Clinical trials: Neonatal Surgery
Congenital Afibrinogenemia, Hypofibrinogenemia
FIB Grifols Congenital Deficiency for On-demand Treatment and Surgical Prophylaxis
This is a phase 3, multi-center, prospective, open-label, single-arm, clinical trial to be carried out in subjects with congenital fibrinogen deficiency manifested as afibrinogenemia or severe hypofibrinogenemia.
- Trial name
- NCT04636268
- Testing
- FIB Grifols
- Sponsor
- Instituto Grifols, S.A.
Von Willebrand Disease
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
The main aim of the study is to check effectiveness, side effects, and tolerability of vonicog alfa (recombinant von Willebrand factor [rVWF]), with or without ADVATE, in the treatment and control of nonsurgical bleeding events…
- Trial name
- NCT02932618
- Testing
- Vonicog alfa, Antihemophilic Factor (Recombinant)
- Where
- 46 sites in United States, Austria and 11 more
- Volunteers
- 47 people
- Sponsor
- Baxalta now part of Shire
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
Alzheimer's Disease
Randomized, Controlled Study Evaluating CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease
The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment of Alzheimer's disease. CERE-110 is an experimental drug that is designed to help nerve cells in the brain function better.
- Trial name
- NCT00876863
- Testing
- CERE-110: Adeno-Associated Virus injection Surgery
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Sangamo Therapeutics
Skin Laxity of Abdomen, Thighs, Chest, Back, and Neck
Suture Granuloma in Body Contouring Surgery
The purpose of this study is to evaluate the effect of different suture material on the incidence of suture granuloma.
- Trial name
- NCT00223132
- Testing
- Absorbable sutures
- Where
- United States
- Sponsor
- Medtronic - MITG
Cardiac Surgery
Performance of Pulse Oximeter Sensors in Neonates
Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples during cardiac surgery.
- Trial name
- NCT03870373
- Testing
- Pulse Oximeter
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Taiwan Aulisa Medical Devices Technologies, Inc.
Mucopolysaccharidosis (MPS)
Mucopolysaccharidosis (MPS) I, II, and VI Screening in a High-Risk Population With Previous Surgical Repair or Presence of Inguinal and/or Umbilical Hernia in Combination With Pediatric ENT Surgery (The HATT Project)
Mucopolysaccharidosis (MPS) type II (MPS II; Hunter syndrome) is a rare, X-linked disease caused by a deficiency of the lysosomal enzyme iduronate-2-sulfatase (I2S) and occurs almost exclusively in boys, with an incidence of…
- Trial name
- NCT02095015
- Where
- 14 sites in United States, Canada and 5 more
- Volunteers
- 159 people
- Sponsor
- Shire
Primary Osteoarthritis, Post-Traumatic Arthritis
AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study
This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.
- Conditions
- Primary Osteoarthritis, Post-Traumatic Arthritis, Inflammatory Joint Disease, Femoral Neck Fracture
- Trial name
- NCT03357445
- Testing
- Avantage Reload cup
- Where
- 4 sites in France, Slovenia
- Volunteers
- 500 people
- Sponsor
- Zimmer Biomet
Congenital Bleeding Disorder, Haemophilia A
Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.
This trial is conducted globally. The aim of this trial is to evaluate the haemostatic effect of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.
- Trial name
- pathfinder™3 (NCT01489111)
- Testing
- turoctocog alfa pegol
- Where
- 70 sites in United States, Australia and 19 more
- Volunteers
- 36 people
- Sponsor
- Novo Nordisk A/S
Neonatal Disease, Post-Surgical Complication
Cardiac Surgery Recovery in Infants Assessed Using Neoneur Feeding System
A prospective non-randomized longitudinal design of 30-40 infants from initiation of oral feeding until discharge to track feeding changes as a potential indicator of surgical recovery.
