The use of a mini-colposcope, the Gynocular, to detect cervical lesions in women with abnormal cytology and high-risk human papillomavirus: a randomized, cross-over, non-inferiority trial

A comparison of the performance of the Gynocolar and stationary colposcope by the Swede score colposcopy system in women with abnormal cytology: a randomized cross-over trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN72259107

Enrollment

125

Registered

2014-01-30

Start date

2012-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colposcopy and cervical dysplasia Urological and Genital Diseases Dysplasia of cervix uteri

Interventions

Women will be randomly allocated in blocks of clinic day to start the examination with either the stationary colposcope or the Gynocular. Then, the woman will be examined by the same examiner with the

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women with atypical cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL) and high-risk human papillomavirus (HPV) and HR HPV positivity, or any high grade lesion (CIN II or more) regardless of HPV status, referred for colposcopy to the Department of Obstetrics and Gynecology, Danderyd Hospital, Stockholm, Sweden between June 2012 and June 2013 2. Ability to understand written and oral information in Swedish 3. Willingness to sign informed consent to take part in the study after oral and written information

Exclusion criteria

Exclusion criteria: 1. Ongoing vaginal bleeding 2. Any previous gynecological examinations within a week prior to the examination 3. Pregnancy

Design outcomes

Primary

Measure	Time frame
Each patient will be assessed by the Swede score systematic colposcopy system, where each of five colposcopic variables (acetowhiteness, margins plus surface, vessel pattern, lesion size and iodine staining) are given a score of 0, 1 or 2 points. All women will also have a liquid-based cytology specimen taken at the time of examination using a plastic spatula on the cervix and a cervix brush in the cervical canal. The examination will be finalized with one or more biopsies taken from areas of suspected cervical lesions when the Swede score is above 0.	—

Measure

Time frame

Each patient will be assessed by the Swede score systematic colposcopy system, where each of five colposcopic variables (acetowhiteness, margins plus surface, vessel pattern, lesion size and iodine staining) are given a score of 0, 1 or 2 points. All women will also have a liquid-based cytology specimen taken at the time of examination using a plastic spatula on the cervix and a cervix brush in the cervical canal. The examination will be finalized with one or more biopsies taken from areas of suspected cervical lesions when the Swede score is above 0.

—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026