Comparison Between Diode Laser and Bleomycin in Treatment... | NCT06510829

Studies
Comparison Between Diode Laser and Bleomycin in Treatment of Hemangioma

NCT06510829

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Jul 19, 2024Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Bleomycin Adverse Reaction

Interventions

Diode laser

Countries

Not provided

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

Jul 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2024Estimated

Primary Completion Date

Sep 2026Estimated

Completion Date

Oct 2026Estimated

First Submitted Date

Jul 15, 2024

First Submission Date that Met QC Criteria

Jul 15, 2024

First Posted Date

Jul 19, 2024Actual

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

Jul 15, 2024

Last Update Posted Date

Jul 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Assessment of the Effectiveness of Bleomycin Intralesional Injection and Diode Laser on Management of Infantile Hemangioma., with regard to :

Clinically based on Change in the Size and Color of Hemangioma.
Ultrasonography considering Vascularity ,Echogenicity , Height , and Morphology .
Comparison of Complications associated with Bleomycin and Diode Laser.

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		Group will be treated with intralesional bleomycin injection
Group b		Group will be treated with application of diode laser	Device: Diode laser

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diode laser	Device	Application of laser waves on the lesion	Group b

Measure	Description	Time Frame
Effect of diode laser on hemangioma		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 3 Months and 1 Year old.
Non Complicated Infantile Hemangioma

Exclusion Criteria:

Younger than 3 Months or older than 1 Year.
Complicated Infantile Hemangioma

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

12 Months

Standard Ages

Child

Study Population

Comparative Study Between Effect of Bleomycin Intralesional Injection And Application of Diode Laser on Infantile Hemangioma .

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054023	Lasers, Semiconductor

Ancestor Terms

ID	Term
D007834	Lasers
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies

Browse Leaves

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Browse Branches

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