Acute Kidney InjuryNCT03810833
Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System
A study testing Brilliance device sensor in people with Acute Kidney Injury, run by MediBeacon at 1 site in United States.
Trial summary
This study is designed to evaluate background fluorescence of participants of different ages, gender, and skin color. In addition, 48-hour tolerability of the sensor and adhesive will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Brilliance device sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2019to 23 Sep 2019
- Phase
- Interventional
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female adults age 18 and older
- 2 age cohorts to be recruited: 18 - 50 years of age and 51+ years or older
- Skin color groups to be recruited in accordance with the Fitzpatrick Skin Scale (I - VI)
- Participants willing to sign the Institutional Review Board (IRB) approved informed consent form prior to the initiation of any study specific procedures.
Who cannot join
- History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
- Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial
- Significant scarring, tattoos or alterations in pigmentation on the standardized sensor locations that would alter sensor readings versus other areas of the skin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System
This study is designed to evaluate background fluorescence of participants of different ages, gender, and skin color. In addition, 48-hour tolerability of the sensor and adhesive will be evaluated.
Read the detailed description
The MediBeacon Transdermal GFR Measurement System investigational is intended to measure the Glomerular Filtration Rate (GFR) in patients with normal or impaired renal function by noninvasively monitoring fluorescent light emission from an exogenous tracer agent (MB-102) over time. The device utilized in this study is the Brilliance device. Approximately 1 male and 1 female from each age cohort (18-50 years; 51+ years) and clustered Fitzpatrick Skin Scale groups (I-II [Light, pale white; white, fair]; III-IV [Medium, white to olive; olive, moderate brown]; and V-VI [Brown, dark brown; black, very dark brown to black]) will be recruited, for a total of 12 participants. Participants will have Brilliance device sensors placed on two locations on their skin, which will remain for 48 hours. The sensor location will be prepared through shaving and cleaning (as applicable), placed on the skin via standard single-use adhesive pads, and baseline measurements collected. Participants may undergo activities of daily living while measurements are being collected. Light pressure and other minor perturbations may be applied to the sensors to evaluate the effect on background fluorescence. Adverse events associated with sensor placement (such as skin irritations) will be recorded.
- Conditions
- Acute Kidney Injury
- Being tested
- Brilliance device sensor
- Keywords
- Glomerular Filtration Rate
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brilliance device sensorDevice
Two separate sensors will be attached via standard, single-use adhesive pads to the left and right pectoralis major on each participant.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Brilliance sensor placement | Experimental | Brilliance device sensors placed on the left and right pectoralis major, remaining for 48 hours Receives: Device: Brilliance device sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Background Fluorescence
Two separate Brilliance device sensors will be attached via standard adhesive pads to the left and right pectoralis major on each participant. Fluorescence measurements will be collected directly by the MediBeacon Transdermal GFR Measurement System Brilliance device, and will be continuously collected throughout the 48 hour study.
Measured: From the time of sensor placement to 48 hours after placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start16 Sep 2019
- Primary completion23 Sep 2019
- Study completion23 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediBeacon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard B Dorshow, PhD, Study director, MediBeacon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810833
- Sponsor's protocol ID
- ORFM Sensor 100-01
- Status last verified
- Jan 2020
- First submitted
- 17 Jan 2019
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System
- ClinicalTrials.gov ID
- NCT03810833
- Acronym / sponsor ID
- ORFM Sensor 100-01
- Conditions
- Acute Kidney Injury
- Keywords
- Glomerular Filtration Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- MediBeaconIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 23 Sep 2019 (actual)
- First posted
- 22 Jan 2019 (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.
This study is designed to evaluate background fluorescence of participants of different ages, gender, and skin color. In addition, 48-hour tolerability of the sensor and adhesive will be evaluated.
Detailed description
The MediBeacon Transdermal GFR Measurement System investigational is intended to measure the Glomerular Filtration Rate (GFR) in patients with normal or impaired renal function by noninvasively monitoring fluorescent light emission from an exogenous tracer agent (MB-102) over time. The device utilized in this study is the Brilliance device. Approximately 1 male and 1 female from each age cohort (18-50 years; 51+ years) and clustered Fitzpatrick Skin Scale groups (I-II [Light, pale white; white, fair]; III-IV [Medium, white to olive; olive, moderate brown]; and V-VI [Brown, dark brown; black, very dark brown to black]) will be recruited, for a total of 12 participants. Participants will have Brilliance device sensors placed on two locations on their skin, which will remain for 48 hours. The sensor location will be prepared through shaving and cleaning (as applicable), placed on the skin via standard single-use adhesive pads, and baseline measurements collected. Participants may undergo activities of daily living while measurements are being collected. Light pressure and other minor perturbations may be applied to the sensors to evaluate the effect on background fluorescence. Adverse events associated with sensor placement (such as skin irritations) will be recorded.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Brilliance sensor placement | Experimental | Device: Brilliance device sensorBrilliance device sensors placed on the left and right pectoralis major, remaining for 48 hours |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male and female adults age 18 and older
- 2 age cohorts to be recruited: 18 - 50 years of age and 51+ years or older
- Skin color groups to be recruited in accordance with the Fitzpatrick Skin Scale (I - VI)
- Participants willing to sign the Institutional Review Board (IRB) approved informed consent form prior to the initiation of any study specific procedures.
Key exclusion criteria (3 listed)
- History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
- Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial
- Significant scarring, tattoos or alterations in pigmentation on the standardized sensor locations that would alter sensor readings versus other areas of the skin
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 |
|---|---|---|
| Brilliance device sensorTwo separate sensors will be attached via standard, single-use adhesive pads to the left and right pectoralis major on each participant. | Device | Participants with Brilliance sensor placement |
Primary outcome
Mean Background Fluorescence
Time frame: From the time of sensor placement to 48 hours after placement
Two separate Brilliance device sensors will be attached via standard adhesive pads to the left and right pectoralis major on each participant. Fluorescence measurements will be collected directly by the MediBeacon Transdermal GFR Measurement System Brilliance device, and will be continuously collected throughout the 48 hour study.
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 10 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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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.
Richard B Dorshow, PhD study director
MediBeacon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brilliance device sensor in people with Acute Kidney Injury, run by MediBeacon at 1 site in United States.
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 4 inclusion and 3 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 10 Jan 2020. 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 United States. 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?
Mean Background Fluorescence (time frame: From the time of sensor placement to 48 hours after placement). 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 10 Jan 2020.