Working… Menu
Trial record 29 of 280 for:    Panama

Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

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. Identifier: NCT01969396
Recruitment Status : Terminated (Enrollment considerations and current status of the clinical study)
First Posted : October 25, 2013
Last Update Posted : December 23, 2014
Information provided by (Responsible Party):
Cook Group Incorporated

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

Condition or disease Intervention/treatment Phase
Menorrhagia Endometrial Neoplasms Polycystic Ovary Syndrome Uterine Neoplasms Device: SonoBiopsy Catheter Device: Endometrial biopsy catheter Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology
Study Start Date : October 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01969396

Layout table for location information
Hospital Punta Pacifica
Panama City, Panama, 8C6Q1 JGW8N
Sponsors and Collaborators
Cook Group Incorporated
Layout table for investigator information
Principal Investigator: Ricardo Mastellari, MD Hospital Punta Pacifica

Layout table for additonal information
Responsible Party: Cook Group Incorporated Identifier: NCT01969396     History of Changes
Other Study ID Numbers: 12-012
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014
Keywords provided by Cook Group Incorporated:
Endometrial biopsy
Endometrial sampling
Additional relevant MeSH terms:
Layout table for MeSH terms
Polycystic Ovary Syndrome
Endometrial Neoplasms
Uterine Neoplasms
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Uterine Hemorrhage
Uterine Diseases
Pathologic Processes
Menstruation Disturbances
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site