JPRN-jRCTs032190011
Completed
Phase 2
A multicenter trial for measuring tissue circulation with flexible optical probe - Multipoint tissue circulation monitoring v2.0
Tomioka Yoko0 sites51 target enrollmentApril 16, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Tomioka Yoko
- Enrollment
- 51
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This device can continuously monitor, calculate, and determine blood circulation risk, with results that are highly correlated with physician assessments. Furthermore, the device fit is tolerable for continuous wear for one week postoperatively, indicating that the device may play a significant role in free flap reconstruction. Through this clinical trial, we were able to evaluate the function of the device enough by comparing the risk rate and doctors's findings.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients who will have cosmetic/functional reconstruction surgery
- •2\.Patients 18 years or older
- •3\.Patients who have been informed about the study, and have agreed with it in written format.
Exclusion Criteria
- •1\.Pregnant woman
- •2\.Nursing mothers
- •3\.Observed infectious signs around the site for device installation
- •4\.Patients who are not capable to corporate to this study
Outcomes
Primary Outcomes
Not specified
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