Clinical trials: Hypothermia
Cochlear Implants, Cochlear Implantation
Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are: 1.
- Conditions
- Cochlear Implants, Cochlear Implantation, Hearing Loss
- Trial name
- NCT06375278
- Testing
- Intra-Ear Canal Cooling Catheter
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Restorear Devices LLC
Hypothermia Due to Cold Environment
Clinical Evaluation of Effectiveness of the "Therm'Up" Heating Device
Here's a concise summary in English without the numbers: Hypothermia is defined as a core temperature below 35°C and occurs when the body loses more heat than it produces.
- Trial name
- NCT06788925
- Testing
- Patients support with survival coverage, Patients support with active thermic jacket
- Where
- France
- Volunteers
- 100 people
- Sponsor
- ThermoTrauma
Anesthesia Induced Hypothermia, Inadvertent Perioperative Hypothermia
Study to Evaluate Safety and Efficacy of Blanket Used to Prevent Anesthesia Induced Hypothermia
The investigation was designed as an Open-Label, Multicenter, Randomised, Controlled Investigation to Evaluate the Efficacy and Safety of the BARRIER® EasyWarm Active Self-Warming Blanket Used for Continuous Active Warming to…
- Trial name
- NCT01900067
- Testing
- BARRIER® EasyWarm Active Self-Warming Blanket
- Volunteers
- 271 people
- Sponsor
- Molnlycke Health Care AB
Cellular Injury and Post-Cryogenic Recovery, Cryogenic Cellular Stress
Evaluation of In-Vitro Cryo Therapeutic Protocols on Human Cell Samples (TWH-CRYO-001)
This laboratory-based study evaluates the effects of controlled cryogenic preservation on human cell samples using Truway Health's in-vitro cryo therapeutic methodology.
- Conditions
- Cellular Injury and Post-Cryogenic Recovery, Cryogenic Cellular Stress, Cold-Induced Cellular Injury, Thermal Injury Response
- Trial name
- CRYO-IVT (NCT07321028)
- Testing
- Standard Laboratory Cryopreservation Procedure, Enhanced Laboratory Cryopreservation Procedure, Normothermic Cell Culture Control
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Truway Health, Inc.
Cardiac Arrest
Pre-ROSC Intra-Nasal Cooling Effectiveness
The purpose of the study was to demonstrate the safety and feasibility of early intranasal cooling prior to return of spontaneous circulation (ROSC) in the emergency medical services (EMS) environment.
- Trial name
- PRINCE (NCT00808236)
- Testing
- RhinoChill, Control
- Where
- 15 sites in Belgium, Czechia and 3 more
- Volunteers
- 200 people
- Sponsor
- BeneChill, Inc
Hypothermia
Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes
The application of active warming to patients whether awake or under general anesthesia has been proven safe in numerous studies and it is common practice to use warmers.
- Trial name
- NCT02177903
- Testing
- Bair Paws Patient Adjustable Warming System
- Where
- Canada
- Volunteers
- 220 people
- Sponsor
- Solventum US LLC
Tinnitus, Tinnitus, Subjective
External Therapy for Tinnitus Management
The goal of this remote interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for the symptomatic relief of chronic tinnitus. The main aims of the study are: 1.
- Trial name
- NCT07017998
- Testing
- Cold pack-delivered mild therapeutic hypothermia
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Restorear Devices LLC
Cardiac Arrest
Therapeutic Hypothermia With IntraVascular Temperature Management (IVTM) in Post-Cardiogenic Cardiac Arrest and Post-Return of Spontaneous Circulation Patients in Japan
A multicenter, single-arm, prospective, interventional trial to evaluate therapeutic hypothermia with intravascular temperature management (IVTM) in post-cardiogenic cardiac arrest, post-return of spontaneous circulation (ROSC)…
- Trial name
- NCT01847482
- Testing
- ZOLL Intravascular Temperature Management System (IVTM)
- Where
- 10 sites in Japan
- Volunteers
- 26 people
- Sponsor
- ZOLL Circulation, Inc., USA
Cardiac Arrest
Induction of Mild Hypothermia in Resuscitated Cardiac Arrest Patients
The primary objectives of this study are to determine the safety and feasibility of inducing mild hypothermia using a non-invasive thermoregulatory device, the Medivance Arctic Sun Temperature Management System, in patients…
- Trial name
- NCT00282373
- Testing
- mild hypothermia
- Where
- 6 sites in United States
- Volunteers
- 64 people
- Sponsor
- Medivance, Inc.
End Stage Liver DIsease, Liver Failure
Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation
This is a prospective, multi-center, controlled, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart™ Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver…
- Trial name
- NCT05045794
- Testing
- VitaSmart™Liver Machine Perfusion System, Static cold storage
- Where
- 15 sites in United States
- Volunteers
- 228 people
- Sponsor
- Bridge to Life Ltd.
