NCT06793423Csak meghívásos
TruScore Standalone Clinical Study
Non-Significant Risk (NSR) Device Study to Evaluate Device Performance on Pigmented, Non-/Pigmented Skin Lesions and Histological Diagnoses: TruScore Standalone Clinical Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 27.
Rövid összefoglaló (regiszter, angolul)
The goal of this clinical trial is to evaluate if the TruScore device can accurately diagnose suspicious skin lesions in patients aged 22 years and older. The main questions it aims to answer are: Can the TruScore device accurately identify non-pigmented skin lesions suggestive of basal cell carcinoma and squamous cell carcinoma? Can the TruScore device accurately identify pigmented skin lesions suggestive of melanoma? Researchers will compare the device's performance on pigmented and non-pigmented lesions to see if it meets the sensitivity and specificity targets. Participants will: Have their suspicious skin lesions evaluated using the TruScore device. Undergo a biopsy of the evaluated lesions for comparison and confirmation by dermatopathologists. Provide demographic and medical history information. The TruScore device works by detecting and analyzing differences in blood flow between normal and malignant skin lesions. It uses a non-invasive, hand-held unit that applies slight pressure to the skin and uses light to measure these differences. The device then provides a recommendation on whether the lesion should be monitored or investigated further by a dermatologist. This study aims to improve the early detection of skin cancer by providing a reliable tool for non-specialist healthcare providers.
- Állapot (regiszter)
- Csak meghívásos
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 464 (tervezett)
- Első benyújtás
- 2025. jan. 12.
- Kezdés
- 2025. szept. 25.
- Elsődleges befejezés
- 2027. máj. 30.
- Fő szponzor
- VeriSkin, Inc.
- Betegségek
- Melanóma
- NCT-szám
- NCT06793423
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 464
- 2025. szept. 25. és az elsődleges befejezés (2027. máj. 30.) között
- 6 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- Previously Biopsied or Traumatized Areas: Lesions located in areas that have been previously biopsied, subjected to any kind of surgical intervention, or traumatized.
Más betegség
- Skin Conditions: Lesions located on areas with scars, crusts, psoriasis, eczema, dermatitis, or similar skin conditions that could influence blood flow where the lesion is located.
- Non-intact Skin: Skin in the measurement area that is not intact (e.g., bleeding or with clinically noticeable ulceration).
Egyéb
- Non-measurable Skin Surface: Lesions on skin surfaces that cannot be measured (e.g., lesions on a stalk).
- Inaccessible Skin Surface: Lesions on skin surfaces that are not accessible (e.g., inside ears, under nails).
- Specific Body Parts: Lesions located on the nose, lips, ears, or eyelids.
- Acral Skin: Lesions located on acral skin (e.g., soles of the feet, palms of the hands).
- Hair-covered Areas: Lesions on hair-covered areas (e.g., scalp, beards, mustaches) unless the lesion is not covered by hair.
- Genitalia: Lesions located on the genitalia.
- Mucosal Surfaces: Lesions located on mucosal surfaces.
- Foreign Matter: Lesions with foreign matter present (e.g., tattoos, splinters).
- Acute Sunburn: Lesions located on areas with acute sunburn.
- Collision Lesions: Lesions that are collision lesions (i.e., lesions that overlap or are adjacent to each other).
- Light Sensitivities: Patients with porphyria or other light sensitivities, such as phototoxicity or photoallergic reactions from antibiotics.
- Dermatologist-selected Lesions: Lesions that have been selected by a dermatologist.
Kiket keres a vizsgálat
- Age: Participants must be 22 years or older.
- Lesion Characteristics: Participants must have primary skin lesions (i.e., not metastases or recurrent lesions) that are identified as suspicious by the patient or chosen for biopsy by non-dermatologist clinicians.
- Lesion Size: The skin lesion must be 4 mm in diameter or greater.
- Multiple Lesions: If a participant has multiple skin lesions, all lesions to be biopsied will be identified as individual skin lesions for the study. A maximum of three skin lesions may be measured per participant.
- Informed Consent: Participants must be willing and able to read, comprehend, and sign the study-specific informed consent form.
Életkor a regiszterben: 22 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (6)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| VA Boston Healthcare System | Boston | Egyesült Államok | Ismeretlen állapot |
| John Hopkins Health Care & Surgery Center - Green Spring Station, Lutherville | Lutherville | Egyesült Államok | Ismeretlen állapot |
| Penn Dermatology | Philadelphia | Egyesült Államok | Ismeretlen állapot |
| Golden State Dermatology | Pleasanton | Egyesült Államok | Ismeretlen állapot |
| James A. Haley Veterans Hospital | Tampa | Egyesült Államok | Ismeretlen állapot |
| Golden State Dermatology | Walnut Creek | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.