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NCT04073082 Clinical Trial

Safety and Efficacy of Laser Therapy in Gynaecology

Hidradenitis Suppurativa Clinical Trial

Official title:
Safety and Efficacy of Er:YAG and Nd:YAG Laser Therapy in Gynecology: A Retrospective Case Series.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04073082
Other study ID # J01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 24, 2019
Est. completion date January 24, 2020

Study information
Verified date August 2019
Source Juna d.o.o.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 300
Est. completion date January 24, 2020
Est. primary completion date January 24, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Slovenia Juna Ljubljana

Sponsors (1)
Lead Sponsor Collaborator
Juna d.o.o.

Country where clinical trial is conducted

Slovenia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety - occurence of adverse effects. Recording if any adverse effects occur. [1 year]
Primary Efficacy - number of laser treatments. Number of laser treatments needed for lesion clearance. [1 year]
See also
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