Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

N/ATerminatedNCT01969396

Cook Group Incorporated2 enrolled

Overview

To assess the adequacy of an endometrial biopsy sample obtained using sonohysterography.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Menorrhagia Endometrial Neoplasms Polycystic Ovary Syndrome Uterine Neoplasms

Interventions

SonoBiopsy CatheterDEVICE

Catheter utilized in dual role: sonohysterography and endometrial biopsy

Endometrial biopsy catheterDEVICE

Endometrial sample obtained without the assistance of sonohysterography

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Punta Pacifica

Panama City, Panama

Outcomes

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

Data from ClinicalTrials.gov

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