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Proof-of-principle study evaluating hyperspectral imaging for non-invasive transdermal measurement of secondary tissue edema

Proof-of-principle study evaluating hyperspectral imaging for non-invasive transdermal measurement of secondary tissue edema - SenoEx_Hyperspektral_Gewebeoedem

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00027366
Enrollment
60
Registered
2021-12-08
Start date
2021-11-12
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Patients with symptomatic or asymptomatic secondary lymphedema e.g. after surgical treatment (e.g. tumor resection, mastectomy +/- axillary dissection, +/- radiotherapy, +/- chemotherapy, scar release, autologous breast tissue reconstruction). I97.2 I97.8

Interventions

Group 1: patients with proven tissue edema Study visits include: Review of inclusion and exclusion criteria
Oral and written informed consent and obtaining written informed consent and privacy policy
Demographic / medical history collection (age, health and nutritional status, weight, medical history)
Physical examination
Collection of standardized quality-of-life questionnaires
Examinations include: - Non-invasive instrumental examinations o Measurement of circumferential dimensions with a tape measure o Examination of sensibility by means of two-point discrimination o Exam

Sponsors

Universitätsklinikum Tübingen
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients with symptomatic or asymptomatic secondary lymphedema, e.g. after surgical treatment (e.g. tumor resection, mastectomy +/- axillary dissection, +/- radiotherapy, +/- chemotherapy, scar removal, autologous breast tissue reconstruction). Patients of all clinical lymphedema stages 0 - III. Control patients without lymphedema Written informed consent.

Exclusion criteria

Exclusion criteria: missing written informed consent

Design outcomes

Primary

MeasureTime frame
Detection of postoperative tissue edema using non-contact hyperspectral imaging. Comparison with the following diagnostic procedures - tape measure - two-point discrimination - joint mobility - sonography as reference methods

Secondary

MeasureTime frame
Quality-of-life (patient comfort), time expenditure

Countries

Germany

Contacts

Public ContactMartin Weiss

Department für Frauengesundheit

martin.weiss@med.uni-tuebingen.de07071-29 82211

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026