Trial record 5 of 366 for:    Open Studies | "Uterine Neoplasms"

Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01969396
First received: October 17, 2013
Last updated: July 22, 2014
Last verified: July 2014
  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 Blind (Subject)
Official Title: Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • percentage of adequate endometrial biopsies utilizing sonohysterography [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • percentage of adequate endometrial biopsies collected without sonohysterography [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: June 2015 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01969396

Contacts
Contact: Teresa Woolard 765-463-7537 twoolard@medinst.com

Locations
Panama
Hospital Punta Pacifica Recruiting
Panama City, Panama, 8C6Q1 JGW8N
Contact: Rafael Pretto, MD    507-204-8001    IRB@HPP.COM.PA   
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Ricardo Mastellari, MD Hospital Punta Pacifica
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01969396     History of Changes
Other Study ID Numbers: 12-012
Study First Received: October 17, 2013
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cook:
Biopsy
Endometrial biopsy
Endometrial sampling
sonohysterography

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

ClinicalTrials.gov processed this record on July 29, 2014