Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala

Ingia / Ingia

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HaliImekamilika

Wadhamini

RSP Systems A/S

JARIBIO LA KLINIKI: NCT03402347

BioSeek: nct03402347

Maneno muhimu

homa

Kikemikali

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.

Maelezo

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.

Tarehe

Imethibitishwa Mwisho:	06/30/2019
Iliyowasilishwa Kwanza:	01/09/2018
Uandikishaji uliokadiriwa Uliwasilishwa:	01/09/2018
Iliyotumwa Kwanza:	01/17/2018
Sasisho la Mwisho Liliwasilishwa:	06/30/2019
Sasisho la Mwisho Lilichapishwa:	07/01/2019
Tarehe halisi ya kuanza kwa masomo:	12/31/2018
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	06/15/2019
Tarehe ya Kukamilisha Utafiti:	06/15/2019

Hali au ugonjwa

Gastric Bypass Surgery

Uingiliaji / matibabu

Radiation: Laser irradiation regimes

Awamu

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
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.

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza	18 Years Kwa 18 Years
Jinsia Inastahiki Kujifunza	All
Hupokea Wajitolea wa Afya	Ndio
Vigezo	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.

Matokeo

Hatua za Matokeo ya Msingi

1. Thermal damage threshold [Within 3 months]

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