Clinical trial · Interventional
Early Feasibility Study of the "Easy Light" Fluorecence Imaging System
Early Feasibility Study of an Open-Field Handheld Wireless Fluorecence Imaging System for Detection of Sentinel Lymph Nodes in Women With Cervical and Uterine Cancers
NCT05004623CI-TRIAL-00053265completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
| Uterine Neoplasms | Uterine Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel Lymph Node Biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Sentinel Lymph Node Biopsy
- description
- Sentinel lymph node biopsy by indocyanine green (ICG) fluorescent dye technique, using a prototype of the Easy Light device. Lymph node dissection in each hemipelvis should be performed as standard if no sentinel lymph node is detected. Decision of proceeding with complementary lymph node dissection after sentinel lymph node detection is a surgeon decision, according to his/her usual practice.
- interventionNames
- Device: Sentinel Lymph Node Biopsy
Primary outcomes (1)
- measure
- The ability to detect sentinel lymph nodes.
- timeFrame
- Intraoperativelly
- description
- The ability to detect at least one sentinel lymph node per patient during open surgeries.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.