Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage | NCT03402347

Studies
Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage

NCT03402347

Sponsor

RSP Systems A/S

Status

Completed

Last Update Posted

Jul 2, 2019Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Gastric Bypass Surgery

Interventions

Non-ionising radiation

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jun 16, 2019Actual

Completion Date

Jun 16, 2019Actual

First Submitted Date

Jan 10, 2018

First Submission Date that Met QC Criteria

Jan 10, 2018

First Posted Date

Jan 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2019

Last Update Posted Date

Jul 2, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laser irradiation regimes	Experimental	Non-ionising radiation intervention will be applied to skin explants	Radiation: Non-ionising radiation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-ionising radiation	Radiation	Laser regimes will be applied to ex vivo skin samples.	Laser irradiation regimes

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens Ahm Sørensen, MD	Department of plastic surgery Z OUH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of plastic surgery Z OUH		Odense		5000	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011840	Radiation, Nonionizing

Ancestor Terms

ID	Term
D011827	Radiation
D055585	Physical Phenomena

Browse Leaves

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Browse Branches

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