Clinical trials: Intraoperative Monitoring
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
Spectroscopic Assessment of Tissue Oxygenation Changes During Vascular Surgery
This study is a single-center, observational study designed to collect tissue spectrometric data related to tissue oxygenation.
- Conditions
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Ischemia Vascular, Tissue Ischemia
- Trial name
- NCT07786623
- Volunteers
- 30 people
- Sponsor
- Spectrocor
Intraoperative Ureter Injury
Dose-escalation Study of a Contrast Agent for Delineation of Urological Anatomy in Minimally Invasive Surgery
The purpose of this clinical trial is to study the safety and efficacy of an investigational imaging agent for delineation/visualization of urologic anatomy in the setting of minimally invasive surgery.
- Trial name
- NCT03106038
- Testing
- Nerindocianine for Injection
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Li-Cor, Inc.
Focal Epilepsy, Intraoperative Monitoring
Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )
The objective of this prospective interventional monocentric clinical investigation is to evaluate the feasibility and performance of the flexible high-density SOFT ECoG electrode grids, manufactured by Neurosoft Bioelectronics…
- Trial name
- EpiGrid (NCT06205160)
- Testing
- SOFT ECoG subdural grid electrode
- Where
- Netherlands
- Volunteers
- 12 people
- Sponsor
- Neurosoft Bioelectronics SA
Brain Tumor Adult, Epilepsy
WISE Cortical Strip for Intraoperative Neurophysiological Monitoring
The WIN Study is a prospective, interventional, multi-center, open-label premarket study designed to confirm the safety, performance and intended use of the WISE Cortical Strip (WCS) for CE certification purposes.
- Trial name
- WIN (NCT03731455)
- Testing
- WISE Cortical Strip
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 32 people
- Sponsor
- Wise S.r.l.
Blood Loss, Surgical, Postoperative Hemorrhage
Study of the Hemorai Vysio Wearable Device for Monitoring Changes Related to Blood Loss in Patients During and After Surgery.
The goal of this clinical trial is to learn whether the Hemorai Vysio wearable device can be used safely and feasibly to track relative changes over time in tissue oxygen, hemoglobin-related signals, blood flow, and oxygen use…
- Trial name
- VYSIO-FEASIBIL (NCT07826637)
- Testing
- Wearable optical hemodynamic monitoring device
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Hemorai Inc
Hemodynamic Monitoring
The EU Hyprotect Registry
European, multicenter, prospective, observational registry in patients undergoing elective major non-cardiac surgery
- Trial name
- NCT04972266
- Testing
- AcumenTM Hypotension Prediction Index software
- Where
- 12 sites in France, Germany and 3 more
- Volunteers
- 702 people
- Sponsor
- Edwards Lifesciences
Flap Ischemia, Hypoxia
Spectroscopic Assessment of Tissue Oxygenation Changes in Plastic Surgical Flap Reconstructions
This study is a single-center, observational study designed to collect tissue spectrometric data.
- Trial name
- NCT07786610
- Volunteers
- 30 people
- Sponsor
- Spectrocor
Intraoperative Neurophysiological Monitoring
MINDZ-- Minimally Invasive Approach Pilot Study
This clinical investigation is a pilot, first-in-human (FIH) study designed to demonstrate proof of concept, safety, and functional performance of the MINDZ subdural electrode grid when used in relevant neurosurgical settings.
- Trial name
- MINDZ-MAP (NCT07543406)
- Testing
- MINDZ Subdural Electrode Grid
- Where
- Switzerland
- Volunteers
- 5 people
- Sponsor
- Neurosoft Bioelectronics SA
Surgery
Continuous Non-Invasive SpHb and PVI Monitoring on Intra-Operative and Post-Surgical Clinical Outcomes
The study evaluates the use of noninvasive hemoglobin with In Vivo feature and PVi monitoring using pulse-oximetry based technologies and their effect on the management of transfusion and infusion decisions and clinical outcomes…
- Trial name
- NCT02986789
- Testing
- In vivo SpHb and PVi Monitoring
- Volunteers
- 43 people
- Sponsor
- Masimo Corporation
Intraoperative Monitoring, Spinal Diseases
Intraoperative Monitoring (IOM) Patient Registry
The primary objective of this study is to evaluate the rate of new or worsening neurologic deficits and/or radiculopathy following lumbar or cervical surgery in light of IOM using neurological testing (motor and sensory) in the…
- Trial name
- IOM (NCT02187653)
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- DC2 Healthcare
Pain
ADVANCE: Assessment for Defining Variability in Anesthesia Through Novel Clinical EEG
The present study is designed to compare prospectively whether sBIS, sEMG, or CVI variability (brain monitoring) can be used to predict unwanted intraoperative responses (high blood pressure, fast heart rate, tearing, etc.) to…
- Trial name
- CVI (NCT00689130)
- Where
- 4 sites in United States, Spain
- Volunteers
- 120 people
- Sponsor
- Medtronic - MITG
Intervertebral Disc Degeneration, Stenosis, Spinal
Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure
This study is designed to evaluate the clinical utility of a known intraoperative neuromonitoring modality (SSEP) using saphenous nerve as the site of stimulation to identify changes to the lumbar nerves which may be at risk…
- Conditions
- Intervertebral Disc Degeneration, Stenosis, Spinal, Spondylolisthesis, Spinal Deformity
- Trial name
- NCT05648474
- Testing
- Somatosensory evoked potential [SSEP] intraoperative monitoring
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Alphatec Spine, Inc.
Coronary Artery Disease, Heart Valve Diseases
Spectroscopic Assessment of Intramyocardial Oxygen Saturation Feasibility During Open-heart Surgery
This traditional feasibility study aims to capture preliminary safety and effectiveness information on a near-final Investigational Device design to adequately plan the forthcoming pivotal study.
- Trial name
- NCT05479968
- Testing
- Spectrocor device
- Where
- Finland
- Volunteers
- 15 people
- Sponsor
- Spectrocor
Coronary Artery Disease, Heart Valve Diseases
Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery
The goal of this observational study is to test in the safety and performance of intraoperative myocardial spectroscopic measurement in open-heart surgery patients The main questions it aims to answer are: The Devices can record…
- Trial name
- ECS (NCT06084091)
- Testing
- Myocardial spectrometric measurement
- Where
- Finland
- Volunteers
- 40 people
- Sponsor
- Spectrocor
Temperature Monitoring, Intraoperative
Clinical Accuracy Validation of the Moni-Patc Temperature Monitoring Patch During Surgery (Compared With Esophageal and Bladder Temperature)
Moni-Patc Temperature Monitoring Patch System, a non-invasive, continuous temperature monitoring device designed to estimate core body temperature by applying a Sensor to the neck.This clinical accuracy validation study aims to…
- Trial name
- Moni-Patch OR (NCT07397065)
- Testing
- Moni-Patc Temperature Monitoring Patch System
- Volunteers
- 30 people
- Sponsor
- Murata Vios, Inc.
Intraoperative Ureter Injury
Open-label Study to Evaluate Nerindocianine as a Surgical Aid in Ureter Delineation During Minimally Invasive Surgery
Phase 2, multicenter, efficacy and safety study evaluating the use of nerindocianine for the delineation of abdominopelvic ureter anatomy via near infrared fluorescence imaging during minimally invasive lower abdominal surgery…
- Trial name
- NCT04636567
- Testing
- Nerindocianine for injection
- Where
- 2 sites in United States
- Sponsor
- Li-Cor, Inc.
Urinary Incontinence, Erectile Dysfunction
Intraoperative Nerve Monitoring During Robot-assisted Laparoscopic Prostatectomy
The purpose of this study is to determine whether the use of intraoperative nerve monitoring during robotic-assisted laparoscopic prostatectomy surgery improves post-surgery urinary continence and erectile function.
- Trial name
- NCT02446808
- Testing
- Intraoperative nerve monitoring
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- ProPep Surgical, LLC