Malignant MelanomaNCT00966173
International Melanoma Algorithm Training Study - IMATS
A study testing SciBase III Electrical Impedance Spectrometer in people with Malignant Melanoma, run by SciBase AB at 1 site in Sweden.
Trial summary
This is an international, multicenter, prospective, non controlled, non randomized, clinical study to collect electrical impedance data of potentially malignant pigmented nevi and histological diagnoses (International Melanoma Algorithm Training Study [IMATS]). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- SciBase III Electrical Impedance Spectrometer
- Type of treatment
- Medical device
- How many people
- 1,800 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2005to Jul 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women of any ethnic group
- Lesion located on normal healthy skin
- Maximum number of eight lesions per patient
- etc.
Who cannot join
- Lesion under finger and toe nails
- Lesion located on eczema, psoriasis areas or similar
- Lesion located on scars
- etc.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital, Dpt. of Dermatology
Gothenburg, 41345
About this study
Official title: An International, Multicenter, Prospective, Non-controlled, Non-randomised, Clinical Study to Collect Impedance Data of Potentially Malignant Pigmented Nevi and Histological Diagnoses
This is an international, multicenter, prospective, non controlled, non randomized, clinical study to collect electrical impedance data of potentially malignant pigmented nevi and histological diagnoses (International Melanoma Algorithm Training Study [IMATS]). The study objective is to collect data for training and optimization of an algorithm that can classify skin lesions using electrical impedance, i.e., to identify malignant melanomas.
- Conditions
- Malignant Melanoma
- Being tested
- SciBase III Electrical Impedance Spectrometer
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SciBase III Electrical Impedance SpectrometerDevice
Following enrollment, patients will undergo measurements with SciBase III Electrical Impedance Spectrometer. Electrical impedance of the skin will be measured with a microinvasive spiked probe.
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome measure not applicable. This is an algorithm training study.
Measured: Q1 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startDec 2005
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SciBase AB
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966173
- Sponsor's protocol ID
- 6001
- Status last verified
- Aug 2010
- First submitted
- 25 Aug 2009
- Last updated
- 11 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multicenter, Prospective, Non-controlled, Non-randomised, Clinical Study to Collect Impedance Data of Potentially Malignant Pigmented Nevi and Histological Diagnoses
- ClinicalTrials.gov ID
- NCT00966173
- Acronym / sponsor ID
- 6001
- Conditions
- Malignant Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- SciBase ABUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 26 Aug 2009 (estimated)
- 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 is an international, multicenter, prospective, non controlled, non randomized, clinical study to collect electrical impedance data of potentially malignant pigmented nevi and histological diagnoses (International Melanoma Algorithm Training Study [IMATS]). The study objective is to collect data for training and optimization of an algorithm that can classify skin lesions using electrical impedance, i.e., to identify malignant melanomas.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women of any ethnic group
- Lesion located on normal healthy skin
- Maximum number of eight lesions per patient
- etc.
Key exclusion criteria (4 listed)
- Lesion under finger and toe nails
- Lesion located on eczema, psoriasis areas or similar
- Lesion located on scars
- etc.
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 |
|---|---|---|
| SciBase III Electrical Impedance SpectrometerFollowing enrollment, patients will undergo measurements with SciBase III Electrical Impedance Spectrometer. Electrical impedance of the skin will be measured with a microinvasive spiked probe. | Device | – |
Primary outcome
Outcome measure not applicable. This is an algorithm training study.
Time frame: Q1 2010
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 11 Aug 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SciBase III Electrical Impedance Spectrometer in people with Malignant Melanoma, run by SciBase AB at 1 site in Sweden.
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 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 11 Aug 2010. 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 Sweden. 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?
Outcome measure not applicable. This is an algorithm training study. (time frame: Q1 2010). 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 11 Aug 2010.