The Effect of Additional Laser Treatments. | NCT04111952

Studies
The Effect of Additional Laser Treatments.

NCT04111952

Sponsor

Rambam Health Care Campus

Status

Unknown status

Last Update Posted

Apr 20, 2022Actual

Enrollment

253Actual

Phase

Not Applicable

Conditions

Lax Vaginal Introitus

Interventions

CO2 laser
Sham laser

Countries

Israel

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

Apr 2022

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

Jun 1, 2019Actual

Primary Completion Date

Nov 1, 2021Actual

Completion Date

Jan 28, 2023Estimated

First Submitted Date

Sep 30, 2019

First Submission Date that Met QC Criteria

Sep 30, 2019

First Posted Date

Oct 2, 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

Apr 19, 2022

Last Update Posted Date

Apr 20, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

ROY LAUTERBACH MD, Principal Investigator, Rambam Health Care CampusPrincipal Investigator

Lead Sponsor

Rambam Health Care CampusOTHER

Collaborators

Not provided

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

Women previously treated with vaginal CO2 laser will receive an additional treatment 6 months after cessation of previous laser treatment or a sham laser treatment. The efficacy and safety of the additional treatment will be assessed.

Detailed Description

The following study is intended to evaluate the efficacy and safety of an additional laser treatment for women previously treated for gynecological indications with laser treatments. Women will be randomized to one of 2 groups: 1. Study group-additional single laser treatment. 2. Control group-single sham laser treatment. All women will fill out validated questionnaires regarding sexual function, urinary stress incontinence and satisfaction after treatment. All women will be followed for an additional 6 months to evaluate the length of effect.

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

253Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Additional laser treatment	Experimental	Women receiving a single laser treatment.	Device: CO2 laser
Sham laser treatment	Sham Comparator	Women receiving sham laser treatment.	Device: Sham laser

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CO2 laser	Device	A single session of CO2 vaginal laser treatment	Additional laser treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of effect	The duration of symptom improvement.	From the treatment session up to 6 months post-treatment

Secondary Outcomes

Measure	Description	Time Frame
Female sexual function index	Changes in the female sexual function index questionnaire score (range 0-35)	From the treatment session up to 6 months post-treatment
Sexual intercourse	Improvement in the monthly rate of sexual intercourse

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Previously treated with 3 laser treatments.
Clear PAP test from the last 3 years.

Exclusion Criteria:

Vaginal bleeding of unknown source.
Vaginal surgery in the past 9 months.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roy Lauterbach, MD	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam health care campus		Haifa			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054020	Lasers, Gas

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided