Cervical LesionNCT05668806
RWE Study in the Treatment of Cervical Lesions of Various Etiology
An observational study of Cervical Lesion and Vaginal Bleeding, run by Perfect Care Distribution at 15 sites in Romania.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Lesion, Vaginal Bleeding
- What is being tested?
- Cerviron
- Type of treatment
- Medical device
- How many people
- 345 participants
- Where
- 15 sitesRomania
- Study dates
- 20 May 2021to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Women aged above 18 years with a clearly diagnosed non-infectious gynecological disease and patients with traumatic or surgical lesions.
Who may be able to join
- Patients with a clearly diagnosed non-infectious gynecological disease and patients with traumatic or surgical lesions.
- Patients with either of the following medical history: trauma of the cervix, pain, bleeding after sexual intercourse, postpartum injuries or postoperative cervical lesions.
Who cannot join
- Patients with cervical cancer.
- Patients with vulvar cancer
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Romania15 sites
Spitalul Clinic Dr. Ion Cantacuzino Bucharest
Bucharest
Med Life Humanitas Cluj-Napoca
Cluj-Napoca
Cabinet Medical - Dr. Saleh K. Majed
Craiova
Cabinet Medical - Dr. Surpanelu Oana
Iași
MediBlue
Iași
Clinica Natisan Pitesti
Piteşti
Cabinet Dr. Rădulescu G. Mihaela Elena
Râmnicu Vâlcea
Ramnicu Valcea
Râmnicu Vâlcea
Cabinet Ginecologic Dr. Popescu Sibiu
Sibiu
Clinica iMED
Sibiu
Pan Medical Sibiu
Sibiu
Bradmed SRL
Târgu Jiu
Cabinet Dr. Ioana Trotea Targu Jiu
Târgu Jiu
Clinica Medicala Dr. Cioata Ionel Trifon
Timișoara
Spitalul Judetean de Urgenta Tulcea
Tulcea
About this study
Official title: Study of Real-world Evidence in Patients Treated With Cerviron Vaginal Ovules in the Treatment of Cervical Lesions of Various Etiology
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.
Read the detailed description
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.
- Conditions
- Cervical Lesion, Vaginal Bleeding
- Being tested
- Cerviron
- Keywords
- cervical ectropion, vaginal discharge, cervix lesion
- Medical subject headings
- Uterine Hemorrhage, Vaginal Discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CervironDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (2)
Clinical Performance assessed by the investigator
An assessment of the cervical lesions by gynecological examination (visual evaluation)
Measured: 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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start20 May 2021
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perfect Care Distribution
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MDX Research
- Responsible party
- Sponsor
- Investigators
- Ema Peta, Study director, Perfect Care Distribution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668806
- Sponsor's protocol ID
- CYRONRW/02/2022
- Status last verified
- Dec 2022
- First submitted
- 18 Nov 2022
- Last updated
- 30 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Petre I, Sirbu DT, Petrita R, Toma AD, Peta E, Dimcevici-Poesina F. Real-world study of Cerviron(R) vaginal ovules in the treatment of cervical lesions of various etiologies. Biomed Rep. 2023 Jul 7;19(2):54. doi: 10.3892/br.2023.1618. eCollection 2023 Aug.
PubMed 37546352
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Real-world Evidence in Patients Treated With Cerviron Vaginal Ovules in the Treatment of Cervical Lesions of Various Etiology
- ClinicalTrials.gov ID
- NCT05668806
- Acronym / sponsor ID
- CYRONRW/02/2022
- Conditions
- Cervical Lesion, Vaginal Bleeding
- Keywords
- cervical ectropion, vaginal discharge, cervix lesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Perfect Care DistributionIndustry (pharma, biotech, devices)
- Collaborators
- MDX Research
- Study start
- 20 May 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 30 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women aged above 18 years with a clearly diagnosed non-infectious gynecological disease and patients with traumatic or surgical lesions.
Key inclusion criteria (2 listed)
- Patients with a clearly diagnosed non-infectious gynecological disease and patients with traumatic or surgical lesions.
- Patients with either of the following medical history: trauma of the cervix, pain, bleeding after sexual intercourse, postpartum injuries or postoperative cervical lesions.
Key exclusion criteria (2 listed)
- Patients with cervical cancer.
- Patients with vulvar cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CervironCerviron® 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. | Device | – |
Primary outcome
Rate of treatment-related adverse events in subjects participating in the clinical investigation
Time frame: 3 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
2 secondary outcomes
Clinical Performance assessed by the investigator
Time frame: 3 months
Patient Satisfaction
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
- Derived from this study: PubMed 37546352Petre I, Sirbu DT, Petrita R, Toma AD, Peta E, Dimcevici-Poesina F. Real-world study of Cerviron(R) vaginal ovules in the treatment of cervical lesions of various etiologies. Biomed Rep. 2023 Jul 7;19(2):54. doi: 10.3892/br.2023.1618. eCollection 2023 Aug.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ema Peta study director
Perfect Care Distribution
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Lesion and Vaginal Bleeding, run by Perfect Care Distribution at 15 sites in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of treatment-related adverse events in subjects participating in the clinical investigation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05668806, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2022.