DermaSensor Postmarket Surveillance Study

Conditions

• Melanoma, Skin

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Scan with elastic scattering spectroscopy device to assess risk of malignancy — DEVICE
  Elastic scattering spectroscopy device uses a spectrum of light reflectance to compare suspicious lesion signature to that of previously scanned lesions with known benign or malignant pathology

Study Details

The objective of this study is to evaluate the sensitivity of the DermaSensor device and Investigators when used on skin lesions concerning for melanoma.

Key Dates

Start date

Oct 8, 2024

Status verified

Oct 2024

Primary completion

Apr 11, 2027

Completion

Sep 10, 2027

Study Design

Enrollment

396 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

SCREENING

Arms

• No Intervention: Clinical assessment only
  Lesions assessed as clinically suspicious by primary care investigator who make diagnostic and management decision to biopsy without ESS device output
• Experimental: Clinical assessment with device output
  Lesions assessed as clinically suspicious by primary care investigator who make diagnostic and management decision to biopsy with ESS device output

Primary Outcome Measure

Device Sensitivity [ Time Frame: 39 months ]

Central Contacts

• Justin Frazier, MS
  508-776-0044
  [email protected]

Locations (2)

Find similar trials in New Smyrna Beach, FL