Safety and Efficacy of Laser Therapy in Gynaecology | NCT04073082

Studies
Safety and Efficacy of Laser Therapy in Gynaecology

NCT04073082

Sponsor

Juna d.o.o.

Status

Unknown status

Last Update Posted

Aug 30, 2019Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 24, 2019Actual

Primary Completion Date

Jan 24, 2020Estimated

Completion Date

Jan 24, 2020Estimated

First Submitted Date

Aug 27, 2019

First Submission Date that Met QC Criteria

Aug 27, 2019

First Posted Date

Aug 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2019

Last Update Posted Date

Aug 30, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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]

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Urška Urska.Bizjak-Ogrinc@juna.si, MD, MSc	Specialist in obstetrics and gynecology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Juna		Ljubljana		1000	Slovenia

Condition Browse Module

MeSH Terms

ID	Term
D006558	Herpes Genitalis
D003218	Condylomata Acuminata
D018459	Lichen Sclerosus et Atrophicus
D002578	Uterine Cervical Dysplasia
D017497	Hidradenitis Suppurativa

Ancestor Terms

ID	Term
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided