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PHOTOTHERA LASER SYSTEM FEASIBILITY ASSESSMENT

PHOTOTHERA LASER SYSTEM FEASIBILITY ASSESSMENT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-016-04
Enrollment
60
Registered
2004-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

photothera laser system Type of group
photobioestimulation will be applied Group name:false procedure (placebo) Type of group
Infrared energy will be applied without photo-stimulation.

Sponsors

PHOTOTHERA INC.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The Subject is at least 40 years old at the time of detection, but has not reached his 85th birthday. The Subject suffers from acute ischemic stroke. Possibility of starting treatment with photothera laser system within 24 hours of the start of the ACV The subject and / or his / her legal representative give their informed consent before taking the study. The Subject wishes to participate in this study for at least 3 months after the start of the ACV.

Exclusion criteria

Exclusion criteria: The Subject has been presented to the Community hospital more than 24 hours after the start of the ACV. Evidence of intracranial, subdural or subarachnoid hemorrhage in the CT scan The subject is a candidate for intravenous administration of tissue plasminogen activator (tPA) for the treatment of acute ischemic stroke and is administered tPA. The Subject had convulsions at the beginning of the ACV. Serum glucose greater than 400 mg / dL or less than 40 mg / dL.

Design outcomes

Primary

MeasureTime frame
Outcome name:Global Evolution Scale Measure:The average percentage change of the Global Evolution Scale from baseline to 90 days. Timepoints:90 days

Secondary

MeasureTime frame
Outcome name:survival Measure:Period of free survival of adverse events related to the procedure in 3 months Timepoints:3 month

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)