A Viveve Experience Normalizes Untreated Selective Seroto... | NCT03679702

Studies
A Viveve Experience Normalizes Untreated Selective Serotonin Reuptake Inhibitor (SSRI) Sexuality Syndrome

NCT03679702

Sponsor

Michael Krychman, MD

Status

Unknown status

Last Update Posted

Nov 21, 2018Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Sexual Dysfunction

Interventions

Viveve System

Countries

United States

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

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2018Estimated

Primary Completion Date

Dec 1, 2019Estimated

Completion Date

Dec 1, 2019Estimated

First Submitted Date

Sep 19, 2018

First Submission Date that Met QC Criteria

Sep 19, 2018

First Posted Date

Sep 20, 2018Actual

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

Nov 19, 2018

Last Update Posted Date

Nov 21, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael Krychman, MD, Michael Krychman, MD, Southern California Center for Sexual Health and Survivorship MedicineSponsor-Investigator

Lead Sponsor

Michael Krychman, MDOTHER

Collaborators

Name	Class
Viveve Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A pilot study to investigate non-surgical treatment for women who suffer from sexual complaints secondary to SSRI Sexuality Syndrome.

Detailed Description

Not provided

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

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active treatment	Other		Device: Viveve System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Viveve System	Device	Radiofrequency device utilized in general surgical procedures for electrocoagulation and hemostasis.	Active treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety - Adverse Events	safety of treatment of female sexual dysfunction secondary to SSRI sexuality syndrome	baseline to 6 month

Secondary Outcomes

Measure	Description	Time Frame
Female Sexual Function Index (FSFI)	Female Sexual Function Index total score (Minimum: 2.0) (Maximum: 36), Higher scores are better outcome.	baseline to 3 and 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Currently using SSRI for 3 months at a stable dose

Exclusion Criteria:

Pregnant, currently breastfeeding, or breast-fed within the last 6 months
Has any implantable electrical device that could potentially be affected by use of radiofrequency.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Krychman	Contact	949-764-9300		mkrychman@icloud.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southern California Center for Sexual Health and Survivorship Medicine		Newport Beach	California	92663	United States

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

Condition Browse Module

MeSH Terms

ID	Term
D012735	Sexual Dysfunction, Physiological

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided