Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

Not Applicable

Terminated

• Conditions: Menorrhagia; Endometrial Neoplasms; Polycystic Ovary Syndrome; Uterine Neoplasms
• Interventions: Device: SonoBiopsy Catheter; Device: Endometrial biopsy catheter

• Registration Number: NCT01969396
• Lead Sponsor: Cook Group Incorporated

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-17
• Study First Submitted QC: 2013-10-21
• Study First Posted: 2013-10-25
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-22
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SonoBiopsy Catheter	SonoBiopsy Catheter	-
Endometrial biopsy catheter	Endometrial biopsy catheter	-

Primary Outcome Measures

Name	Time	Method
percentage of adequate endometrial biopsies utilizing sonohysterography	7 days
percentage of adequate endometrial biopsies collected without sonohysterography	7 days

Trial Locations

Locations (1)

Hospital Punta Pacifica; 🇵🇦 Panama City, Panama