NCT04000477

Brief Summary

The recommendations on the method and the realization of the cervico-uterine smears are clear. With regard to performing endocervical curettage, several methods are possible without precise consensus. In general, the Kevorkian curette is widely used. However, it is often reported by doctors and patients that curettage is painful. Some articles show that the cytobrush would be less painful. While keeping a percentage of correct curettage failures, it is sought to show that the cytobrush would improve the comfort of the patient during curettage.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

November 5, 2019

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2019

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

20 days

First QC Date

June 26, 2019

Last Update Submit

December 16, 2025

Conditions

Cervical CancerPathological Screening Smear

Keywords

Endocervical curettageKevorkianCytobrushFCV

Outcome Measures

Primary Outcomes (1)

  • Percentage of sampling failures

    Unsatisfactory sampling will be defined by a specimen containing \<20 endocervical cells, \<3 epithelial flaps, and one specimen without stroma.

    once time, Baseline

Secondary Outcomes (1)

  • Pain Assessment Using a Visual Analogue Scale (VAS)

    once time, Baseline

Study Arms (2)

Kevorkian curette

EXPERIMENTAL
Device: Kevorkian curette

Cytobrush

EXPERIMENTAL
Device: Cytobrush

Interventions

CytobrushDEVICE

the brush would be inserted in full until the display of the brush in the endocervical canal disappears. A neck quadrant scan (= quarter turn) will be performed from front to back while simultaneously rotating the brush clockwise, for a total of 3 laps. This would represent 4 sweeps per turn, ie 12 sweeps in total

Cytobrush
Kevorkian curetteDEVICE

the colposcopist holds the curette horizontally and scrapes the endocervical canal all the way around. He realizes 1 small firm and linear movement by quarter turn or 4 movements to realize a complete turn. During this act, the curette must remain inside the canal, and during its extraction, care should be taken not to rotate it so as not to spill the collected tissue contained in the basket of the curette. The tissue material thus obtained must be rapidly immersed in formalin

Kevorkian curette

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients aged 25 to 65 years old whose screening smear returned pathologically and who are therefore followed in colposcopy
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women followed for a cervical pathology requiring endocervical curettage:
  • AGC type (glandular cell atypia) with positive HPV test
  • Frottis ASC-H, LSIL, ASCUS HPV + with non-contributive colposcopy (ZT3)

You may not qualify if:

  • Pregnant woman
  • Women under the age of 25 or over 65
  • Stenosis of the neck complete or tight not allowing the possible insertion of a curette (inadequate size cervical orifice and material)
  • Presence of a vaginal lesion on colposcopic examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de gynécologie endocrinienne et médecine de la reproduction

Lille, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Sophie Jonard, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2019

First Posted

June 27, 2019

Study Start

November 5, 2019

Primary Completion

November 25, 2019

Study Completion

November 25, 2019

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations

FR(1)