NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs052200139

Registered date:19/02/2021

A Clinical Trial of Photoacoustic Imaging in the Planning of Free Flaps

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedconditions requiring reconsructive surgeries using free flaps
Date of first enrollment19/02/2021
Target sample size54
Countries of recruitment
Study typeInterventional
Intervention(s)The use of photoacoustic imaging in the planning of free flaps

Outcome(s)

Primary OutcomeSubjective evaluation (visibility and ease of use of vascular map) Objective evaluation (accuracy of the location of perforators)
Secondary OutcomeVisual properties of perforating vessels Anatomical variations of vessels Correspondence of findings from photoacoustic imaging and those in ICG tests during surgery

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1. Patients who are planned to undergo reconstructive surgeries using flaps at Kyoto Univ.'s Hospital 2. Aged 20 years or older at the time of the informed consent
Exclude criteria1. Pregnant or lactating women 2. Photosensitizer for photodynamic therapy 3. A cardiac pacemaker in their body 4. Severe systemic disease corresponding to ASA-PS (American Society of Anesthesiologists physical status classification) Class 4 or larger. 5. Infection at the examined body sites 6. Difficult in communicating or body positioning during examinations

Related Information

Contact

Public contact
Name Nagai Yoshiko
Address 54 Kawaharacho Shogoin Sakyoku Kyoto Kyoto Japan 606-8507
Telephone +81-75-751-3613
E-mail y_nagai@kuhp.kyoto-u.ac.jp
Affiliation Kyoto University Hospital
Scientific contact
Name Susumu Saito
Address 54 Kawaharacho Shogoin Sakyoku Kyoto Kyoto Japan 606-8507
Telephone +81-75-751-3613
E-mail susumus@kuhp.kyoto-u.ac.jp
Affiliation Kyoto University Hospital