Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastric Bypass Surgery
- Sponsor
- RSP Systems A/S
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Thermal damage threshold
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This clinical study has been initiated to assess the effect of laser exposure on human skin and determine the threshold for tissue damage. The tissue specific effects will be evaluated through histological evaluation. Excess skin from corrective surgery (gastric bypass or similar) will be donated for this study. Skin samples will be subjected to titrating laser treatment with varying laser intensity and exposure time.
Detailed Description
The dosimetry of laser induced hyperthermia and threshold for tissue damage will be evaluated. A dose escalation study will be performed by varying irradiance (mW) and time (minutes). Surface temperature will be monitored concurrently. Acute lesions occurring within 5 minutes of irradiation will be assessed and histological damage will be observed microscopically in slice sections of punch biopsies and qualitative assessed. Irradiation regimes above the anticipated threshold will be employed to properly titrate the irradiation necessary to elicit a thermal damage response.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female subject 18 years of age or older
- •Gastric bypass operated or similar
- •Excess abdominal skin to be removed surgically
- •Abdominal skin tone 4 or below
Exclusion Criteria
- •Extensive skin changes, tattoos or diseases on skin explant to be donated
- •Medical history or any condition that may in investigator's opinion compromise the subject's ability to participate.
Outcomes
Primary Outcomes
Thermal damage threshold
Time Frame: Within 3 months
Quantitative evaluation of laser induced damage by histological lesion in epidermis and dermis.