A Prospective, Pilot Evaluation of Device Equivalence | NCT03754426

Studies
A Prospective, Pilot Evaluation of Device Equivalence

NCT03754426

Sponsor

MolecuLight Inc.

Status

Completed

Last Update Posted

Dec 3, 2019Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Wound

Interventions

Fluorescence Imaging Device

Countries

Canada

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

Nov 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

Nov 26, 2018Actual

Primary Completion Date

Jan 2, 2019Actual

Completion Date

Jan 2, 2019Actual

First Submitted Date

Nov 22, 2018

First Submission Date that Met QC Criteria

Nov 22, 2018

First Posted Date

Nov 27, 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

Nov 29, 2019

Last Update Posted Date

Dec 3, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients with chronic wounds will be imaged using 3 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 3 imaging devices will be compared off-line by 5 interpreters to assess for any differences in the images that would alter a clinical decision.

Detailed Description

Patients (n = 50) with chronic wounds will be imaged using 3 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 3 imaging devices will be compared off-line by 5 interpreters to assess for any differences in the images that would alter a clinical decision.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluorescence Imaging Device	Device	Hand-held, real-time fluorescence imaging device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concordance	Estimate concordance of moderate/heavy bacterial load present in images acquired with each of 3 devices	2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects (inpatient/outpatient) presenting with a wound
Wound size less than 15 cm in length
18 years or older

Exclusion Criteria:

Treatment with an investigational drug within 1 month before study enrolment
Subjects with recent (<30 days) biopsy or curettage of target wound
Subjects with wounds that cannot be completely imaged by study device due to anatomic location
Unable or unwilling to consent

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

patients with chronic wounds

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ron Linden, MD	Judy Dan Research and Treatment Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Judy Dan Research and Treatment Centre		North York	Ontario	M2R 1N5	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

There is no plan to disseminate information to patients. If patients ask for their information then they will be provided a response with the most up to date information.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided