Moletest Clinical Study in Scotland

Melanoma Clinical Trial

Official title:

A Clinical Study to Evaluate the Ability of an iPad Based Photographic Image Analysis System to Discriminate Benign Skin Lesions From Those Considered Suspect for Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196246
• Other study ID #: Protocol-004
• Status: Completed
• Phase: N/A
• First received: July 17, 2014
• Last updated: December 1, 2017
• Start date: March 27, 2015
• Est. completion date: May 31, 2017

Study information

• Verified date: December 2017
• Source: Moletest Scotland Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate an iPad based photoimage analysis system (Moletest) for improving discrimination of benign from malignant suspicious skin lesions or moles. Specifically the objective is to demonstrate that the Moletest system is able with a sufficient degree of confidence (95%) to identify lesions which are benign

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1120
• Est. completion date: May 31, 2017
• Est. primary completion date: October 12, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

All patients referred to the Dermatology Department, Lanarkshire Hospitals during a period to be defined for assessment of suspicious skin lesions (cutaneous moles) will be eligible for inclusion in the study. There are no age limits but patients under the age of 18 years will also have their inclusion subject to parental/guardian consent

Exclusion Criteria:

There is no exclsion criteria

Related Conditions & MeSH terms

• Melanoma

Locations

Country	Name	City	State
United Kingdom	NHS Lanarkshire R&D	Airdrie

Sponsors (3)

Lead Sponsor	Collaborator
Moletest Scotland Ltd	Digital Health & Care Institute, NHS Lanarkshire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical accuracy of Moletest application, the combined measured attributes of a suspect legion compared to the outcome of a biopsy performed on the legion	The image and analysis by the application are performed within 10 minutes of the patient giving consent to be part of this study. The biopsy that will be used for comarison with the image analysis will be available to the Investigators approximatly 6 weeks later	6 weeks turnaround for each sample

External Links

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