Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

Cook Group

Status: Terminated

Conditions: Uterine Neoplasms; Polycystic Ovary Syndrome; Menorrhagia; Endometrial Neoplasms

Treatments: Device: SonoBiopsy Catheter; Device: Endometrial biopsy catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT01969396

12-012

Details and patient eligibility

About

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

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

2 participants in 2 patient groups

SonoBiopsy Catheter

Experimental group

Treatment:

Device: SonoBiopsy Catheter

Endometrial biopsy catheter

Active Comparator group

Treatment:

Device: Endometrial biopsy catheter