Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

• Sponsor: Cook Group Incorporated (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01969396
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Oct 1, 2013
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. percentage of adequate endometrial biopsies utilizing sonohysterography [7 days]

2. percentage of adequate endometrial biopsies collected without sonohysterography [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Punta Pacifica	Panama City		Panama	8C6Q1 JGW8N

Sponsors and Collaborators

• Cook Group Incorporated

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cook Group Incorporated
• ClinicalTrials.gov Identifier: NCT01969396
• Other Study ID Numbers: 12-012
• First Posted: Oct 25, 2013
• Last Update Posted: Dec 23, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Cook Group Incorporated: Biopsy; Endometrial biopsy; Endometrial sampling; sonohysterography
• Additional relevant MeSH terms: Neoplasms; Polycystic Ovary Syndrome; Endometrial Neoplasms; Uterine Neoplasms; Menorrhagia

Study Results

No Results Posted as of Dec 23, 2014