- Conditions
- Neonatal Disease, Post-Surgical Complication, Cardiac Disease
- Trial name
- NCT06569641
- Testing
- Neoneur Feeding System
- Volunteers
- 35 people
- Sponsor
- Neoneur LLC
Antithrombin III Deficiency
Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery
Patients with hereditary antithrombin deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures.
- Trial name
- NCT00110513
- Testing
- Recombinant human antithrombin (rhAT)
- Where
- 17 sites in United States, Australia and 6 more
- Volunteers
- 18 people
- Sponsor
- rEVO Biologics
Primary Osteoarthritis, Post-Traumatic Osteoarthritis of Hip
Avenir® Cemented Hip Stem - PMCF
The objective of this post-market clinical follow-up study is to confirm the safety and performance of the Avenir® Cemented Hip stem when used in primary total hip arthroplasty.
- Conditions
- Primary Osteoarthritis, Post-Traumatic Osteoarthritis of Hip, Femoral Neck Fractures, Femoral Head Necrosis
- Trial name
- NCT03396224
- Where
- 3 sites in Belgium, France
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
Hemophilia
BAY14-2222 Continuous Infusion in Surgeries
Phase III study, to evaluate the efficacy and safety of continuous infusion of rFVIII-FS in the treatment of patients with hemophilia A undergoing major elective surgery by achieving the required therapeutic concentrations.
- Trial name
- NCT00606060
- Testing
- Kogenate (BAY14-2222)
- Where
- Israel
- Volunteers
- 15 people
- Sponsor
- Bayer
Hemophilia A
Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery
The primary objective of this clinical research study is to evaluate the safety and efficacy of ReFacto in subjects with hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local…
- Trial name
- NCT00092976
- Testing
- ReFacto
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Heart Diseases, ASD - Atrial Septal Defect
Abbott Structural Heart Device Registry
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting.
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale
- Trial name
- SH-Registry (NCT06590467)
- Testing
- Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices
- Where
- 36 sites in United States, Denmark and 8 more
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices
Ulcerative Colitis, Familial Polyposis
An Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery
This will be a prospective, multi-center, randomized, single blind study to collect and evaluate post-market clinical data on the SprayShield Adhesion Barrier System as an adjuvant to good surgical technique for the reduction of…
- Trial name
- NCT01002287
- Testing
- SprayShield Adhesion Barrier System, Good Surgical Technique Alone
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Integra LifeSciences Corporation
Hemophilia A
Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections (BI) or continuous infusion…
- Trial name
- NCT00243659
- Testing
- ReFacto AF
- Where
- 17 sites in United States, Australia and 6 more
- Volunteers
- 30 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Hemophilia A
Phase 3 Efficacy and Safety Study of BAX 855 in Severe Hemophilia A Patients Undergoing Surgical Procedures
The purpose of the study is to evaluate the efficacy and safety of BAX 855 in severe hemophilia A previously treated (PTP) males, 12 to 65 years of age who are undergoing elective surgical or other invasive procedures.
- Trial name
- NCT01913405
- Testing
- PEGylated Recombinant factor VIII (rFVIII)
- Where
- 22 sites in United States, Bulgaria and 7 more
- Volunteers
- 30 people
- Sponsor
- Baxalta now part of Shire
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.
Thyroid Eye Disease (TED), Graves Ophthalmopathy
Prospective Observational Study of Smartphone-Based AI Self-Monitoring During Non-Surgical Treatment for Thyroid Eye Disease (THYROSCOPE)
This prospective observational study evaluates the feasibility and clinical utility of a smartphone-based artificial intelligence (AI) self-monitoring system in adults with thyroid eye disease (TED) undergoing non-surgical…
- Conditions
- Thyroid Eye Disease (TED), Graves Ophthalmopathy, Thyroid Associated Ophthalmopathies
- Trial name
- THYROSCOPE-TED (NCT07623993)
- Testing
- Smartphone-based AI self-monitoring application (Glandy CAS/EXO/LID)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- THYROSCOPE INC.