Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cervical cancer is diagnosed in 470,000 women a year worldwide and 273,000 women die of the disease, mostly where there is less helpaccess to healthcare. If detected early, many women can be cured of the disease. However, often women lack access to screening, diagnosis and treatment. Our aim is to compare the performance of a battery-driven colposcope, the Gynocular, to traditional stationary colposcopes in detecting the cervical cancer lesions.

Who can participate?
Women referred to undergo colposcopy to detect cervical lesions can take part in this study.

What does the study involve?
Women are randomly allocated to undergo examination using either the Gynocular or the traditional colposcope. A sample from the cervix is taken from all women for further analysis. The performance of the two instruments are is analysed.

What are the possible benefits and risks of participating?
There are no risks to the women in participating in the study.

Where is the study run from?
1. Department of Obstetrics and Gynecology, Danderyd Hospital, Sweden
2. Department of Clinical Sciences, Karolinska Institute (Karolinska Institutet), Stockholm, Sweden.

When is the study starting and how long is it expected to run for?
The study ran from June 2012 to July 2013.

Who is funding the study?
The H&M Conscious Concious Foundation (Sweden) and Gynius AB (Sweden) funded the study.

Who is the main contact?
Dr Helena Kopp Kallner

Trial website

Contact information



Primary contact

Dr Elisabeth Wikström Shemer


Contact details

Döbelnsgatan 23
111 14

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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



Study hypothesis

A pocket-sized mini-colposcope magnifier (Gynocular) is equally good at detecting cervical lesions compared to a stationary colposcope.

Primary study aim: to demonstrate that the Gynocular magnifier is non-inferior to a stationary colposcope in finding acetowhite cervical lesions during examination in women with precancerous cervical dysplasia.

Secondary study aim: to show that the Gynocular magnifier is non-inferior to a colposcope with regard to sensitivity and specificity in finding cervical intraepithelical neoplasia (CIN) verified in cervical biopsies.

Ethics approval

1. Stockholm Regional Ethical Review Board, 10/04/2010, Dnr: 2013/1855-3 and 2009/2032-31/1
2. The Medical Products Agency of Sweden, 31/10/2013, Dnr: 461:2010/502414.

Study design

Randomized cross-over trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Colposcopy and cervical dysplasia


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 second instrument in order to assess the performance of agreement between the two instruments.

Intervention type



Not Applicable

Drug names

Primary outcome measures

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 outcome measures

Not provided at time of registration

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants


Participant exclusion criteria

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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Döbelnsgatan 23
111 14

Sponsor information


Gynius AB (Sweden)

Sponsor details

Döbelnsgatan 23
111 14

Sponsor type




Funder type


Funder name

H&M Conscious Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Gynius AB (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes