Clinical Trials Logo
  1. Home
  2. Polycystic Ovary Syndrome
  3. NCT01969396
  4. Details
NCT01969396 Clinical Trial

Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

Polycystic Ovary Syndrome Clinical Trial

Official title:
Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01969396
Other study ID # 12-012
Secondary ID
Status Terminated
Phase N/A
First received October 17, 2013
Last updated December 22, 2014
Start date October 2013
Est. completion date September 2014

Study information
Verified date December 2014
Source Cook
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Intervention

Device:
• SonoBiopsy Catheter
Catheter utilized in dual role: sonohysterography and endometrial biopsy
• Endometrial biopsy catheter
Endometrial sample obtained without the assistance of sonohysterography

Locations
Country Name City State
Panama Hospital Punta Pacifica Panama City

Sponsors (1)
Lead Sponsor Collaborator
Cook

Country where clinical trial is conducted

Panama, 

Outcome
Type Measure Description Time frame Safety issue
Primary percentage of adequate endometrial biopsies utilizing sonohysterography 7 days No
Primary percentage of adequate endometrial biopsies collected without sonohysterography 7 days No
See also
  Status Clinical Trial Phase
Completed NCT03142633 - MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
Completed NCT06158932 - A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Completed NCT04932070 - Berberine and Polycystic Ovary Syndrome N/A
Suspended NCT03652987 - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed NCT03480022 - Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS Phase 3
Active, not recruiting NCT03043924 - Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS) N/A
Completed NCT05246306 - Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS
Completed NCT05981742 - Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS Phase 2
Completed NCT05702957 - Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome Phase 2/Phase 3
Completed NCT05029492 - Effect of Visceral Manipulation on PCOS N/A
Not yet recruiting NCT02255578 - Endobarrier Treatment in Women With PCOS Phase 3
Completed NCT02924025 - Motivational Interviewing as an Intervention for PCOS N/A
Not yet recruiting NCT00883259 - Metformin and Gestational Diabetes in High-risk Patients: a RCTs Phase 4
Completed NCT02098668 - Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON N/A
Withdrawn NCT01638988 - Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin Phase 3
Completed NCT01462864 - Development of a Structured Education Programme for Women With Polycystic Ovary Syndrome N/A
Recruiting NCT01431352 - Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS) N/A
Completed NCT00989781 - Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome N/A