Clinical trial · Interventional
Orcellex® Brush Versus Cervex-Brush® on Vault Smear Adequacy in Patients Treated With Radiotherapy for Cervical Cancer
Clinical Trial Comparing the Use of Orcellex® Brush Versus Cervex-Brush® on Vaginal Vault Smear Cytology Adequacy Rate in Patients Treated With Radiotherapy for Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervex Brush | Device | — | UNRESOLVED |
| Orcellex Brush | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Cervex Brush
- interventionNames
- Device: Orcellex Brush
- type
- ACTIVE_COMPARATOR
- label
- Orcellex Brush
- interventionNames
- Device: Cervex Brush
Primary outcomes (1)
- measure
- Vault cytology adequacy rate
- timeFrame
- through study completion, an average of 1 year
- description
- Adequacy of vault smear sample was defined by the Bethesda System as a minimum of 2000 well-visualized and well-preserved squamous cells
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with cervical cancer treated with primary radiotherapy * Patients aged 18 years or older * Patients requiring vaginal vault cytology for follow-up surveillance Exclusion Criteria: * Patients who refuse vaginal examination or vaginal vault smear at follow-up. * Patients who have visible tumour at vaginal vault requiring direct biopsy at speculum examination. * Patients who cannot understand the study purpose and procedure. * Patients who cannot read the words written in Chinese or English.
References
Publications (1)
- DERIVEDSo YL, He MY, Hui SK, Yu EL. Clinical trial comparing the use of Orcellex(R) Brush versus Cervex-Brush(R) on vaginal vault smear cytology adequacy rate in patients treated with radiotherapy for cervical cancer. J Gynecol Oncol. 2025 May;36(3):e43. doi: 10.3802/jgo.2025.36.e43. Epub 2024 Oct 22. PMID 39453394