Clinical trials: PSI
E04.525.190, Craniotomy
Case Series to Evaluate Patient Specific Implants (PSI) in Polyether Ether Ketone (PEEK) Performance After 2 Years
The primary objective of this retrospective study is to evaluate the percentage of patients with device related adverse events (infection, rejection, dislocation, fracture of the implant) in the first 24 months after implantation.
- Conditions
- E04.525.190, Craniotomy, Craniectomy
- Trial name
- NCT01282645
- Testing
- PSI in PEEK
- Where
- 30 sites in Austria, Belgium and 13 more
- Sponsor
- Synthes GmbH
Orthognathic Surgery
Condyle Repositioning Using PSI and Prebent Plates Osteosynthesis Versus Conventional Mandibular BSSO Set-back Surgery
Patients with skeletal class III malocclusion were allocated to two groups. Both proximal and distal segments were repositioned using osteotomy/screw holes and plate locating surgical guides with pre-bent plates osteosynthesis in…
- Trial name
- NCT05385133
- Testing
- Computer guided condylar position, Manual condylar position
- Where
- Egypt
- Volunteers
- 20 people
- Sponsor
- Cairo University
Postoperative Delirium, Postoperative Pain
Effect of Electroencephalography Guided General Anesthesia on Postoperative Delirium in Children
Participants aged 4-10 years (92 patients), who came to the Hospital Operating Room at the University Faculty of Dentistry with an indication for dental treatment under general anesthesia due to lack of cooperation, will be…
- Trial name
- NCT06400706
- Testing
- EEG guided general anesthesia
- Where
- Turkey (Türkiye)
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Aydin Adnan Menderes University
Total Knee Arthroplasty / Position of Customized X-Ray PSI Guides Using Optical Navigation
Zimmer CAS PSI X-Ray Knee in TKA (Total Knee Arthroplasty)
The objective of the observational study is to assess the positioning of customized guides designed from patients X-Rays (Zimmer® X-Ray PSI Knee) using optical navigation in primary total knee arthroplasty.
- Trial name
- NCT02504112
- Testing
- there is no intervention
- Volunteers
- 9 people
- Sponsor
- Zimmer Biomet
Procedural Sedation, Hypoxemia
HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation
This prospective randomized controlled trial aims to compare the effects of high-flow nasal oxygen (HFNO) and conventional face mask oxygen therapy on cerebral oxygenation during procedural sedation performed outside the…
- Conditions
- Procedural Sedation, Hypoxemia, Cerebral Oxygenation, SEDLine
- Trial name
- NCT07718295
- Testing
- High-Flow Nasal Oxygen (HFNO), Conventional Face Mask Oxygen
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Firat University
Adverse Event
Adverse Events Among Hospitalized Patients in China
The goal of this observational study is to learn about the incidence and characteristics of adverse events (AEs) among hospitalized patients in China and to compare 4 commonly used methods for detecting these events.
- Trial name
- NCT07705204
- Testing
- Not applicable- observational study
- Where
- China
- Volunteers
- 2,807 people
- Sponsor
- Peking Union Medical College Hospital
Maxillary Cyst
Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation
Surgical ablation of large maxillary cysts usually results in considerable hard and soft tissue deficits that ultimately affect the final esthetic and functional outcomes.
- Trial name
- NCT03265795
- Testing
- Poly Ether Ether Ketone PSI (patient specific implant).
- Volunteers
- 8 people
- Sponsor
- Cairo University
Hypnotic Effect
Monitoring of Hypnosis State During General Anesthesia With Propofol by Patient State Index From SEDLine®
The purpose of this study is the evaluation of possible relationships and correlation between PSI values obtained from the SEDLine® monitor and the infusion rate of propofol during general anesthesia.
- Trial name
- NCT02706665
- Testing
- SEDline monitor
- Where
- Spain
- Volunteers
- 12 people
- Sponsor
- Hospital Universitario de Canarias
Knee Disease, Knee Osteoarthritis
Biplanar PSI Slope-reducing MOWHTO With Tibial Tuberosity Serving as Hinge Axis: Cadaveric Study
Six cadaveric lower limbs will have PSI slope-reducing MOWHTO performed on and accuraccy of biplanar correction will be assessed.
- Conditions
- Knee Disease, Knee Osteoarthritis, Knee Injuries and Disorders
- Trial name
- NCT05448742
- Testing
- Biplanar PSI slope-reducing MOWHTO.
- Where
- Poland
- Volunteers
- 6 people
- Sponsor
- Artromedical Konrad Malinowski Clinic
Gingival Vascularization, Oral Soft Tissue Wound Healing
Analysis of the Reliability and Validity of Laser Speckle Contrast Imaging
This study is designed to validate laser speckle contrast imaging (LSCI) as a non-invasive method for measuring superficial gingival blood perfusion.
- Conditions
- Gingival Vascularization, Oral Soft Tissue Wound Healing, Laser Speckle Contrast Imaging, Periodontal Wound Healing
- Trial name
- LSCI (NCT07527351)
- Testing
- Laser Speckle Contrast Imaging
- Where
- Spain
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Universidad Complutense de Madrid
Anesthesia
Comparison of Effect of Equi-MAC Anesthetics on PSI
The aim of this study is to compare the patient state index values produced by equi-MAC of sevoflurane and desflurane in patients undergoing single-agent volatile anesthesia.
