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Blood Circulation Disorder clinical trials

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NCT ID: NCT06079255 Not yet recruiting - Carbon Dioxide Clinical Trials

Ischemia Detection During Development of Acute Compartment Syndrome

IDEA
Start date: December 15, 2023
Phase:
Study type: Observational

This is an open, observational, prospective, descriptive, single-centre study including 60 patients. The study is designed to investigate if IscAlert sensor system can be used for reliable and continuous tissue carbon dioxide (pCO2)- and temperature monitoring in muscular tissue in lower extremity in patients at risk of developing acute compartment syndrome.

NCT ID: NCT05511064 Recruiting - Clinical trials for Deep Vein Thrombosis

CEFID-II (CEra Flow Improves DVT-II)

Start date: December 22, 2022
Phase: N/A
Study type: Interventional

For Deep Vein Thrombosis (DVT) risk groups, the effect and safety of blood circulation improvement before and after application are evaluated using an investigational device (model name CGM MB-1701).

NCT ID: NCT05487820 Recruiting - Surgery Clinical Trials

Detecting Tissue Ischemia in Reconstruction Flaps by a Novel CO2 Biosensor (DIMENSION-study)

DIMENSION
Start date: October 13, 2023
Phase: N/A
Study type: Interventional

The investigators will test if changes in CO2 is detected postoperatively in ischemic tissue in a reconstructed flap. IscAlert is measuring continuously CO2 in muscular and subcutaneous tissue. IscAlert is inserted distal to the operative field into normal muscle and/or subcutaneous tissue in the reconstructed flap. Local tissue CO2 and temperature will be monitored continuously postoperatively until maximal 10 days. If a reduced or totally obstructed blood flow appear (thrombosis), an increase in tissue CO2 and a lower local temperature will emerge rapidly as a sign of ischemia. This will be detected by the sensor which will alarm the investigators. This will lead to assessment of the reconstructed flap and if restricted blood flow is diagnosed, a reoperation or other intervention will be performed. 56 patients will be enrolled to undergo the procedures. The IscAlert will be removed from the patient before the patient is discharged from the hospital or a maximum of 10 days (the event that occurs first). 360 devices are planned to be used in this clinical study.

NCT ID: NCT05469282 Completed - Clinical trials for Deep Vein Thrombosis

CEFID-I (CEra Flow Improves DVT-1)

Start date: August 22, 2022
Phase: N/A
Study type: Interventional

The study is a single center clinical trial to evaluate the efficacy and safety of blood circulation improvement using an investigational medical device, which is a product on the market and it's name is Ceragem Master V6, for the risk group of Deep Vein Thrombosis (DVT) and the ordinary person. The study compares before and after the application by one time application.

NCT ID: NCT05297266 Recruiting - Ischemia Clinical Trials

Early Discovery of Ischemia After Replantation Surgery of the Extremities

EDIR
Start date: November 15, 2022
Phase: N/A
Study type: Interventional

Investigators will test if changes in CO2 is detected postoperatively in ischemic tissue in a replanted extremity of a traumatically amputated upper or lower extremity. IscAlert is measuring continuously CO2 in muscular and subcutaneous tissue. IscAlert is inserted distal to the operative field into normal muscle and/or subcutaneous tissue in the replanted extremity. Local tissue CO2 and temperature will be monitored continuously postoperatively for the next 10 days. If a reduced or totally obstructed blood flow appear (thrombosis), an increase in tissue CO2 and a lower local temperature will emerge rapidly as a sign of ischemia. This will be detected by the sensor which will alarm the investigators. This will lead to assessment of the replanted extremity and if restricted blood flow is diagnosed, a reoperation will be performed. After reoperation new sensors will be implanted for another ten days if applicable. Sixty patients will be enrolled to undergo the procedures. The IscAlert will be removed from the patient before the patient is discharged from the hospital or a maximum of 10 days (the event that occurs first). 500 devices is planned to be used in this clinical study.

