WoundEquivalenceNCT03754426
A Prospective, Pilot Evaluation of Device Equivalence
An observational study of Wound, run by MolecuLight Inc. at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound
- What is being tested?
- Fluorescence Imaging Device
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 26 Nov 2018to 2 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with chronic wounds
Who may be able to join
- Subjects (inpatient/outpatient) presenting with a wound
- Wound size less than 15 cm in length
- 18 years or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Judy Dan Research and Treatment Centre
North York, Ontario, M2R 1N5
About this study
Official title: Validation of MolecuLight Phoenix Prototypes in Clinic
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.
Read the 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.
- Conditions
- Wound
- Being tested
- Fluorescence Imaging Device
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence Imaging DeviceDevice
Hand-held, real-time fluorescence imaging device
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance
Estimate concordance of moderate/heavy bacterial load present in images acquired with each of 3 devices
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start26 Nov 2018
- Primary completion2 Jan 2019
- Study completion2 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- MolecuLight Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron Linden, MD, Principal investigator, Judy Dan Research and Treatment Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754426
- Sponsor's protocol ID
- 18-009
- Acronym
- Equivalence
- Status last verified
- Nov 2019
- First submitted
- 22 Nov 2018
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of MolecuLight Phoenix Prototypes in Clinic
- ClinicalTrials.gov ID
- NCT03754426
- Acronym / sponsor ID
- Equivalence / 18-009
- Conditions
- Wound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- MolecuLight Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 2 Jan 2019 (actual)
- Study completion
- 2 Jan 2019 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic wounds
Key inclusion criteria (3 listed)
- Subjects (inpatient/outpatient) presenting with a wound
- Wound size less than 15 cm in length
- 18 years or older
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorescence Imaging DeviceHand-held, real-time fluorescence imaging device | Device | – |
Primary outcome
Concordance
Time frame: 2 months
Estimate concordance of moderate/heavy bacterial load present in images acquired with each of 3 devices
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Linden, MD principal investigator
Judy Dan Research and Treatment Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound, run by MolecuLight Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.