MedDataX Logo

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

NCT ID: NCT04000477

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-05

Study Completion Date

2019-11-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Cancer Pathological Screening Smear

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Endocervical curettage Kevorkian Cytobrush FCV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Kevorkian curette

Group Type EXPERIMENTAL

Kevorkian curette

Intervention Type DEVICE

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

Cytobrush

Group Type EXPERIMENTAL

Cytobrush

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cytobrush

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

Intervention Type DEVICE

Kevorkian 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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sophie Jonard, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service de gynécologie endocrinienne et médecine de la reproduction

Lille, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-A03087-48

Identifier Type: OTHER

Identifier Source: secondary_id

2017_85

Identifier Type: -

Identifier Source: org_study_id