Cardiac Arrest
Phase 1 Study of HBN-1
Phase 1 First-in Human randomized, open-label, active control standard of care study of the safety of HBN-1 administered as pharmacologically induced hypothermia as an adjunct to standard of care targeted temperature management…
- Trial name
- NCT04094857
- Testing
- HBN-1
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Hibernaid, Inc
Severe Hypoxic Ischemic Encephalopathy, Moderate Hypoxic Ischemic Encephalopathy
Efficacy Study of Hypothermia Plus Magnesium Sulphate(MgSO4) in the Management of Term and Near Term Babies With Hypoxic Ischemic Encephalopathy
The purpose of this study is to assess whether the addition of a drug such as Magnesium sulphate while providing therapeutic hypothermia (or cooling) to babies who are asphyxiated at birth provides additional benefit to the…
- Trial name
- MagCool (NCT01646619)
- Testing
- Magnesium Sulphate
- Where
- 7 sites in Egypt, Malaysia and 4 more
- Volunteers
- 300 people
- Sponsor
- Sajjad Rahman
Inadvertent Perioperative Hypothermia, Preoperative Anxiety Experienced by the Patient
Evaluation of Core Body Temperature When Using Forced Air Warming or an Active Blanket to Prevent Perioperative Hypothermia
This investigation is undertaken to investigate if patient warming with BARRIER® EasyWarm active self-warming blanket differs compared to active warming with forced air warming in terms of core body temperature perioperatively.
- Trial name
- NCT02079311
- Testing
- Active self warming blanket, Forced air warming device
- Where
- 3 sites in Germany, Norway and 1 more
- Volunteers
- 55 people
- Sponsor
- Molnlycke Health Care AB
Total Aortic Arch Replacement
Near-Infrared Spectroscopy Comparison Study
The objective of this study is to validate Near-Infrared (NIRS) monitoring in patients undergoing circulatory arrest. This study will compare two-wavelength NIRS INVOS System, Somanetics; Troy, MI) with four-wavelength NIRS…
- Trial name
- NCT01352260
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Nonin Medical, Inc
End Stage Liver DIsease, Liver Failure
VitaSmart HOPE System: Bridge to HOPE Registry
This is a post-market, multicenter, single-arm, observational registry evaluating real-world use of the VitaSmart HOPE System under standard of care conditions.
- Trial name
- NCT07578441
- Testing
- hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditions
- Where
- United States
- Volunteers
- 5,000 people
- Sponsor
- Bridge to Life Ltd.
Acute Myocardial Infarction
COOL AMI EU Pilot Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction
COOL AMI EU Pilot Trial: A Multicenter, Prospective, Randomized Controlled Trial to Assess Cooling as an adjunctive Therapy to Percutaneous Intervention in Patients with Acute Myocardial Infarction.
- Trial name
- NCT02509832
- Testing
- Cooling + PCI, PCI only
- Where
- 13 sites in Austria, Estonia and 6 more
- Volunteers
- 100 people
- Sponsor
- ZOLL Circulation, Inc., USA
Hypoxic-Ischemic Encephalopathy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant…
- Trial name
- STAR (NCT05778188)
- Testing
- RLS-0071
- Where
- 15 sites in United States
- Volunteers
- 70 people
- Sponsor
- ReAlta Life Sciences, Inc.
Concussion, Mild
Pro-2-Cool Pivotal Trial II
This study is being conducted to determine the clinical safety and efficacy of Pro-2-Cool mediated head and neck cooling when applied after concussion and improved symptomatology among adolescent athletes as quantified by…
- Trial name
- NCT06929923
- Testing
- Pro2Cool Device
- Where
- 3 sites in United States
- Volunteers
- 66 people
- Sponsor
- TecTraum Inc.
Kidney Transplant, Kidney Failure
Hypothermic Machine Perfusion With Omnisol of Deceased Donor Kidneys Prior to Transplantation
Insufficient availability of organs from brain dead (DBD) and living donors has necessitated increased use of less than optimal organs from donation after cardiac death (DCD) or from extended criteria donors.
- Conditions
- Kidney Transplant, Kidney Failure, Renal and Urinary Tract Therapeutic Procedures, End Stage Renal Disease (ESRD)
- Trial name
- NEWHOPE (NCT07792317)
- Testing
- Omnisol organ preservation solution
- Where
- Netherlands
- Volunteers
- 15 people
- Sponsor
- Vivalyx GmbH
Mild Traumatic Brain Injury
Pro-2-Cool Device Clinical Study
This study is being conducted to quantify the clinical safety and efficacy of head and neck cooling when applied up to 8 days after mild traumatic brain injury (mTBI) among adolescents participating in sporting activities.
- Trial name
- NCT03511339
- Testing
- TecTraum device
- Where
- 5 sites in United States
- Volunteers
- 174 people
- Sponsor
- TecTraum Inc.