NCT ID: NCT04893473 Withdrawn - Ischemia Clinical Trials

New Method for Real-time Detection of Tissue Ischemia

ISCALERT
Start date: May 14, 2021
Phase:
Study type: Observational

This is a prospective, single arm, open, single centre clinical investigation designed to examine the feasibility and safety of the IscAlertâ„¢ device in patients scheduled for limb (arm/leg) surgery with tourniquet. IscAlert is measuring carbon dioxide in muscular and subcutaneous tissue. IscAlert is inserted into normal muscle and subcutaneous tissue in ischemic (operated limb with a tourniquet) and non-ischemic limb (non-operated limb).After the tourniquet is inflated, ischemia develops in the muscles and subcutaneous tissue. This will result in an increase in carbon dioxide, which will be detected by the sensor on the operated extremity, while the sensor on the non-operated will show normal values. After releasing the tourniquet cuff, the muscle will be reperfused and the carbon dioxide level is expected to decrease into normal levels. 50 number of patients will be enrolled to undergo the procedures. The IscAlert will be removed from the patient before the patient is discharged from the operating room, but in 25 of the patients, IscAlertâ„¢ will be inserted for 72 hours in the operated extremity after the end of surgery. After this, the sensors are removed.250 Devices is planned to be used in this clinical study.

NCT ID: NCT04879875 Completed - Ischemia Clinical Trials

New Method for Real-time Detection of Tissue Ischemia (ISCALERT)

ISCALERT
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

This is a prospective, single arm, open, single centre clinical investigation designed to examine the feasibility and safety of the IscAlertâ„¢ device in patients scheduled for limb (arm/leg) surgery with tourniquet. IscAlert is measuring CO2 in muscular and subcutaneous tissue. IscAlert is inserted into normal muscle and subcutaneous tissue in ischemic (operated limb with a tourniquet) and non-ischemic limb (non-operated limb).After the tourniquet is inflated, ischemia develops in the muscles and subcutaneous tissue. This will result in an increase in CO2, which will be detected by the sensors on the operated extremity, while the sensors on the non-operated will show normal values. After releasing the tourniquet cuff, the muscle will be reperfused and the CO2 level is expected to decrease into normal levels. 50 number of patients will be enrolled to undergo the procedures. The IscAlert will be removed from the patient before the patient is discharged from the operating room, but in 25 of the patients, IscAlertâ„¢ will be inserted for 72 hours in the operated extremity after the end of surgery. After this, the sensors are removed. 250 Devices is planned to be used in this clinical study.

NCT ID: NCT04396288 Completed - Clinical trials for Bone Diseases, Metabolic

Ultrasound Imaging-based Measurement of Intra-osseous Vascular Response

Start date: September 14, 2021
Phase: N/A
Study type: Interventional

Blood circulation within bone is thought to have a key role in bone growth, in fracture healing and in the development of bone diseases like osteoporosis. Current medical imaging techniques such as conventional ultrasonography fail to detect blood circulation within bone. The investigators propose to develop a new type of ultrasonography called intraosseous functional ultrasonography that will enable the detection and the characterization of blood circulation in solid bone tissue, marrow and soft tissues surrounding bone (muscle for instance). Because most soft tissues are essentially made of water, the speed of sound in soft tissues is close to that in water and it varies only a little between different types of soft tissues. For this reason, clinical ultrasound scanners used for ultrasonography assume that the speed of sound in the human body is the same for all types of soft tissues. This assumption is reasonable in soft tissues, but it does not hold in bone because solid bone tissue is much stiffer than soft tissues. Seismologists have extensive experience in producing images of the structure of the Earth based on the analysis of elastic waves which follow the same laws of Physics as ultrasound waves. The subsurface of the Earth contains layers of solid materials and liquids, consequently it is very similar to a region of the human body containing bone and soft tissues. Therefore the investigators will first work on the adaption of time-tested seismic imaging methods to make ultrasonography of bone possible. Once a correct image of bone is obtained, the investigators will use an ultrasound scanner dedicated to research to repeat this image hundreds of times per second, very much like a slow motion video. Because blood is moving while bone is still, the intensity in the image is being slightly changed where blood is moving. Thus the analysis of these changes makes it possible to detect and characterize blood flow within bone. In this way the investigators expect to be able to detect blood flowing with a speed as low as a few millimeters per second. Finally the sensitivity of the technique to detect and characterize blood circulation in bone will be evaluated in patients at the hospital and in healthy volunteers. The success of this work will help gaining knowledge on the role of blood circulation within bone. In the long term, it may help in the diagnosis of bone diseases.

NCT ID: NCT03700216 Recruiting - Clinical trials for Blood Circulation Disorder

Construction of the Evaluation System of Limb Blood Circulation After Fracture of Limbs in Children

Start date: October 1, 2018
Phase:
Study type: Observational

This study is aimed to construct a multi-parameter early-warning model based on usage of mannitol, using multi-factor regression and combining with previous clinical experience, literature, expert opinions. The investigators will evaluate the predictive value of the model for mannitol usage and gypsum cutting open through cohort study verification.