Focus of Study: Patients With Suspicion of MelanomaNCT04161742
Clinical Utility of Electrical Impedance Spectroscopy
A study testing Nevisense in people with Focus of Study: Patients With Suspicion of Melanoma, run by SciBase AB.
Trial summary
The purpose of this clinical study is to evaluate the clinical utility of the Nevisense in normal clinical practice, i.e. the potential effect of implementing Nevisense in clinical decision making (Human vs Human \& Machine) based on Nevisense measurement at time of biopsy decision. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Focus of Study: Patients With Suspicion of Melanoma
- What is being tested?
- Nevisense
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Aug 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The lesion(s) meet criteria for Nevisense evaluation.
- Lesions that present with unclear clinical presentation to allow for clinical diagnosis of benign or minimally dysplastic nevus (nevi) -Thus, necessitating a biopsy.
- Lesions within Nevisense indication for use: Nevisense is indicated for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma, when a dermatologist chooses to obtain additional information when considering biopsy. Nevisense should not be used on clinically obvious melanoma. The Nevisense result is one element of the overall clinical assessment. The output of Nevisense should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to biopsy. Nevisense is indicated only for use on:
- primary skin lesions with a diameter between 2 mm and 20 mm;
- lesions that are accessible by the Nevisense probe;
- lesions where the skin is intact (i.e. non-ulcerated or non-bleeding lesions);
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- lesions that do not contain a scar or fibrosis consistent with previous trauma;
- lesions not located in areas of psoriasis, eczema, acute sunburn or similar skin conditions;
- lesions not in hair-covered areas;
- lesions which do not contain foreign matter;
- lesions not on special anatomic sites (i.e. not for use on acral skin, genitalia, eyes, mucosal areas).
Who cannot join
- Subjects who fail to provide informed consent
- Study subjects with underlying medical disease which may alter ability to diagnose clinically or inhibit Nevisense from collecting data
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Clinical Utility of Electrical Impedance Spectroscopy in Normal Clinical Practice at Hospital Setting
The purpose of this clinical study is to evaluate the clinical utility of the Nevisense in normal clinical practice, i.e. the potential effect of implementing Nevisense in clinical decision making (Human vs Human \& Machine) based on Nevisense measurement at time of biopsy decision.
Read the detailed description
This is a multi-center, prospective, blinded clinical study designed to evaluate clinical utility of Nevisense in normal clinical practice, i.e. the potential effect of implementing Nevisense in clinical decision making (Human vs Human \& Machine) based on Nevisense measurement after biopsy decision. The study enrollment will continue until minimum of 180 subjects are enrolled in the study. Up to 3 US university/hospital investigational sites will participate in this study. Biopsying clinician or the investigators from the clinical practices of physicians participating in the study will perform the patient and lesion assessment for biopsy as standard of care at the clinic.
Study subjects will be recruited from the clinical practices of physicians participating as investigators in this study. Biopsying clinicians provide their assessment to whether s/he would have sent the lesion(s) for biopsy had s/he known the EIS information beforehand . Thereafter an evaluation of the suspicious lesion with the Nevisense will be performed followed by a biopsy of the lesion. The biopsied lesion will be subjected to histological analysis.
- Being tested
- Nevisense
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevisenseDevice
Nevisense measures electrical impedance of skin lesions and provides an output called the electrical impedance spectroscopy (EIS) score
What is being measured
The primary outcome is the main question the study is designed to answer.
Number needed to biopsy
The primary study outcome is the number needed to biopsy to detect a single melanoma case.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study startDec 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Focus of Study: Patients With Suspicion of MelanomaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SciBase AB
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Ferris, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161742
- Sponsor's protocol ID
- FG-001
- Status last verified
- Nov 2019
- First submitted
- 5 Nov 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malvehy J, Hauschild A, Curiel-Lewandrowski C, Mohr P, Hofmann-Wellenhof R, Motley R, Berking C, Grossman D, Paoli J, Loquai C, Olah J, Reinhold U, Wenger H, Dirschka T, Davis S, Henderson C, Rabinovitz H, Welzel J, Schadendorf D, Birgersson U. Clinical performance of the Nevisense system in cutaneous melanoma detection: an international, multicentre, prospective and blinded clinical trial on efficacy and safety. Br J Dermatol. 2014 Nov;171(5):1099-107. doi: 10.1111/bjd.13121. Epub 2014 Oct 19.
