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

November 19, 2020 updated by: University Hospital, Lille

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

588

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kevorkian curette
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
Experimental: Cytobrush
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
once time, Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain Assessment Using a Visual Analogue Scale (VAS)
Time Frame: once time, Baseline
once time, Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Sophie Jonard, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

June 26, 2019

First Posted (Actual)

June 27, 2019

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017_85
  • 2018-A03087-48 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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