Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

December 22, 2014 updated by: Cook Group Incorporated
To assess the adequacy of an endometrial biopsy sample obtained using sonohysterography.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama City, Panama, 8C6Q1 JGW8N
        • Hospital Punta Pacifica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SonoBiopsy Catheter
Device: SonoBiopsy Catheter
Catheter utilized in dual role: sonohysterography and endometrial biopsy
Other Names:
  • Endometrial biopsy with sonohysterography
ACTIVE_COMPARATOR: Endometrial biopsy catheter
Device: Endometrial biopsy catheter
Endometrial sample obtained without the assistance of sonohysterography
Other Names:
  • Endometrial biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of adequate endometrial biopsies utilizing sonohysterography
Time Frame: 7 days
7 days
percentage of adequate endometrial biopsies collected without sonohysterography
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: Ricardo Mastellari, MD, Hospital Punta Pacifica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

October 17, 2013

First Submitted That Met QC Criteria

October 21, 2013

First Posted (ESTIMATE)

October 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 23, 2014

Last Update Submitted That Met QC Criteria

December 22, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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