PAPILOBS GR: A Clinical Investigation to Assess the Effectiveness of PAPILOCARE® in the Regression of Cervix Cytological Abnormalities Caused by HPV.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 524
- 试验地点
- 4
- 主要终点
- The assessment of effectiveness of PAPILOCARE® in the regression of cervix cytological abnormalities caused by HPV.
研究概览
简要总结
The present study is a multicenter, open, non-interventional, prospective observational clinical study for the evaluation of the effectiveness of Papilocare® (medical device with CE mark) in the regression of cervix cytological abnormalities caused by HPV.
详细描述
524 participants were enrolled in the study from approximately 44 Greek sites. At baseline (Visit 1) written informed consent was obtained, participants' eligibility criteria were checked and medical history data were collected. Participants were advised to be treated with Papilocare® for 6 months (1 cannula/day for 21 days during first month + 1 cannula/alternate days for subsequent 5 months). At 6 months (Visit 2) primary and secondary objectives were evaluated. If needed and based on physician's decision, treatment was extended to a total of 12 months (Visit 3) and primary and secondary endpoints were evaluated as well.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over 18 years of age who have been or not vaccinated against HPV.
- •Able to read and understand the Informed Consent Form and agree to participate in the study by signing the Informed Consent Form.
- •Patients with ASCUS or LSIL routine cytological examination and positive High Risk (HR) HPV molecular test, up to 3 months before inclusion in the study.
- •Patients who, due to this condition, undergo a colposcopy and have a concordant result with cytology.
排除标准
- •Any gynecological or non-gynecological condition / lesion / pathology for which, according to clinical judgment, the use of Papilocare® is not recommended or its use has contraindications.
- •Fertile women who do not use effective contraceptive methods, pregnant women, women with suspected pregnancy or intention to become pregnant within the next 6 months, or breastfeeding women.
- •Women who use vaginal contraceptives or other vaginal hormone treatments during the study.
- •Participation in another clinical trial either currently or 4 weeks before enrolling in the study.
- •Any scheduled surgery that precludes compliance with treatment.
- •Known allergies to any of the ingredients of Papilocare®.
结局指标
主要结局
The assessment of effectiveness of PAPILOCARE® in the regression of cervix cytological abnormalities caused by HPV.
时间窗: Assessment at 6 months (or at 12 months)
The percentage of patients with normalized cytology with respective colposcopy findings, as a change from ASCUS or LSIL to normal cytology supported by colposcopy.
次要结局
- The assessment of patient satisfaction level from treatment(Assessment at 6 months (or at 12 months).)
- The assessment of device safety(Treatment period (6 or 12 months).)
- Assessment of ΗPV clearance(Assessment at 6 months (or at 12 months).)