Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage

RSP Systems

Status

Completed

Conditions

Gastric Bypass Surgery

Treatments

Radiation: Non-ionising radiation

Study type

Interventional

Funder types

Industry

Identifiers

NCT03402347

RSP-11

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.