Condition category
Urological and Genital Diseases
Date applied
08/12/2013
Date assigned
30/01/2014
Last edited
30/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
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

Type

Scientific

Primary contact

Dr Elisabeth Wikström Shemer

ORCID ID

Contact details

Döbelnsgatan 23
Sweden
111 14
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

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

Acronym

ARTEMIS

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

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

Condition

Colposcopy and cervical dysplasia

Intervention

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

Other

Phase

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

01/06/2012

Overall trial end date

01/07/2013

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Female

Target number of participants

125

Participant exclusion criteria

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

Recruitment start date

01/06/2012

Recruitment end date

01/07/2013

Locations

Countries of recruitment

Sweden

Trial participating centre

Döbelnsgatan 23
Sweden
111 14
Sweden

Sponsor information

Organisation

Gynius AB (Sweden)

Sponsor details

Döbelnsgatan 23
Stockholm
111 14
Sweden

Sponsor type

Industry

Website

http://gynocular.com

Funders

Funder type

Industry

Funder name

H&M Conscious Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Gynius AB (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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