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Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

This study has been terminated.
(Enrollment considerations and current status of the clinical study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01969396
First Posted: October 25, 2013
Last Update Posted: December 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cook Group Incorporated
  Purpose
To assess the adequacy of an endometrial biopsy sample obtained using sonohysterography.

Condition Intervention
Menorrhagia Endometrial Neoplasms Polycystic Ovary Syndrome Uterine Neoplasms Device: SonoBiopsy Catheter Device: Endometrial biopsy catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

Resource links provided by NLM:


Further study details as provided by Cook Group Incorporated:

Primary Outcome Measures:
  • percentage of adequate endometrial biopsies utilizing sonohysterography [ Time Frame: 7 days ]
  • percentage of adequate endometrial biopsies collected without sonohysterography [ Time Frame: 7 days ]

Enrollment: 2
Study Start Date: October 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SonoBiopsy Catheter Device: SonoBiopsy Catheter
Catheter utilized in dual role: sonohysterography and endometrial biopsy
Other Name: Endometrial biopsy with sonohysterography
Active Comparator: Endometrial biopsy catheter Device: Endometrial biopsy catheter
Endometrial sample obtained without the assistance of sonohysterography
Other Name: Endometrial biopsy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969396


Locations
Panama
Hospital Punta Pacifica
Panama City, Panama, 8C6Q1 JGW8N
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Ricardo Mastellari, MD Hospital Punta Pacifica
  More Information

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01969396     History of Changes
Other Study ID Numbers: 12-012
First Submitted: October 17, 2013
First Posted: October 25, 2013
Last Update Posted: December 23, 2014
Last Verified: December 2014

Keywords provided by Cook Group Incorporated:
Biopsy
Endometrial biopsy
Endometrial sampling
sonohysterography

Additional relevant MeSH terms:
Neoplasms
Polycystic Ovary Syndrome
Menorrhagia
Endometrial Neoplasms
Uterine Neoplasms
Ovarian Cysts
Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Uterine Hemorrhage
Uterine Diseases
Menstruation Disturbances
Pathologic Processes
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site