Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage

Gastric Bypass Surgery Clinical Trial

Official title:

Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03402347
• Other study ID #: RSP-11
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: June 16, 2019

Study information

• Verified date: July 2019
• Source: RSP Systems A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: June 16, 2019
• Est. primary completion date: June 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Bypass Surgery

Intervention

Radiation:
• Non-ionising radiation
Laser regimes will be applied to ex vivo skin samples.

Locations

Country	Name	City	State
Denmark	Department of plastic surgery Z OUH	Odense

Sponsors (1)

Lead Sponsor	Collaborator
RSP Systems A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thermal damage threshold	Quantitative evaluation of laser induced damage by histological lesion in epidermis and dermis.	Within 3 months