Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage

July 1, 2019 updated by: RSP Systems A/S
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Department of plastic surgery Z OUH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser irradiation regimes
Non-ionising radiation intervention will be applied to skin explants
Radiation: Non-ionising radiation
Laser regimes will be applied to ex vivo skin samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thermal damage threshold
Time Frame: Within 3 months
Quantitative evaluation of laser induced damage by histological lesion in epidermis and dermis.
Within 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RSP Systems A/S

Investigators

  • Principal Investigator: Jens Ahm Sørensen, MD, Department of plastic surgery Z OUH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

June 16, 2019

Study Completion (Actual)

June 16, 2019

Study Registration Dates

First Submitted

January 10, 2018

First Submitted That Met QC Criteria

January 10, 2018

First Posted (Actual)

January 18, 2018

Study Record Updates

Last Update Posted (Actual)

July 2, 2019

Last Update Submitted That Met QC Criteria

July 1, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RSP-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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