Hyperspectral imaging for contactless diagnosis and differentiation of chronic inflammatory diseases, intraepithelial or invasive neoplasms in the cervix and vulva.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039103

Enrollment

200

Registered

2026-02-03

Start date

2024-10-01

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic inflammatory diseases, intraepithelial or invasive neoplasms in the cervix and vulva N76 N87 C51 C52 C53 N72

Interventions

Group 1: Diagnostic procedure (non-invasive imaging): Hyperspectral imaging (HSI) using HSI MIS system (combination of TIVITA® tissue camera and endoscope) Group 2: Healthy tissue areas from the same

comparison with standard diagnostics (colposcopy/vulvoscopy)

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Clinical/histological evidence of an inflammatory lesion or intraepithelial or invasive neoplasia in the cervix or vulva. • Written informed consent

Exclusion criteria

Exclusion criteria: • lack of patient consent

Design outcomes

Primary

Measure	Time frame
Determination of the sensitivity and specificity of hyperspectral imaging (HSI MIS) for differentiating between inflammatory, intraepithelial, and invasive neoplasms of the cervix and vulva. HSI MIS (index test) is performed prospectively as part of colposcopy/vulvoscopy or preoperatively before tissue sampling and compared with histopathological examination as the reference standard. Statistical analysis is performed retrospectively after the final histological findings are available.	—

Measure

Time frame

Determination of the sensitivity and specificity of hyperspectral imaging (HSI MIS) for differentiating between inflammatory, intraepithelial, and invasive neoplasms of the cervix and vulva. HSI MIS (index test) is performed prospectively as part of colposcopy/vulvoscopy or preoperatively before tissue sampling and compared with histopathological examination as the reference standard. Statistical analysis is performed retrospectively after the final histological findings are available.

—

Secondary

Measure	Time frame
Usability: Medical evaluation of the practical applicability of HSI MIS in everyday clinical practice. Diagnostic accuracy: Comparison of the sensitivity and specificity of HSI MIS with conventional colposcopy/vulvoscopy. Combined diagnostics: Analysis of the improvement in sensitivity and specificity through the combination of colposcopy/vulvoscopy and HSI MIS.	—

Countries

Germany

Contacts

Public ContactMartin Weiss

Department für Frauengesundheit am Universitätsklinikum Tübingen

Martin.Weiss@med.uni-tuebingen.de+497071 2982211

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026