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

University Hospital, Lille

Status: Terminated

Conditions: Pathological Screening Smear; Cervical Cancer

Treatments: Device: Kevorkian curette; Device: Cytobrush

Study type: Interventional

Funder types: Other

Identifiers

NCT04000477

2018-A03087-48 (Other Identifier)

2017_85

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Kevorkian curette

Experimental group

Treatment:

Device: Kevorkian curette

Cytobrush

Experimental group

Treatment:

Device: Cytobrush