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.
Normothermic Machine Perfusion (NMP) of Deceased Donor Kidneys
Registry Analysis of Deceased Donor Kidney Transplant Outcomes
This study uses existing transplant data obtained from a national public donor registry operated by the Organ Procurement and Transplant Network (OPTN) under Health Resources and Services Agency (HRSA) to evaluate outcomes…
- Trial name
- NCT07530991
- Where
- United States
- Volunteers
- 3,500 people
- Sponsor
- Chris Jaynes
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.
Traumatic Brain Injury
Normothermia Protocol for Traumatic Brain Injury Patients
Comparison between a normothermia protocol and current protocol (acetaminophen plus blankets) 1. Normothermia Protocol is successful in achieving and maintaining normal temperature in moderate to severe Traumatic Brain Injury…
- Trial name
- NCT01354509
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Medivance, 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 for Neurogenic Fever
The objective of this study is to evaluate the efficacy 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, Seizures, Metabolic Encephalopathy
- Trial name
- NCT06038513
- Testing
- Transnasal Thermal Regulating Device
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- CoolTech LLC
Kidney Transplantation
Ex Vivo Normothermic Perfusion in Kidney Transplantation.
A multicenter, prospective and open-label clinical investigation to evaluate the viability, performance and safety of ex vivo normothermic perfusion in kidney transplantation from DCD and DBD donors.
- Trial name
- KidneyARK (NCT05175885)
- Testing
- Ex vivo normothermic perfusion, Cold preservation
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Ebers Medical Technology, S.L.
Lung Transplant
An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant
The XVIVO Registry is to collect standard of care clinical data from "all-comers" who are transplanted with an EVLP lung treated with the XVIVO Perfusion System™ in order to assess the long-term performance of the device, and…
- Trial name
- NCT05101460
- Testing
- XVIVO Perfusion System (XPS™) with STEEN Solution™
- Where
- United States
- Volunteers
- 315 people
- Sponsor
- XVIVO Perfusion
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
Lung Transplantation
Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation
The use of ex vivo lung perfusion (EVLP) will allow for a secondary evaluation technique for donor lungs that fail to meet standard acceptability criteria.
- Trial name
- HELP (NCT01190059)
- Testing
- Ex vivo lung perfusion with Steen Solution™
- Where
- Canada
- Volunteers
- 22 people
- Sponsor
- XVIVO Perfusion
Lung Transplant
Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs
Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques.
- Trial name
- NCT01365429
- Testing
- XPS™ with Steen Solution™
- Where
- 18 sites in United States
- Volunteers
- 252 people
- Sponsor
- XVIVO Perfusion
Liver Transplantation
OrganOx Metra® New Enrollment PAS
The objective of the OrganOx metra® New Enrollment Post-Approval Study is to collect data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on the OrganOx according to the current…
- Trial name
- NCT05526326
- Testing
- Transplant with normothermic machine perfused (NMP) donor liver
- Where
- 10 sites in United States
- Volunteers
- 315 people
- Sponsor
- OrganOx Ltd.
Neoplasms
A Study of ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan
N-cadherin, a protein involved in blood vessel cell binding and on the surface of many tumor cells, is increased as cancer progresses. ADH-1 blocks N-cadherin.
- Trial name
- NCT00421811
- Testing
- ADH-1, melphalan
- Where
- 7 sites in United States
- Volunteers
- 56 people
- Sponsor
- Adherex Technologies, Inc.