Clinical trials: Normothermia
Lung Diseases
Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility
The objective of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end…
- Trial name
- NCT03641677
- Testing
- Centralized Lung Evaluation System, Lung Transplant
- Where
- 13 sites in United States
- Volunteers
- 174 people
- Sponsor
- Lung Bioengineering Inc.
Liver Transplantation
WP02 Continued Access Study
The single-arm continued access phase will be used to collect additional effectiveness and safety data to support the objectives and outcomes of the original IDE pivotal study.
- Trial name
- NCT04862156
- Testing
- Normothermic Machine Perfusion (NMP)
- Where
- 7 sites in United States
- Volunteers
- 19 people
- Sponsor
- OrganOx Ltd.
Lung Disease
Extending Preservation and Assessment Time of Donor Lungs Using the Toronto EVLP System™ at a Dedicated EVLP Facility
This is a safety study to compare the safety of receiving a lung treated with the Toronto EVLP System™ by SPONSOR in SPONSOR's dedicated facility against standard lung transplantation.
- Trial name
- NCT02234128
- Testing
- Toronto EVLP System™
- Where
- 8 sites in United States
- Volunteers
- 118 people
- Sponsor
- Lung Bioengineering Inc.
Liver Transplantation
WP01 - Normothermic Liver Preservation
A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine profusion with static cold storage in human liver transplantation.
- Trial name
- NCT02775162
- Testing
- Normothermic Machine Perfusion (NMP), Standard of Care (Ice)
- Where
- 15 sites in United States
- Volunteers
- 267 people
- Sponsor
- OrganOx Ltd.
Stroke, Ischemic, Stroke Hemorrhagic
Transnasal Induction of Normothermia in Febrile Stroke Patients
The objective of this study is to evaluate safety and performance of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic, Fever, Seizures
- Trial name
- NCT03360656
- Testing
- Transnasal Thermal Regulating Device
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- CoolTech LLC