NCT02221076

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 12, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2016

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

1.8 years

First QC Date

August 12, 2014

Last Update Submit

August 28, 2017

Conditions

Cervix CancerEndometrium CancerOvarian CancerCarcinoma in Situ of Fallopian Tube

Keywords

CellvizioEndomicroscopyRobot-assisted procedureCervix cancerEndocervix cancerEndometrium cancerOvarian cancerTubal cancerColposcopyHysteroscopy

Outcome Measures

Primary Outcomes (1)

  • The number of participants with adverse events, their type and severity.

    8 months

Secondary Outcomes (1)

  • Number of interpretable images per organ and per pathology

    8 months

Study Arms (1)

Confocal Laser Endomicroscopy (CLE)

EXPERIMENTAL

The patient will undergo a 10 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs.

Device: Confocal Laser Endomicroscopy (CLE)

Interventions

Confocal Laser Endomicroscopy (CLE)DEVICE

Real-time microscopic imaging of living tissue during the standard procedure

Also known as: Optical biopsy, Cellvizio
Confocal Laser Endomicroscopy (CLE)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for a colposcopy
  • Patients scheduled for a hysteroscopy
  • Patients scheduled for a surgical treatment for a suspected cervix/ endocervix/ endometrium lesion
  • years or older.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli Calmettes

Marseille, 13273, France

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEndometrial NeoplasmsOvarian Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • ERIC LAMBAUDIE

    IPC, Marseille, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2014

First Posted

August 20, 2014

Study Start

July 1, 2014

Primary Completion

April 18, 2016

Study Completion

April 18, 2016

Last Updated

August 29, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)