CO2-laser Treatment for Caesarean Section Scars | NCT02651298

Studies
CO2-laser Treatment for Caesarean Section Scars

NCT02651298

Sponsor

Bispebjerg Hospital

Status

Completed

Last Update Posted

Jan 8, 2016Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Cicatrix

Interventions

Fractional Co2-laser

Countries

Denmark

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

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Jan 2, 2016

First Submission Date that Met QC Criteria

Jan 7, 2016

First Posted Date

Jan 8, 2016Estimated

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

Jan 7, 2016

Last Update Posted Date

Jan 8, 2016Estimated

Name	Class
Lumenis Be Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Fractional Co2-laser for treatment of mature caesarean section scars.

Detailed Description

Randomized split scar study to document improvement of caesarean section scars as compared to untreated control scar.

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

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fractional CO2-laser	Experimental	3 treatments with fractional co2-laser	Device: Fractional Co2-laser
Untreated control	No Intervention	untreated control side of caesarean section scar

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fractional Co2-laser	Device	laser treatment	Fractional CO2-laser	Ablative fractional laser

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
patient observer scar scale	validated scar scale evaluations	up until 6 months post treatment

Secondary Outcomes

Measure	Description	Time Frame
erythema measured by reflectance	measured by reflectance	1 months post treatment
pigmentation measured by reflectance	measured by reflectance

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

mature caesarean section scar

Exclusion Criteria:

systemic uncontrolled disease
recent or current cancer
smoking
keloid formation
wounds or local disease int treatment area
pregnancy or lactation

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Merete Haedersdal, Professor	Bispebjerg Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bispebjerg Hospital		Copenhagen			Denmark

Condition Browse Module

MeSH Terms

ID	Term
D002921	Cicatrix

Ancestor Terms

ID	Term
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided