Herpes GenitalisNCT04073082
Safety and Efficacy of Laser Therapy in Gynaecology
An observational study of Herpes Genitalis and Genital Wart, run by Juna d.o.o. at 1 site in Slovenia.
Trial summary
The aim of this study is to retrospectively evaluate the effectiveness and safety of Er:YAG laser for treatment of different gynecological indication, e.g. genital lesions, Bartholin's cyst, condyloma, episiotomy scars, lesions of hydradenitis suppurativa and use of laser in genital surgery used in private practice. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Herpes Genitalis, Genital Wart, Lichen Sclerosus
- How many people
- 300 participants
- Where
- 1 siteSlovenia
- Study dates
- 24 Jul 2019to 24 Jan 2020
- Phase
- Observational
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Retrospective study assessing the safety and efficacy of laser use in treatment of different gynecology indications.
Who may be able to join
- patients with any of the selected gynecology indications, treated with laser in the period 2013-2018
- signed informed consent
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Er:YAG and Nd:YAG Laser Therapy in Gynecology: A Retrospective Case Series.
The aim of this study is to retrospectively evaluate the effectiveness and safety of Er:YAG laser for treatment of different gynecological indication, e.g. genital lesions, Bartholin's cyst, condyloma, episiotomy scars, lesions of hydradenitis suppurativa and use of laser in genital surgery used in private practice.
- Conditions
- Herpes Genitalis, Genital Wart, Lichen Sclerosus, Cervical Intraepithelial Neoplasia, Labial Reduction Surgery, Episiotomy Scar
- Medical subject headings
- Herpes Genitalis, Condylomata Acuminata, Lichen Sclerosus et Atrophicus, Uterine Cervical Dysplasia, Hidradenitis Suppurativa
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - occurence of adverse effects.
Recording if any adverse effects occur.
Measured: [1 year]
Efficacy - number of laser treatments.
Number of laser treatments needed for lesion clearance.
Measured: [1 year]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start24 Jul 2019
- Primary completion24 Jan 2020 (estimated)
- Study completion24 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes GenitalisStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juna d.o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Urška Urska.Bizjak-Ogrinc@juna.si, MD, MSc, Principal investigator, Specialist in obstetrics and gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073082
- Sponsor's protocol ID
- J01
- Status last verified
- Aug 2019
- First submitted
- 27 Aug 2019
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No