Clinical trials: Targeted Temperature Management
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
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
Tinnitus, Tinnitus, Subjective
Noninvasive Therapy for Tinnitus
The goal of this interventional clinical study is to establish mild therapeutic hypothermia, delivered non-invasively to the structures of the inner ear, as a safe and repeatable therapeutic method for symptomatic relief of…
- Trial name
- NCT07071480
- Testing
- Cold pack-delivered mild therapeutic hypothermia
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Restorear Devices LLC
Targeted Temperature Management
Feasibility Study for VCool™ Intranasal Cooling System in Healthy Volunteers
The objective of this study is to evaluate the performance and safety of the VCool Intranasal Cooling System in healthy adult volunteers.
- Trial name
- NCT07361588
- Testing
- Targeted Temperature Management Intranasal Cooling System
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- NeuroIntact Inc.
Acute Myocardial Infarction
COOL-AMI EU Case Series Clinical Study
A single-center, prospective case series clinical study consecutively enrolling up to 10 patients with expected duration of 12 months or less.
- Trial name
- NCT02070913
- Where
- 23 sites in Czechia, Estonia and 6 more
- Volunteers
- 352 people
- Sponsor
- ZOLL Circulation, Inc., USA
Traumatic Brain Injury
Prospective, Interventional Study Evaluating the Feasibility and Safety of the Esophageal Cooling Device
The aim of this prospective, interventional study is to assess the feasibility and safety of the Esophageal Cooling Device in patients from suffering from traumatic brain injury who the treating physician is treating with…
- Trial name
- NCT02420639
- Testing
- Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.
- Where
- Ukraine
- Volunteers
- 12 people
- Sponsor
- Advanced Cooling Therapy, Inc., d/b/a Attune Medical
Cardiac Arrest
Antioxidant and NMDA Receptor Blocker Wins Anoxic Brain Damage of KorEa OHCA Patients
This study aims to investigate the efficacy and safety of Neu2000KWL, a neuroprotectant, in patients resuscitated from out-of-hospital cardiac arrest and receiving therapeutic hypothermia.
- Trial name
- AWAKE (NCT03651557)
- Testing
- Neu2000KWL High-dose group, Neu2000KWL Low-dose group
- Where
- 6 sites in South Korea
- Volunteers
- 150 people
- Sponsor
- GNT Pharma
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
Cardiac Arrest, Post Cardiac Arrest Syndrome
Lung-cOnservative Liquid VEntilation for the Induction of Ultra-Rapid COOLing After Cardiac Arrest
Out-of-hospital cardiac arrest (OHCA) affects over 356,000 individuals annually in the United States, with fewer than 10% surviving to hospital discharge, mirroring statistics from Europe.
- Trial name
- OverCool (NCT06798818)
- Testing
- Ultra-rapid therapeutic hypothermia induction by total liquid ventilation
- Where
- France
- Volunteers
- 24 people
- Sponsor
- ORIXHA
Ischemic Stroke
REperfusion With Cooling in CerebraL Acute IscheMia II
The primary objective of this study is to determine the feasibility and safety of achieving rapid hypothermia with the Proteus Intravascular Temperature Management (IVTM) system for patients experiencing acute ischemic stroke due…
- Trial name
- RECCLAIM-II (NCT03804060)
- Testing
- Thermogard XP3, Recanalization only
- Where
- 8 sites in United States
- Volunteers
- 90 people
- Sponsor
- ZOLL Circulation, Inc., USA
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
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
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
Out-Of-Hospital Cardiac Arrest
Finding the Optimal Cooling tempeRature After Out-of-HoSpiTal Cardiac Arrest
To assess the fraction of subjects surviving with good neurological outcome at 90 days for 3 different levels of hypothermia, in comatose survivors from out-of-hospital cardiac arrest.
- Trial name
- FROST (NCT02035839)
- Testing
- Target Temperature Management of 34°C, Target Temperature Management of 32°C, Target Temperature Management of 33°C
- Where
- 14 sites in Germany, Spain
- Volunteers
- 150 people
- Sponsor
- ZOLL Circulation, Inc., USA
Fever, Ischemic Stroke
Impact of Fever Prevention in Brain Injured Patients
This study will assess the impact of fever prevention on fever burden and short- and long-term neurologic outcomes in brain injured patients.
- Conditions
- Fever, Ischemic Stroke, Intracerebral Hemorrhage, Subarachnoid Hemorrhage
- Trial name
- INTREPID (NCT02996266)
- Testing
- Targeted Temperature Management, Standard Care
- Where
- 40 sites in United States, Australia and 4 more
- Volunteers
- 686 people
- Sponsor
- C. R. Bard
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.
Cardiac Arrest
Esophageal Temperature Management After Cardiac Arrest
To control patient's body temperature remains of major importance especially after cardiac arrest (CA). Therapeutic hypothermia (TH) targeted to 32-34°C is now recommended for most unconscious CA patients.
- Trial name
- THE-COOL (NCT02327871)
- Testing
- Esophageal cooling device (and usual standard procedure)
- Where
- France
- Volunteers
- 15 people
- Sponsor
- IST cardiology
Noise Exposure, Noise-induced Hearing Loss
Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for preservation of sensory structures in the cochlea after noise exposure. The main aims of the study are: 1.
- Conditions
- Noise Exposure, Noise-induced Hearing Loss, Noise; Adverse Effect, Mild Therapeutic Hypothermia
- Trial name
- NCT06729632
- Testing
- Cold pack-delivered mild therapeutic hypothermia
- Where
- United States
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Restorear Devices LLC
Skin Health
Evaluatation of a Microcurrent + Cold Therapy Device
The present study aims to assess use of a microcurrent and cryotherapy device on skin health over an 8-week period using an at-home device that provides 15-minutes of microcurrent + cold therapy once daily.
- Trial name
- NCT07510581
- Testing
- Acute Microcurrent Treatment, Acute Microcurrent + cold therapy, 8-week Chronic Use of Microcurrent + Cold Therapy
- Where
- United States
- Volunteers
- 112 people
- Sponsor
- Therabody, Inc.
Acute Myocardial Infarction
COOL AMI EU Pivotal Trial to Assess Cooling as an Adjunctive Therapy to PCI In Patients With Acute MI (Phase A)
The objective of this trial is to evaluate the safety and effectiveness of therapeutic hypothermia, using the ZOLL Proteus IVTM System, as an adjunctive therapy for patients presenting with acute anterior myocardial infarction…
- Trial name
- NCT03173313
- Testing
- Intravascular permissive hypothermia as an adjunct to PCI
- Where
- Slovenia
- Volunteers
- 111 people
- Sponsor
- ZOLL Circulation, Inc., USA