Tokyo, Oct. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059378) titled 'A Study on a New Test to See Blood Flow Using Light' on Oct. 13.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Kanto rosai hospital

Condition: Condition - patients who have undergone finger replantation or digital artery reconstruction Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to use photoacoustic imaging (PAI) to provide detailed three-dimensional visualization of the morphology and hemodynamics of anastomosed vessels in fingers that have survived after digital replantation. Specifically, the study aims to (i) evaluate the extent of arterial reconstruction following replantation and (ii) assess whether safe and effective vascular pathways can be identified preoperatively for planning secondary procedures. Conventional clinical assessment methods have been insufficient to fully delineate the course and patency of microvasculature, leaving surgeons reliant on empirical judgment; this study seeks to provide novel insights into long-term hemodynamics of replanted digits through three-dimensional imaging. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Photoacoustic imaging examination

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients who have undergone reconstructive surgery for limb or hand trauma, or healthy volunteers who have completed such treatment and are deemed by the principal investigator or subinvestigator to be in a suitable health condition for study participation. 2. Individuals aged 18 years or older at the time of obtaining consent. 3. Individuals who have provided written informed consent voluntarily. Key exclusion criteria - 1.Individuals who are pregnant or may possibly be pregnant. 2.Individuals who are taking photosensitizing agents used for photodynamic therapy (e.g., Photofrin). 3.Individuals deemed by the principal investigator or subinvestigator to be unsuitable for participation in this study, such as those whose health condition may be adversely affected by the imaging position or posture required for the study. Target Size - 10

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2024 Year 02 Month 13 Day Date of IRB - 2024 Year 02 Month 13 Day Anticipated trial start date - 2024 Year 04 Month 14 Day Last follow-up date - 2030 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067889

Disclaimer: Curated by HT Syndication.