Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage

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Rėmėjai

RSP Systems A/S

KLINIKINIS TYRIMAS: NCT03402347

BioSeek: nct03402347

Raktažodžiai

karščiavimas

Santrauka

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.

apibūdinimas

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.

Datos

Paskutinį kartą patikrinta:	06/30/2019
Pirmasis pateikimas:	01/09/2018
Numatytas registravimas pateiktas:	01/09/2018
Pirmas paskelbtas:	01/17/2018
Paskutinis atnaujinimas pateiktas:	06/30/2019
Paskutinis atnaujinimas paskelbtas:	07/01/2019
Faktinė studijų pradžios data:	12/31/2018
Numatoma pirminio užbaigimo data:	06/15/2019
Numatoma studijų užbaigimo data:	06/15/2019

Būklė ar liga

Gastric Bypass Surgery

Intervencija / gydymas

Radiation: Laser irradiation regimes

Fazė

Rankų grupės

Ranka	Intervencija / gydymas
Experimental: Laser irradiation regimes Non-ionising radiation intervention will be applied to skin explants	Radiation: Laser irradiation regimes Laser regimes will be applied to ex vivo skin samples.

Tinkamumo kriterijai

Amžius, tinkami studijuoti	18 Years Į 18 Years
Tinkamos studijoms lytys	All
Priima sveikus savanorius	Taip
Kriterijai	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.

Rezultatas

Pirminės rezultatų priemonės

1. Thermal damage threshold [Within 3 months]

Quantitative evaluation of laser induced damage by histological lesion in epidermis and dermis.