Effect of Laser in Treatment of Vulval Warts | NCT03830047

Studies
Effect of Laser in Treatment of Vulval Warts

NCT03830047

Sponsor

Aljazeera Hospital

Status

Unknown status

Last Update Posted

Aug 6, 2019Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Vulval Wart

Interventions

nd yag laser

Countries

Egypt

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

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 7, 2019Actual

Primary Completion Date

Oct 15, 2019Estimated

Completion Date

Nov 20, 2019Estimated

First Submitted Date

Feb 2, 2019

First Submission Date that Met QC Criteria

Feb 2, 2019

First Posted Date

Feb 5, 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 4, 2019

Last Update Posted Date

Aug 6, 2019Actual

Name	Class
National Research Centre, Egypt	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Vulval warts is a magor problem that affects women .

Detailed Description

The causative organism for vulval warts is human papilloma virus There are many treatment modalities that can trat these warts

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
nd yag laser	Active Comparator	Applying nd yag laser to vulva	Device: nd yag laser
Co2 laser	Sham Comparator	Applying CO2 laser to vulva	Device: nd yag laser

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nd yag laser	Device	nd yag laser will be applied on the vulval warts	Co2 laser nd yag laser

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of women who will be completely cured by laser beam	how laser will cure the warts	within 2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women who have vulval warts
Age between 18- 40 years

Exclusion Criteria:

warts that were previously treated by surgery or cryotherapy

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Females who have vulval warts

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud Alalfy, PhD	Contact	01002611058		mahmoudalalfy@ymail.com

Overall Officials

Name	Affiliation	Role
Mahmoud Alalfy, PhD	Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Algazeerah and Kasralainy hospital	Not yet recruiting	Giza			Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D053844	Lasers, Solid-State
D007834	Lasers

Ancestor Terms

ID	Term
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided