Early Detection of Pressure Induced Tissue Damage by Infr... | NCT03518190

Studies
Early Detection of Pressure Induced Tissue Damage by Infrared Spectroscopy (ODP) Device

NCT03518190

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Apr 28, 2022Actual

Enrollment

31Actual

Phase

Not Applicable

Conditions

Pressure Ulcer Not Visible

Interventions

Infrared spectroscopy (ODP)

Countries

Israel

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

Apr 2022

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

Jul 30, 2018Actual

Primary Completion Date

May 12, 2021Actual

Completion Date

May 12, 2021Actual

First Submitted Date

Apr 25, 2018

First Submission Date that Met QC Criteria

Apr 25, 2018

First Posted Date

May 8, 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

Apr 27, 2022

Last Update Posted Date

Apr 28, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yehuda Ullmann MD, Head of Plastic Surgery Department, Rambam Health Care CampusPrincipal Investigator

Lead Sponsor

Rambam Health Care CampusOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The aim of this study is to demonstrate that infrared spectroscopy is able to detect pressure injuries at a very early stage

Detailed Description

During pressure injuries formation early sub dermal bio signal appear. By applying infrared spectroscopy at a suspicions injury site on the human body and obtaining a reflected infrared light infrared allows to determine early formation of a pressure injury/

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

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Suspected pressure injury	Experimental	Patients evaluated with high-risk for pressure injury	Device: Infrared spectroscopy (ODP)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Infrared spectroscopy (ODP)	Device	Infrared spectroscopy device will be used to detect non-visible pressure injuries	Suspected pressure injury

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Early detection of pressure induced tissue damage	Infrared spectroscopy will indicate on a system-defined scale (yes/no) whether or not the subject has a pressure injury	Ten minutes
Pressure injury probability	Infrared spectroscopy will calculate using accepted statistical tools the probability of the subject getting a pressure injury within the next few days	Ten minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with stage 1 pressure injury
Patients with high risk of developing pressure injury

Exclusion Criteria:

Patients with stage 2 pressure injury or higher

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam healrh care campus		Haifa			Israel

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