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Orcellex® Brush Versus Cervex-Brush® on Vault Smear Adequacy in Patients Treated With Radiotherapy for Cervical Cancer

NCT04461574 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-03-17

No results posted yet for this study

Summary

Vaginal vault cytology is commonly used for follow-up surveillance in patients treated for cervical cancer. It is known that the smear inadequacy rate is high, especially in patients post-radiotherapy at 10%. The current practice is to use Cervex-Brush®, which was designed for cervical smear taking. Cervix will shrink into a dimple with a flat vaginal vault and vagina may be stenotic after radiotherapy, rendering the use of the conventional sampling device difficult. Orcellex® Brush was designed to collect cells from oral mucosa, with high patient satisfaction and low smear inadequacy of 1% in one study. As both the vaginal vault mucosa and oral mucosa are flat surface lined with stratified squamous epithelium, the use of Orcellex® Brush in vaginal vault smear appeared applicable. It has a smaller head with a flat surface of hair, which might better fit the flat vault surface and narrow vaginal canal. It is postulated that the Orcellex® Brush helps in improving vaginal vault smear adequacy rate in patients after radiotherapy treatment for cervical cancer.

Conditions

Interventions

DEVICE

Orcellex Brush

Subjects will receive vaginal vault smear using both Orcellex Brush and Cervex Brush at the same follow-up visit, with order of smear taking decided by randomization.

DEVICE

Cervex Brush

Subjects will receive vaginal vault smear using both Orcellex Brush and Cervex Brush at the same follow-up visit, with order of smear taking decided by randomization.

Sponsors & Collaborators

  • Princess Margaret Hospital, Hong Kong

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04461574 on ClinicalTrials.gov