NCT03402347

Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: RSP Systems A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Bypass Surgery

Interventions

Type	Name	Description
RADIATION	Non-ionising radiation	Laser regimes will be applied to ex vivo skin samples.

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-06-16
• Completion: 2019-06-16
• First posted: 2018-01-18
• Last updated: 2019-07-02

Locations

1 site across 1 country: Denmark