Fibroid Ablation Study - Large Fibroids | NCT01539187

Studies
Fibroid Ablation Study - Large Fibroids

NCT01539187

Sponsor

Gynesonics

Status

Terminated

Last Update Posted

Mar 17, 2015Estimated

Enrollment

6Actual

Phase

Not Applicable

Conditions

Leiomyoma
Uterine Fibroids
Menorrhagia

Interventions

VizAblate System

Countries

Mexico
Netherlands
United Kingdom

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

Mar 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Investigational device changes

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Feb 21, 2012

First Submission Date that Met QC Criteria

Feb 24, 2012

First Posted Date

Feb 27, 2012Estimated

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

Mar 13, 2015

Last Update Posted Date

Mar 17, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

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

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VizAblate intervention	Experimental	VizAblate System with subject serving as her own control	Device: VizAblate System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VizAblate System	Device	VizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean percentage change in target fibroid perfused volume		Baseline, 3 months, 12 months

Secondary Outcomes

Measure	Description	Time Frame
Number of adverse events	Procedure safety will be assessed by recording all adverse events that occur on the day of the procedure. Longer-term safety will be assessed by recording at each follow-up visit any untoward medical occurrence since baseline. Each adverse event will be assessed for severity and relationship to study device.	Procedure through 12 mo

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

28 years of age or older
Consistent menstrual cycles
History of excessive bleeding for at least 3 months
Baseline UFS-QOL Symptom severity score ≥ 20
At least one target fibroid having a maximum diameter > 5cm and ≤ 10 cm
Not at material risk for pregnancy
Willingness to participate, adhere to follow-up requirements, and sign the informed consent form
Willing to have uniform maintenance of antifibrinolytic or non steroidal anti-inflammatory agents
Menstrual Pictogram score ≥ 120 during a one-month screening period.

Exclusion Criteria:

Presence of type 0 intracavitary fibroids
Target fibroid > 10cm in maximum diameter
Abnormality of the endometrial cavity that obstructs access of the treatment device
Postmenopausal
Desire for current or future fertility
Hemoglobin < 6 g/dl
Evidence of disorders of hemostasis
Use of GnRH agonist or depomedroxyprogesterone acetate or other implantable or injectable progestin and/or estrogen, SERM or SPRM within the last 6 months prior to screening
Evidence for current cervical dysplasia (CIN II or greater)
Endometrial hyperplasia
Confirmed abdominal / pelvic malignancy within previous five years
Active pelvic infection or positive screen for pelvic gonorrhea or chlamydia
Clinically significant adenomyosis
Previous uterine artery embolization
Previous surgical or ablative treatment for fibroids or menorrhagia within 12 months prior to screening
Current use of anticoagulant therapy
Major medical or psychiatric illness affecting general health or ability to adhere to follow-up
Contraindication to MRI
Renal insufficiency
Uncontrolled hypertension lasting 2 years or more
Calcified fibroids
Presence of extrauterine pelvic mass
Presence of tubal implant for sterilization
Previous pelvic irradiation
Endometrial cavity length < 4.5 cm

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

28 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Universidad Autonoma de Nuevo Leon (UANL)		Monterrey	Nuevo León	64460	Mexico
Maxima Medisch Centrum

ID	Term
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D007889	Leiomyoma
D008595	Menorrhagia