Cervical CancerENDOCOLNCT04000477
Comparison of 2 Types of Cervical Specimens in Patients With a Pathological Screening Smear
A study testing Cytobrush and Kevorkian curette in people with Cervical Cancer and Pathological Screening Smear, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Cervical Cancer, Pathological Screening Smear
- What is being tested?
- Cytobrush and Kevorkian curette
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2019to 25 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service de gynécologie endocrinienne et médecine de la reproduction
Lille
About this study
Official title: 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
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.
- Conditions
- Cervical Cancer, Pathological Screening Smear
- Being tested
- Cytobrush, Kevorkian curette
- Keywords
- Endocervical curettage, Kevorkian, Cytobrush, FCV
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| Kevorkian curette | Experimental | Not described Receives: Device: Kevorkian curette |
| Cytobrush | Experimental | Not described Receives: Device: Cytobrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of sampling failures
Unsatisfactory sampling will be defined by a specimen containing <20 endocervical cells, <3 epithelial flaps, and one specimen without stroma.
Measured: once time, Baseline
Secondary outcomes (1)
Pain Assessment Using a Visual Analogue Scale (VAS)
Measured: once time, Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start5 Nov 2019
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Why it stopped: default inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Jonard, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000477
- Sponsor's protocol ID
- 2017_85
- Other IDs
- 2018-A03087-48
- Acronym
- ENDOCOL
- Status last verified
- Dec 2025
- First submitted
- 26 Jun 2019
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04000477
- Acronym / sponsor ID
- ENDOCOL / 2017_85
- Conditions
- Cervical Cancer, Pathological Screening Smear
- Keywords
- Endocervical curettage, Kevorkian, Cytobrush, FCV
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: default inclusion
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kevorkian curette | Experimental | Device: Kevorkian curette |
| Cytobrush | Experimental | Device: Cytobrush |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytobrushthe 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 | Device | Cytobrush |
| Kevorkian curettethe 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 | Device | Kevorkian curette |
Primary outcome
Percentage of sampling failures
Time frame: once time, Baseline
Unsatisfactory sampling will be defined by a specimen containing <20 endocervical cells, <3 epithelial flaps, and one specimen without stroma.
1 secondary outcome
Pain Assessment Using a Visual Analogue Scale (VAS)
Time frame: once time, Baseline
Results and safety
The study was stopped early (reason given: default inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Jonard, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytobrush and Kevorkian curette in people with Cervical Cancer and Pathological Screening Smear, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: default inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of sampling failures (time frame: once time, Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.