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Comparison of 2 Types of Cervical Specimens in Patients With a Pathological Screening Smear

Endocervical Curettage Performed With a Kevorkian Curette Versus Cytobrush in Patients With ASC-H, LSIL, ASCUS HPV Positive and Non-contributory Colposcopy (ZT3) Smear or Atypical Pap Smear With Positive HPV Test

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04000477
Acronym
ENDOCOL
Enrollment
3
Registered
2019-06-27
Start date
2019-11-05
Completion date
2019-11-25
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Pathological Screening Smear

Keywords

Endocervical curettage, Kevorkian, Cytobrush, FCV

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.

Interventions

DEVICECytobrush

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

DEVICEKevorkian curette

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

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of sampling failuresonce time, BaselineUnsatisfactory sampling will be defined by a specimen containing \<20 endocervical cells, \<3 epithelial flaps, and one specimen without stroma.

Secondary

MeasureTime frame
Pain Assessment Using a Visual Analogue Scale (VAS)once time, Baseline

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026