A Study of the New Medical Device Polybactum® (POLARIS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02863536|
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : May 17, 2018
The POLARIS trial is designed as a multicenter, open label, non-comparative, 3 months, clinical study.
Interventional, non-controlled, multicenter trial with a prospective design on one cohort of patients
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Vaginosis||Device: Polybactum®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open Label, Non-comparative, 3 Months Study to Assess the Performance and Safety of the New Medical Device Polybactum® in Reducing the Frequency of Recurrent Bacterial Vaginosis|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||November 2018|
Polybactum® ovules are administered intravaginally on 3 cycles, 1 cycle per month.
Polybactum is a medical device Class IIa used and marketed for the recurrence of Bacterial Vaginosis.
3 cycles treatment one per month.. Duration of one cycle: 1 week; administration for each cycle: 1 ovule at Day 1, 1 ovule at Day 4; 1 ovule at Day 7.In the two following cycles, the same treatment will be repeated immediately after the end of the first and second menstrual bleeding.
- Amsel criteria laboratory diagnostic [ Time Frame: 3 months ]Signs and symptoms of Bacterial Vaginosis assesed also by patients diary (vaginal discharge, burning, erythema, dyspareunia)
- Lactobacilli counting [ Time Frame: 3 months ]The rate of return to normality of vaginal microflora through Lactobacilli counting
- Patient's diary [ Time Frame: 3 months ]Global Assessment of Efficacy by Patient's diary
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863536
|Contact: Barattini Dionisio, MD||+40 774 firstname.lastname@example.org|
|Contact: Serban Rosu, MDemail@example.com|
|Opera Contract Research Organization Srl||Recruiting|
|Timisoara, Timis, Romania, 300209|
|Contact: Ramona Petrita 040721893630 firstname.lastname@example.org|
|Principal Investigator:||Filippo Murina, Prof.dr.||Servizio di Patologia del Tratto Genitale Inferiore U.O. Ostetricia e Ginecologia Ospedale Vittore Buzzi - Universita' degli Studi di Milano Milano (Italy)|