Clinical trial · Interventional
Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Procedures.
Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Examinations or Surgical Procedures for Gynecological Cancers : a Feasibility Study
- 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)
The protocol aims at demonstrating the technical feasibility and safety of doing endomicroscopic imaging (both probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy, nCLE) during colposcopy, hysteroscopy, and surgical procedures (open surgery and laparoscopic robot assisted or not) to examine all pelvic tissues including cervix, uterus, adnexia, peritoneum, normal and pathologic aspect.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma in Situ of Fallopian Tube | — | UNRESOLVED | — |
| Cervix Cancer | — | UNRESOLVED | — |
| Endometrium Cancer | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Confocal Laser Endomicroscopy (CLE) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Confocal Laser Endomicroscopy (CLE)
- description
- The patient will undergo a 10 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs.
- interventionNames
- Device: Confocal Laser Endomicroscopy (CLE)
Primary outcomes (1)
- measure
- The number of participants with adverse events, their type and severity.
- timeFrame
- 8 months
Secondary outcomes (1)
- measure
- Number of interpretable images per organ and per pathology
- timeFrame
- 8 months
- description
- Each sequence acquired during the cases will be annotated as to which organ it is, and the final diagnosis of the specimen (healthy, cancerous, inflammation, etc...). Thanks to this, a more complete atlas of images obtained gynaecological organs and conditions will be developed. This atlas will be used to describe image interpretation criteria for endomicroscopic images of various organs and conditions. This work will be done in conjunction by the investigators the histopathologist, and an Mauna Kea Technologies representative familiar with image interpretation in current endomicroscopy indications.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients scheduled for a colposcopy * Patients scheduled for a hysteroscopy * Patients scheduled for a surgical treatment for a suspected cervix/ endocervix/ endometrium lesion * 18 years or older. Exclusion Criteria: * Allergy to fluorescein * Previous life-threatening allergic reactions and known hypersensitivity * Pregnancy or breast-feeding * History of cardio-pulmonary disease (including bronchial asthma) * Restricted renal function * Patients under a beta-blockers treatment
References
Publications (0)
Data not yet available