Trial Outcomes & Findings for Evaluation of Pigmented Skin Lesions With MelaFind(R) System (NCT NCT00434057)

Results Overview

Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1383 participants

Primary outcome timeframe

Within 120 days of Data Lock

Results posted on

2012-02-14

Participant Flow

Participant milestones

Participant milestones
Measure	Biopsied Pigmented Skin Lesions Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
Overall Study STARTED	1383
Overall Study COMPLETED	1382
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Biopsied Pigmented Skin Lesions Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Evaluation of Pigmented Skin Lesions With MelaFind(R) System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Biopsied Pigmented Skin Lesions n=1383 Participants Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
Age, Categorical <=18 years	56 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1056 Participants n=5 Participants
Age, Categorical >=65 years	271 Participants n=5 Participants
Age Continuous	48 years STANDARD_DEVIATION 18.3 • n=5 Participants
Sex: Female, Male Female	745 Participants n=5 Participants
Sex: Female, Male Male	638 Participants n=5 Participants
Region of Enrollment United States	1383 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 120 days of Data Lock

Population: All participants with eligible and evaluable lesions were used in analysis of primary outcome measures

Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma.

Outcome measures

Outcome measures
Measure	Biopsied Pigmented Skin Lesions n=1257 Participants Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
Sensitivity and Specificity MelaFind sensitivity to melanoma	98.2 Ratio * 100 Interval 95.1 to 100.0
Sensitivity and Specificity MelaFind specificity for melanoma	9.5 Ratio * 100 Interval 6.1 to 12.9

SECONDARY outcome

Timeframe: Within 120 days of Data Lock

Number of lesions bioopsied to melanomas detected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 365 days of Data Lock

Outcome measures

Outcome data not reported

Adverse Events

Biopsied Pigmented Skin Lesions

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joanna Adrian / Director, Clinical Operations and Medical Affairs

Electro-Optical Sciences, Inc.

Phone: (914)591-3783

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60