Safety and Efficacy of Laser Therapy in Gynaecology

• Conditions: Herpes Genitalis; Bartholin Cyst; Lichen Sclerosus; Episiotomy Scar; Genital Wart; Cervical Intraepithelial Neoplasia; Hidradenitis Suppurativa; Labial Reduction Surgery

• Registration Number: NCT04073082
• Lead Sponsor: Juna d.o.o.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-24
• Status Verified: 2019-08
• Study First Submitted: 2019-08-27
• Study First Submitted QC: 2019-08-27
• Last Update Submitted: 2019-08-28
• Study First Posted: 2019-08-29
• Last Update Posted: 2019-08-30
• Primary Completion: 2020-01-24
• Study Completion: 2020-01-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety - occurence of adverse effects.	[1 year]	Recording if any adverse effects occur.
Efficacy - number of laser treatments.	[1 year]	Number of laser treatments needed for lesion clearance.

Trial Locations

Locations (1)

Juna; 🇸🇮 Ljubljana, Slovenia