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Trial record 29 of 280 for:    Panama

Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

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ClinicalTrials.gov 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
Sponsor:
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

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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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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Responsible Party: Cook Group Incorporated
ClinicalTrials.gov 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:
Biopsy
Endometrial biopsy
Endometrial sampling
sonohysterography
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Endometrial Neoplasms
Uterine Neoplasms
Menorrhagia
Neoplasms
Ovarian Cysts
Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Uterine Hemorrhage
Uterine Diseases
Hemorrhage
Pathologic Processes
Menstruation Disturbances
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site