Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

NCT01969396TerminatedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Cook Group Incorporated

Enrollment

2

Start Date

2013-10-01

Completion Date

2014-09-01

Study Type

INTERVENTIONAL

Official Title

Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

Interventions

SonoBiopsy CatheterEndometrial biopsy catheter

Conditions

MenorrhagiaEndometrial NeoplasmsPolycystic Ovary SyndromeUterine Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

percentage of adequate endometrial biopsies utilizing sonohysterography

Time frame: 7 days

percentage of adequate endometrial biopsies collected without sonohysterography

Time frame: 7 days

Locations

Hospital Punta Pacifica, Panama City, Panama

Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology