An observational study in Cervical Lesion and Vaginal Bleeding, sponsored by Perfect Care Distribution. Completed at 15 sites in Romania. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-30.
Sponsored by Perfect Care Distribution · Observational
The aim of the study was to assess the post-market performance and tolerability of Cerviron® ovules in the treatment and management of cervical lesions of different etiologies. The study included clinical data related to aspect of lesions performed during routine colposcopy exams, the degree of re-epithelialization of the cervical mucosa, vaginal pH, pain level, and vaginal bleeding level.
This study is an observational, post-marketing study conducted between May-July 2021.
The aim of the study was to assess the post-market performance and tolerability of Cerviron® ovules in the treatment and management of cervical lesions of different etiologies.
The secondary objective of this clinical investigation is the assessment of performance of the medical device by clinical exam and patients' degree of satisfaction related to the use of the medical device.
The study population included 345 participants aged 20-70 years with either a cervical lesion under treatment or with recent surgical removal of a cervical lesion.
90 studies on the registry are indexed under Uterine Hemorrhage; 13 are open to participants now.
This study's enrollment of 345 is above the median of 122 across 27 observational studies indexed under Uterine Hemorrhage.
Browse Uterine Hemorrhage studies →Perfect Care Distribution is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women aged above 18 years with a clearly diagnosed non-infectious gynecological disease and patients with traumatic or surgical lesions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Cerviron® is an invasive medical device of short-term use classified under annex VIII of the European Regulation 2017/745 as class IIb according to Rule 21 (devices composed of substances or of combinations of substances to be introduced into the human body via a body orifice or applied to the skin and absorbed by or locally dispersed in the human body). Cerviron® has a complex composition consisting of three topical pharmaceutical products - hexylresorcinol, collagen and bismuth subgallate - and four phytotherapeutic extracts - Calendula officinalis, Hydrastis canadensis, Thymus vulgaris extract and Curcuma longa. The Instructions for use specify its field of use as adjuvant in the treatment of acute and chronic vulvovaginitis of mechanical etiology, caused by changes of vaginal pH and changes of the vaginal flora and of cervical lesions of mechanical origin.
Rate of treatment-related adverse events in subjects participating in the clinical investigation
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 3 months
Clinical Performance assessed by the investigator
An assessment of the cervical lesions by gynecological examination (visual evaluation)
Time frame: 3 months
Patient Satisfaction
An assessment on a 5-point Likert scale to evaluate the degree of satisfaction after the treatment. The scale rates satisfaction from Very satisfied (maximum) to Very unsatisfied (minimum).
Time frame: 3 months
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Perfect Care Distribution