Evaluation of the Goldstein SonoBiopsy™ Catheter for Diag... | NCT01969396

Studies
Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

NCT01969396

Sponsor

Cook Group Incorporated

Status

Terminated

Last Update Posted

Dec 23, 2014Estimated

Enrollment

2Actual

Phase

Not Applicable

Conditions

Menorrhagia
Endometrial Neoplasms
Polycystic Ovary Syndrome
Uterine Neoplasms

Interventions

SonoBiopsy Catheter
Endometrial biopsy catheter

Countries

Panama

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

Dec 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrollment considerations and current status of the clinical study

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Oct 17, 2013

First Submission Date that Met QC Criteria

Oct 21, 2013

First Posted Date

Oct 25, 2013Estimated

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

Dec 22, 2014

Last Update Posted Date

Dec 23, 2014Estimated

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

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SonoBiopsy Catheter	Experimental		Device: SonoBiopsy Catheter
Endometrial biopsy catheter	Active Comparator		Device: Endometrial biopsy catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SonoBiopsy Catheter	Device	Catheter utilized in dual role: sonohysterography and endometrial biopsy	SonoBiopsy Catheter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percentage of adequate endometrial biopsies utilizing sonohysterography		7 days
percentage of adequate endometrial biopsies collected without sonohysterography		7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with thickened endometrium
Abnormal uterine bleeding

Exclusion Criteria:

Pregnant
Active pelvic infection
Pelvic inflammatory disease
Blood clotting disorders
Sexually transmitted disease
Uterine perforation
Recent cesarean section

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ricardo Mastellari, MD	Hospital Punta Pacifica	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Punta Pacifica		Panama City		8C6Q1 JGW8N	Panama

Condition Browse Module

MeSH Terms

ID	Term
D008595	Menorrhagia
D016889	Endometrial Neoplasms
D011085	Polycystic Ovary Syndrome
D014594	Uterine Neoplasms

Ancestor Terms

ID	Term
D014592	Uterine Hemorrhage
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided