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Safety and Efficacy of Laser Therapy in Gynaecology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04073082
Recruitment Status : Active, not recruiting
First Posted : August 29, 2019
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
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.

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

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Study Type : Observational
Estimated 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 : July 24, 2019
Estimated Primary Completion Date : January 24, 2020
Estimated Study Completion Date : January 24, 2020





Primary Outcome Measures :
  1. Safety - occurence of adverse effects. [ Time Frame: [1 year] ]
    Recording if any adverse effects occur.

  2. Efficacy - number of laser treatments. [ Time Frame: [1 year] ]
    Number of laser treatments needed for lesion clearance.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Retrospective study assessing the safety and efficacy of laser use in treatment of different gynecology indications.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04073082


Locations
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Slovenia
Juna
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Juna d.o.o.
Investigators
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Principal Investigator: Urška Urska.Bizjak-Ogrinc@juna.si, MD, MSc Specialist in obstetrics and gynecology

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Responsible Party: Juna d.o.o.
ClinicalTrials.gov Identifier: NCT04073082     History of Changes
Other Study ID Numbers: J01
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Condylomata Acuminata
Herpes Genitalis
Cervical Intraepithelial Neoplasia
Lichen Sclerosus et Atrophicus
Neoplasms
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Herpes Simplex
Herpesviridae Infections