Pelvic Varicose Veins Treated With Vascular Plugs Type Am... | NCT04115137

Studies
Pelvic Varicose Veins Treated With Vascular Plugs Type Amplatzer: REPiVAC

NCT04115137

Sponsor

Group of Research in Minimally Invasive Techniques

Status

Unknown status

Last Update Posted

Oct 3, 2019Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Pelvic Congestion Syndrome
Pelvic Varicose Veins
Follow-up Study
Embolization, Therapeutic
Observational Study

Interventions

pelvic varicose veins plug embolization

Countries

Spain

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

Oct 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

Mar 1, 2019Actual

Primary Completion Date

Nov 1, 2019Estimated

Completion Date

Jan 1, 2021Estimated

First Submitted Date

Jul 11, 2019

First Submission Date that Met QC Criteria

Oct 2, 2019

First Posted Date

Oct 3, 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

Oct 2, 2019

Last Update Posted Date

Oct 3, 2019Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Spanish multicentric record to study the efficacy and safety of the treatment with plugs in Pelvic Congestion Syndrome.

Detailed Description

This is an prospective observational study of patients that have been treated with plugs (type Amplazer) at least one of the pelvic varicose veins.

Patients are recruited when the plug is implanted, and the investigators perfom a patients follow-up during 1, 3, 6, 12, 24 months

Conditions Module

Conditions

Pelvic Congestion Syndrome
Pelvic Varicose Veins
Follow-up Study
Embolization, Therapeutic
Observational Study

Keywords

Pelvic Congestion Syndrome
amplatzer vascular plug
Vascular plug
metallic embolization device
Chronic pelvic pain
embolization procedure

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women with pelvic congestion syndrome		Women older than 18 years At least 1 birth Present symptoms	Device: pelvic varicose veins plug embolization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pelvic varicose veins plug embolization	Device	pelvic varicose veins plug embolization	Women with pelvic congestion syndrome

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Embolization of pelvic varicose veins using AVP	39/5000 absence of symptoms and vaginal ultrasound	24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female < 18 years
Present symptomatology
At least one image diagnosis

Exclusion Criteria:

Female > 18
Non present symptomatology
Non diagnosis

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Women older than 18, minimun 1 bith

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Women older than 18 years , minimun 1 bith and with symptoms of pelvic congestion syndrome

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Miguel A De Gregorio, Ph.D.	Contact	+34976765768		mgregori@unizar.es
José A Guirola, M.D.	Contact	+34976556400	162984	joseandresguirola@gmail.com

Overall Officials

Name	Affiliation	Role
Miguel A De Gregorio, Ph.D.	Minimal Invasive Techniques Research Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lozano Blesa Universitary Hospital	Recruiting	Zaragoza	Aragon	50009	Spain

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