- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04073082
Safety and Efficacy of Laser Therapy in Gynaecology
August 28, 2019 updated by: Juna d.o.o.
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.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ljubljana, Slovenia, 1000
- Juna
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Retrospective study assessing the safety and efficacy of laser use in treatment of different gynecology indications.
Description
Inclusion Criteria:
- patients with any of the selected gynecology indications, treated with laser in the period 2013-2018
- signed informed consent
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety - occurence of adverse effects.
Time Frame: [1 year]
|
Recording if any adverse effects occur.
|
[1 year]
|
Efficacy - number of laser treatments.
Time Frame: [1 year]
|
Number of laser treatments needed for lesion clearance.
|
[1 year]
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Urška Urska.Bizjak-Ogrinc@juna.si, MD, MSc, Specialist in obstetrics and gynecology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 24, 2019
Primary Completion (Anticipated)
January 24, 2020
Study Completion (Anticipated)
January 24, 2020
Study Registration Dates
First Submitted
August 27, 2019
First Submitted That Met QC Criteria
August 27, 2019
First Posted (Actual)
August 29, 2019
Study Record Updates
Last Update Posted (Actual)
August 30, 2019
Last Update Submitted That Met QC Criteria
August 28, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Sweat Gland Diseases
- Skin Diseases
- Virus Diseases
- Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- DNA Virus Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Skin Diseases, Infectious
- Skin Diseases, Papulosquamous
- Warts
- Papillomavirus Infections
- Skin Diseases, Viral
- Tumor Virus Infections
- Suppuration
- Skin Diseases, Bacterial
- Herpesviridae Infections
- Carcinoma in Situ
- Lichenoid Eruptions
- Herpes Simplex
- Cervical Intraepithelial Neoplasia
- Hidradenitis Suppurativa
- Hidradenitis
- Condylomata Acuminata
- Lichen Sclerosus et Atrophicus
- Herpes Genitalis
Other Study ID Numbers
- J01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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