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A Study on a New Test to See Blood Flow Using Light

Photoacoustic Imaging for Postoperative Assessment of Circulation after Digital Replantation and Digital Artery Reconstruction: An Exploratory Clinical Study - PAI test for reconstructed vessels

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059378
Enrollment
10
Registered
2025-10-13
Start date
2024-04-14
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

patients who have undergone finger replantation or digital artery reconstruction

Interventions

Sponsors

Kanto rosai hospital
Lead Sponsor
Luxonus Inc.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
1.Three-dimensional morphological assessment of digital vessels after replantation or arterial reconstruction using photoacoustic imaging (PAI) 2.Evaluation of vascular patency and blood flow using PAI, including estimation of oxygenation via S-factor analysis 3.Visibility and reproducibility of vascular imaging in digits followed for more than six months postoperatively 4.Feasibility and image quality of PAI acquisition under different hand positioning and stabilization methods (e.g., water immersion, water bag, or gel)

Countries

Japan

Contacts

Public ContactSatoshi Kamekura

Kanto rosai hospital the Dept. of Orthopedics

fkatsu@hotmail.com0444113131

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026