Early Feasibility Study of the "Easy Light" Fluorecence Imaging System

Summary

This is an early feasibility study to evaluate the device functionality of an open-field handheld wireless fluorecence imaging system for detection of sentinel lymph nodes in women with cervical and uterine cancers who underwent open surgery.

Key Facts

Interventions

Conditions

Eligibility

Inclusion Criteria:

1. Patients with biopsy-proven cervical or uterine cancers;
2. Clinical stage I or II, according to FIGO - The International Federation of Gynecology and Obstetrics;
3. Indication for sentinel lymph node biopsy with or without complementary lymphadenectomy by her medical assistant;
4. Performance status of 0-2;
5. No synchronous malignancies or previous oncological treatments such as radiation or major abdominal surgery;
6. Absence of neuro-psychiatric disorders, apparent or confirmed infections, history of drug allergies, limiting obesity for surgery, and pregnancy or breast feeding;
7. Appropriated cardio-respiratory, hepato-renal and hematological reserves;
8. Signing of the Consent Form.

Exclusion Criteria:

1\. Perioperative impossibility to inject the fluorescent dye indocyanine green in the cervical region due to any locorregional reason.

Outcome Measures

Locations