PubMed 24841846Rocha L, Menzies SW, Lo S, Avramidis M, Khoury R, Jackett L, Guitera P. Analysis of an electrical impedance spectroscopy system in short-term digital dermoscopy imaging of melanocytic lesions. Br J Dermatol. 2017 Nov;177(5):1432-1438. doi: 10.1111/bjd.15595. Epub 2017 Oct 11.
PubMed 28421597
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Utility of Electrical Impedance Spectroscopy in Normal Clinical Practice at Hospital Setting
- ClinicalTrials.gov ID
- NCT04161742
- Acronym / sponsor ID
- FG-001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- SciBase ABUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 13 Nov 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.
The purpose of this clinical study is to evaluate the clinical utility of the Nevisense in normal clinical practice, i.e. the potential effect of implementing Nevisense in clinical decision making (Human vs Human \& Machine) based on Nevisense measurement at time of biopsy decision.
Detailed description
This is a multi-center, prospective, blinded clinical study designed to evaluate clinical utility of Nevisense in normal clinical practice, i.e. the potential effect of implementing Nevisense in clinical decision making (Human vs Human \& Machine) based on Nevisense measurement after biopsy decision. The study enrollment will continue until minimum of 180 subjects are enrolled in the study. Up to 3 US university/hospital investigational sites will participate in this study. Biopsying clinician or the investigators from the clinical practices of physicians participating in the study will perform the patient and lesion assessment for biopsy as standard of care at the clinic.
Study subjects will be recruited from the clinical practices of physicians participating as investigators in this study. Biopsying clinicians provide their assessment to whether s/he would have sent the lesion(s) for biopsy had s/he known the EIS information beforehand . Thereafter an evaluation of the suspicious lesion with the Nevisense will be performed followed by a biopsy of the lesion. The biopsied lesion will be subjected to histological analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- The lesion(s) meet criteria for Nevisense evaluation.
- Lesions that present with unclear clinical presentation to allow for clinical diagnosis of benign or minimally dysplastic nevus (nevi) -Thus, necessitating a biopsy.
- Lesions within Nevisense indication for use: Nevisense is indicated for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma, when a dermatologist chooses to obtain additional information when considering biopsy. Nevisense should not be used on clinically obvious melanoma. The Nevisense result is one element of the overall clinical assessment. The output of Nevisense should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to biopsy. Nevisense is indicated only for use on:
Key exclusion criteria (2 listed)
- Subjects who fail to provide informed consent
- Study subjects with underlying medical disease which may alter ability to diagnose clinically or inhibit Nevisense from collecting data
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 |
|---|---|---|
| NevisenseNevisense measures electrical impedance of skin lesions and provides an output called the electrical impedance spectroscopy (EIS) score | Device | – |
Primary outcome
Number needed to biopsy
Time frame: 1 day
The primary study outcome is the number needed to biopsy to detect a single melanoma case.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Background: PubMed 24841846Malvehy J, Hauschild A, Curiel-Lewandrowski C, Mohr P, Hofmann-Wellenhof R, Motley R, Berking C, Grossman D, Paoli J, Loquai C, Olah J, Reinhold U, Wenger H, Dirschka T, Davis S, Henderson C, Rabinovitz H, Welzel J, Schadendorf D, Birgersson U. Clinical performance of the Nevisense system in cutaneous melanoma detection: an international, multicentre, prospective and blinded clinical trial on efficacy and safety. Br J Dermatol. 2014 Nov;171(5):1099-107. doi: 10.1111/bjd.13121. Epub 2014 Oct 19.
- Background: PubMed 28421597Rocha L, Menzies SW, Lo S, Avramidis M, Khoury R, Jackett L, Guitera P. Analysis of an electrical impedance spectroscopy system in short-term digital dermoscopy imaging of melanocytic lesions. Br J Dermatol. 2017 Nov;177(5):1432-1438. doi: 10.1111/bjd.15595. Epub 2017 Oct 11.
- Individual participant dataSharing planned: No
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.
Laura Ferris, MD principal investigator
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
A study testing Nevisense in people with Focus of Study: Patients With Suspicion of Melanoma, run by SciBase AB.
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 11 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Ferris, MD (+1 412-647-4200, ferrlk@UPMC.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number needed to biopsy (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04161742, which also lists 2 linked publications.
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 13 Nov 2019.