An open, prospective, comparative clinical trial to evaluate the improvement of the colposcopist with the use of DySIS* compared to conventional colposcopy.

• Conditions: 10038594; pre-maligne cervix afwijkingen; Cervical intraepithelial neoplasia / Forerunner lesions of cervical cancer

• Registration Number: NL-OMON31605
• Lead Sponsor: Forth Photonics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

- Female
- At least 18 years of age
- Intact cervix (no history of LEEP or surgical treatment involving damage to the transformation zone of the cervix).
- To be able to undergo a colposcopy.
- Study group only: An abnormal cytological test result and/or positive hrHPV test.
- Controle group: No abnormal cytology or positive hrHPV test.

Exclusion Criteria

- History of surgery on the cervix
- Previous pelvic radiotherapy.
- Pregnancy or pregnant in the last 3 months.
- Breast-feeding, or breast-feeding in the last 3 months.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Consensus in DySIS colposcopic and conventional colposcopic impression of a<br /><br>lesion and histology (*golden standard*).</p><br>