Monitoring tissue circulation with flexible optical probe

Phase 2

• Conditions: Planned reconstruction patients using microsurgery for congenital disease,trauma or tumor resections; free flap transplantation thrombosis microsurgery; D046650

• Registration Number: JPRN-jRCTs032190011
• Lead Sponsor: Tomioka Yoko

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-16
• Study Completion: 2019-10-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified