Safety and Efficacy of Laser Therapy in Gynaecology

NCT04073082 | Unknown

• 1 other identifier: J01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Safety - occurence of adverse effects.

  Recording if any adverse effects occur.

  [1 year]

• Efficacy - number of laser treatments.

  Number of laser treatments needed for lesion clearance.

  [1 year]

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective study assessing the safety and efficacy of laser use in treatment of different gynecology indications.

You may qualify if:

• patients with any of the selected gynecology indications, treated with laser in the period 2013-2018
• signed informed consent

You may not qualify if:

• N/A

Sponsors & Collaborators

• Juna d.o.o.: lead

Study Sites (1)

Juna

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Herpes Genitalis; Condylomata Acuminata; Lichen Sclerosus et Atrophicus; Uterine Cervical Dysplasia; Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Papillomavirus Infections; Warts; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Suppuration; Hidradenitis; Sweat Gland Diseases

Study Officials

• Urška Urska.Bizjak-Ogrinc@juna.si, MD, MSc

  Specialist in obstetrics and gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 29, 2019
• Study Start: July 24, 2019
• Primary Completion: January 24, 2020
• Study Completion: January 24, 2020
• Last Updated: August 30, 2019

Record last verified: 2019-08

Locations

SL (1)