- Trial name
- NCT03587779
- Testing
- Sevoflurane, Desflurane
- Where
- South Korea
- Volunteers
- 74 people
- Sponsor
- Kangbuk Samsung Hospital
Anesthesia, Sedation
EEG-Guided Sedation in ERCP Procedures
Patients undergoing ERCP have a wide range from patients with poor general condition and septicaemia findings to outpatients who come as day patients without any other additional disease.
- Conditions
- Anesthesia, Sedation, Sedation Complication, Anesthesia, Intravenous
- Trial name
- ERCP-EEG (NCT06866886)
- Where
- Turkey (Türkiye)
- Volunteers
- 84 people
- Sponsor
- Ankara City Hospital Bilkent
Cardiopulmonary Bypass, Hypothermia; Anesthesia
Effect of Hypothermia on BIS and PSI Correlation During Cardiopulmonary Bypass
The goal of this observational study is to evaluate whether hypothermia affects the relationship between electroencephalography-derived indices during cardiac surgery in adult patients undergoing cardiopulmonary bypass.
- Conditions
- Cardiopulmonary Bypass, Hypothermia; Anesthesia, Depth of Anesthesia Monitoring
- Trial name
- NCT07508579
- Testing
- Simultaneous BIS and PSI Monitoring
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Sakarya University
Postoperative Cognitive Disorders
Impact of Combined PSi + NIRS Monitoring in the Prevention of Postoperative Cognitive Disorders in Cardiac Surgery.
Advances in cardiac medicine and anesthesia have made it possible to expand the indications for open heart surgery to increasingly older and more complex patients.
- Trial name
- NCT07267416
- Testing
- NIRS (Near Infrared Spectroscopy), SedLine®
- Where
- Belgium
- Volunteers
- 80 people
- Sponsor
- Brugmann University Hospital
Malocclusion
Finite Element Modelling of Le Fort I Osteotomy Fixation : PSI vs Miniplates
This study aimed to evaluate the biomechanical performance of patient-specific versus conventional fixation for Le Fort I osteotomy using subject-specific finite element models derived from real surgical plans.
- Trial name
- NCT07365657
- Testing
- In silico orthognathic surgery with customized implants digital only on 3D scanners
- Where
- France
- Volunteers
- 2 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Low Flow Anesthesia
Low-Flow Anesthesia Without Wash-in: Effects on Oxygenation and Depth of Anesthesia
This study aims to evaluate whether adjusting the fresh gas flow rate to low-flow immediately after intubation, without performing a wash-in, is a reliable approach with respect to depth of anesthesia and oxygenation.
- Trial name
- NCT07534839
- Testing
- Initiation of low-flow anesthesia without wash-in following intubation
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Erzincan Binali Yildirim Universitesi
CAD/CAM, Patient Specific Implant
Tooth and Bone-borne Cutting/Repositioning Guide and Patient-specific Implant(PSI)
Dentofacial deformity refers to a group of disorders characterized by malocclusion and facial asymmetry resulting from developmental abnormalities of the maxilla and mandible, which cause morphological and positional anomalies of…
- Conditions
- CAD/CAM, Patient Specific Implant, Orthognathic Surgery, Surgery-first
- Trial name
- PSI (NCT07634276)
- Testing
- bimaxillary surgery(Lefort I and SSRO)
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Peking Union Medical College
Odontogenic Cysts, Odontogenic Keratocyst
Patient Specific Implants (PSIs) for the Decompression of Odontogenic Cysts
This study aims to assess the feasibility of the decompression of odontogenic cysts using Patient Specific Implants anchored subperiosteally using osteosynthesis screws.
- Trial name
- NCT06688851
- Testing
- Preoperative Cone Beam Computed Tomography (CBCT) scan, Cystostomy, Histology to confirm the initial diagnosis
- Where
- Hungary
- Volunteers
- 20 people
- Sponsor
- Semmelweis University
Accidental Awareness During General Anesthesia
Comparison of Modulations of Motor Brain Activity and SedLine After Median Nerve Stimulation in General Anesthesia
To this date, no monitoring device can reliably detect episodes of accidental awakening during general anesthesia. One promising approach is the use of electroencephalography (EEG) to detect movement attempts via a brain-computer…
- Trial name
- NCT07267403
- Testing
- EEG Headset, SD LTM STIM (Micromed), SedLine®
- Where
- Belgium
- Volunteers
- 48 people
- Sponsor
- Brugmann University Hospital
Malocclusion, Abnormalities, Jaw
Personalized Titanium Plates vs CAD/CAM Surgical Splints in Maxillary Repositioning of Orthognathic Surgery
The purpose of this study is to determine whether personalized titanium plates can achieve better accuracy than CAD/CAM surgical splint in maxilla repositioning in orthognathic surgery, and evaluate the feasibility of this…
- Trial name
- NCT02914431
- Testing
- 3D Printing Personalized Titanium Plate
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University