofol Injection for General Anesthesia in Pediatric Patients Undergoing Elective Surgery
A multicenter, open, controlled, Phase III clinical study to evaluate the efficacy and safety of Cipepofol injection for general anesthesia in pediatric patients undergoing elective surgery
- Trial name
- NCT06391931
- Testing
- Cipepofol, Propofol
- Where
- China
- Volunteers
- 190 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Hypoplastic Left Heart Syndrome, Single Ventricle
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle
- Trial name
- APOLLON (NCT02781922)
- Testing
- Autologous cardiac stem cells (JRM-001)
- Where
- 4 sites in Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
ENT Disorder, Nasal Procedures
Pharmacokinetics, Safety, and Tolerability Study of GOPRELTO® Nasal Solution and NUMBRINO™ Nasal Solution
The purpose of this study is to assess the pharmacokinetic (PK) properties, safety and tolerability following a single dose administration of GOPRELTO® or NUMBRINO™ as an anesthetic for diagnostic procedures and surgeries on or…
- Conditions
- ENT Disorder, Nasal Procedures, Nasal Anesthesia, Nasal Mucosa Surgery
- Trial name
- NCT04792034
- Testing
- Cocaine Hydrochloride Nasal Solution
- Where
- 6 sites in United States
- Volunteers
- 40 people
- Sponsor
- LXO Ireland
Myocardial Ischemia, Heart Defects, Congenital
Spectroscopic Assessment of Myocardial Oxygenation Changes in Pediatric Heart Surgery
The goal of this observational study is to investigate the ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to observe and monitor changes in cardiac oxygen availability in pediatric…
- Conditions
- Myocardial Ischemia, Heart Defects, Congenital, Reperfusion Injury, Myocardial
- Trial name
- NCT07785141
- Where
- Finland
- Volunteers
- 30 people
- Sponsor
- Spectrocor
Local Analgesia Via Infiltration
A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients
The study is being conducted to evaluate the safety and efficacy of bupivacaine liposome injection for local infiltration analgesia in pediatric orthopedic surgery in the real world.
- Trial name
- NCT06344091
- Testing
- Bupivacaine Liposome Injection
- Where
- China
- Volunteers
- 232 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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
Pediatric Surgical Procedures, Adult Surgical Procedures
A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures
The main purpose of this study is to demonstrate acceptable performance and assess safety of the HARMONIC 700 Shears device in a post-market setting when used per the instructions for use in pediatric and adult surgical…
- Conditions
- Pediatric Surgical Procedures, Adult Surgical Procedures, Adult Gynecological Procedures, Adult Urological Procedures
- Trial name
- NCT06608485
- Testing
- HARMONIC 700 Shears
- Where
- 7 sites in United States, Canada and 1 more
- Volunteers
- 173 people
- Sponsor
- Ethicon Endo-Surgery
Postoperative Nausea and Vomiting
A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)
This two part study will determine the appropriate dosing regimen of aprepitant for the prevention of postoperative nausea and vomiting (PONV) in pediatric participants 6 months to 17 years of age, by assessing pharmacokinetic…
- Trial name
- NCT00819039
- Testing
- Aprepitant, Ondansetron
- Where
- 6 sites in United States, Brazil and 3 more
- Volunteers
- 98 people
- Sponsor
- Merck Sharp & Dohme LLC
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
General Anesthetic
HSK3486 (Cipepofol) Injectable Emulsion for Induction of General Anesthesia in Pediatric Subjects Undergoing Elective Surgery
This multicenter, randomized, double-blinded, propofol-controlled Phase 3b study enrolls pediatric subjects aged 3-17 years undergoing elective surgery with endotracheal intubation.
- Trial name
- NCT07510945
- Testing
- HSK3486, propofol
- Volunteers
- 400 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Pediatric Procedures, Adult Hepato-pancreato-biliary (HPB) Procedures
A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices
This prospective, single-arm, multi-center study will collect clinical data in a post-market setting for the pediatric population (general surgical procedures) and adult population (general, gynecological, urological, and…
- Conditions
- Pediatric Procedures, Adult Hepato-pancreato-biliary (HPB) Procedures, Adult Lower Gastrointestinal Procedures, Adult Gastric Procedures
- Trial name
- NCT05039021
- Testing
- HARMONIC 1100 Shears
- Where
- 7 sites in United States, Canada and 1 more
- Volunteers
- 265 people
- Sponsor
- Ethicon Endo-Surgery