Non-Linear Imaging of Skin In Vivo

• Sponsor: Enspectra Health (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05410964
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 20.2

Study Details

Study Description

Brief Summary

The overall objective of this study is to investigate the potential for Enspectra Investigational Device to display microscopic skin structure in people of different age, sex, race, and skin health.

Condition or Disease	Intervention/Treatment	Phase
Skin Cancer	Device: Vio

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Non-Linear Imaging of Skin In Vivo
• Actual Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Aug 30, 2022
• Anticipated Study Completion Date: Aug 30, 2022

Outcome Measures

Primary Outcome Measures

1. Imaging Performance [1 hour]

   Quantify imaging performance in various types of skin, which may include estimated in vivo resolution and imaging depth. Various types of skin includes skin of different people as well as skin in different locations on the body, and skin with skin disease, including basal cell carcinoma

2. Image Quality [1 hour]

   Qualitatively evaluate image quality and interpretability by physicians trained in dermatopathology as a function of skin type.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Subjects, ages 2 - 90 years old.

2. Subject, or guardian, if applicable, must be willing to provide written informed consent prior to enrollment and agree to comply with protocol requirements. If applicable, child must be willing to provide written assent prior to enrollment and agree to comply with protocol requirements.

3. Subject or guardian, if applicable, must have sufficient mental capacity to understand the Informed Consent and provide clinically relevant and reliable feedback regarding their experience with the device.

4. Subject and guardian, if applicable, must comply with the protocol requirements.

5. Subject or guardian, if applicable, must agree that anonymized personal data will be made available to Study Sponsor and requisite regional and international regulatory bodies.

Exclusion Criteria:

1. Any general health condition or systemic disease that may represent, in the opinion of the Principal Investigator, a potential increased risk associated with device use

2. Currently infected with a communicable skin infection (e.g., shingles or methicillin-resistant S. aureus), which does not include local and minimally pathogenic or non-pathogenic infections distant from the imaging location(s) (e.g., warts, acne)

3. Any known allergies to any materials used in the preparation of skin and/or device use

4. Has a temporary or permanent electrical implanted medical device

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Enspectra Health	Mountain View	California	United States	94040

Sponsors and Collaborators

• Enspectra Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Enspectra Health
• ClinicalTrials.gov Identifier: NCT05410964
• Other Study ID Numbers: CR 30062
• First Posted: Jun 8, 2022
• Last Update Posted: Jul 26, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Skin Neoplasms

Study Results

No Results Posted as of Jul 26, 2022