Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

NCT ID: NCT01969396

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-09-30

Brief Summary

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

Detailed Description

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Conditions

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Menorrhagia Endometrial Neoplasms Polycystic Ovary Syndrome Uterine Neoplasms

Keywords

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Biopsy Endometrial biopsy Endometrial sampling sonohysterography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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SonoBiopsy Catheter

Group Type EXPERIMENTAL

SonoBiopsy Catheter

Intervention Type DEVICE

Catheter utilized in dual role: sonohysterography and endometrial biopsy

Endometrial biopsy catheter

Group Type ACTIVE_COMPARATOR

Endometrial biopsy catheter

Intervention Type DEVICE

Endometrial sample obtained without the assistance of sonohysterography

Interventions

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SonoBiopsy Catheter

Catheter utilized in dual role: sonohysterography and endometrial biopsy

Intervention Type DEVICE

Endometrial biopsy catheter

Endometrial sample obtained without the assistance of sonohysterography

Intervention Type DEVICE

Other Intervention Names

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Endometrial biopsy with sonohysterography Endometrial biopsy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ricardo Mastellari, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Punta Pacifica

Locations

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Hospital Punta Pacifica

Panama City, , Panama

Site Status

Countries

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Panama

Other Identifiers

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12-012

Identifier Type: -

Identifier Source: org_study_id