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Safety and Efficacy of Laser Therapy in Gynaecology

Sponsor
Juna d.o.o. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04073082
Collaborator
(none)
300
Enrollment
1
Location
6
Anticipated Duration (Months)
49.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Safety and Efficacy of Er:YAG and Nd:YAG Laser Therapy in Gynecology: A Retrospective Case Series.
    Actual Study Start Date :
    Jul 24, 2019
    Anticipated Primary Completion Date :
    Jan 24, 2020
    Anticipated Study Completion Date :
    Jan 24, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Safety - occurence of adverse effects. [[1 year]]

      Recording if any adverse effects occur.

    2. Efficacy - number of laser treatments. [[1 year]]

      Number of laser treatments needed for lesion clearance.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Juna Ljubljana Slovenia 1000

    Sponsors and Collaborators

    • Juna d.o.o.

    Investigators

    • Principal Investigator: Urška Urska.Bizjak-Ogrinc@juna.si, MD, MSc, Specialist in obstetrics and gynecology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Juna d.o.o.
    ClinicalTrials.gov Identifier:
    NCT04073082
    Other Study ID Numbers:
    • J01
    First Posted:
    Aug 29, 2019
    Last Update Posted:
    Aug 30, 2019
    Last Verified:
    Aug 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hidradenitis Suppurativa
    Condylomata Acuminata
    Herpes Genitalis
    Cervical Intraepithelial Neoplasia
    Hidradenitis
    Lichen Sclerosus et Atrophicus

    Study Results

    No Results Posted as of Aug 30, 2019