A Clinical Trial of Photoacoustic Imaging in the Planning of Free Flaps
Phase 1
Recruiting
- Conditions
- conditions requiring reconsructive surgeries using free flapsHead and neck cancer, Breast cancer
- Registration Number
- JPRN-jRCTs052200139
- Lead Sponsor
- Saito Susumu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
1. 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
Exclusion Criteria
1. 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjective evaluation (visibility and ease of use of vascular map)<br>Objective evaluation (accuracy of the location of perforators)
- Secondary Outcome Measures
Name Time Method Visual properties of perforating vessels <br>Anatomical variations of vessels<br>Correspondence of findings from photoacoustic imaging and those in ICG tests during surgery