Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01969396

Enrollment

Registered

2013-10-25

Start date

2013-10-31

Completion date

2014-09-30

Last updated

2014-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Neoplasms, Menorrhagia, Polycystic Ovary Syndrome, Uterine Neoplasms

Keywords

Biopsy, Endometrial biopsy, Endometrial sampling, sonohysterography

Brief summary

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

Interventions

DEVICESonoBiopsy Catheter

Catheter utilized in dual role: sonohysterography and endometrial biopsy

DEVICEEndometrial biopsy catheter

Endometrial sample obtained without the assistance of sonohysterography

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Panama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026