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NCT01969396 Clinical Trial

Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

Polycystic Ovary Syndrome Clinical Trial

Official title:
Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01969396
Other study ID # 12-012
Secondary ID
Status Terminated
Phase N/A
First received October 17, 2013
Last updated December 22, 2014
Start date October 2013
Est. completion date September 2014

Study information
Verified date December 2014
Source Cook
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Intervention

Device:
• SonoBiopsy Catheter
Catheter utilized in dual role: sonohysterography and endometrial biopsy
• Endometrial biopsy catheter
Endometrial sample obtained without the assistance of sonohysterography

Locations
Country Name City State
Panama Hospital Punta Pacifica Panama City

Sponsors (1)
Lead Sponsor Collaborator
Cook

Country where clinical trial is conducted

Panama, 

Outcome
Type Measure Description Time frame Safety issue
Primary percentage of adequate endometrial biopsies utilizing sonohysterography 7 days No
Primary percentage of adequate endometrial biopsies collected without sonohysterography 7 days No
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