Therapeutic Areas

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Center Overview

University Urology Associates is a private urology practice with a dedicated research site proficient in Phase II-IV clinical trials, under the supervision of Dr. Jed Kaminetsky, a Board Certified Urologist. University Urology is located in New York City, a large metropolitan area. Our location allows for us to partner with many other private practice physicians to augment recruitment of subjects. Additionally, we have a robust outreach program to further assist with recruitment of subjects. Our extensive industry experience enables us to offer our sponsors a quality research site with a trained and experienced clinical research team.

Clinical Research Experience

Experience in + 100 Clinical Research Trials involving the following therapeutic areas:

• Benign Prostatic Hyperplasia (BPH)
• Chronic & Acute Prostatitis
• Ejaculatory Dysfunction (low volume, low quality, & delayed ejaculation)
• Erectile Dysfunction (ED)
• Female Sexual Dysfunction / Hypoactive Sexual Desire Disorder
• Genital Warts
• High Grade Prostatic Intraepithelial Neoplasia
• Hypogonadism (low testosterone)
• Interstitial Cystitis
• Nocturia (nighttime urination)
• Overactive Bladder (OAB)
• Peyronies Disease (penile curvature)
• Premature Ejaculation (PE)
• Prostate Cancer & Bladder Cancer
• Urinary Incontinence (unwanted urinary leakage)

Sponsors:

Facility Description

University Urology is an outpatient facility located in Midtown Manhattan. Our equipment and capabilities include:

• Access to dry ice
• Access to local surgical center
• Centrifuge
• Electronic database of potential subjects
• Greenlight laser capabilities
• Medtronic urodynamic equipment
• Phlebotomy completed on site
• Portable bladder scan
• Radiology Facility
• Relationship with local ophthalmologist, internist, and GYN
• Semen analysis facility
• Temperature monitored Secure Drug Storage (ambient and refrigerated)
• Trans Rectal Ultrasound
• Ultrasound Machine
• Urodyn 1000 Uroflow machine
• Video Cystoscopy
• 12 lead EKG

Investigator Experience

Dr. Jed Kaminetsky, M.D. is a Clinical Associate Professor at New York University Medical Center, Associate medical Director of Gramercy Surgical Centre and is a practicing urologist with University Urology Associates, one of the largest urologic practices in the New York City metropolitan area. He is a board certified urologist and is highly skilled in treating all urologic disorders, performing minimally invasive prostate surgeries and penile implants. Dr. Kaminetsky's academic interests include the study of both male and female sexual dysfunction, which has led him to become a national and world thought leader. Dr. Kaminetsky work has been published in several journals which led to a nationwide recognition and development of various treatment schemes for patients with sexual, erectile dysfunction and androgen deficiency. Moreover, Dr. Kaminetsky is an experienced principal investigator who participates in national research studies that explore pharmacologic and diagnostic techniques for various urologic disorders. He is currently conducting studies addressing premature ejaculation, ED, male and female sexual dysfunction, BPH, prostate cancer, bladder cancer, voiding dysfunction, and hypogonadism. His hospital appointments include New York University Medical Center, New York Downtown Medical Center. Dr. Kaminetsky has been consulting for several pharmaceutical companies including Slate, Pfizer, Auxilium, Lilly, GlaxoSmithKline and American Medical Systems.

Staff Expertise

Betsy Ortiz Moclair, RN, CCRC, BSN is the Clinical Trials Director and registered nurse for University Urology Associates. Betsy has over 15 years of experience in clinical research. Her responsibilities include directing and conducting all managerial and operational aspects of all clinical trials. In addition to clinical research, she obtains a thorough medical history for incoming new patients. Betsy works in close contact with all the principal investigators, including Dr. Kaminetsky, to ensure that all patients are receiving the best quality of care. She has been actively involved in over 100 clinical trials.

University Urology Associates has a full-time ACRP Certified Clinical Trials Manager/CCRC, a Certified Clinical Research Coordinator, a study enrollment recruiter, and two research assistants. The staff is experienced in working with Sponsors, CROs, and the Central IRB to ensure integrity of study, patient safety, accurate data collection, and timely document submission.

Our study team is fully trained and up to date in the handling and shipping of biological/biohazard substances in accordance with U.S. Department of Transportation (DOT) and International Air Transportation Association (IATA) Dangerous Goods Regulations.

Furthermore, each member of our study staff has received formal training in:

• HIPPA Regulations
• Good Clinical Practices (GCP)
• OSHA Regulations
• NIH Protecting Human Research Participants

We are also proficient in a wide variety of electronic data capture systems, which include:

• Medidata Rave
• Target eCRF
• Inform
• Oracle RDC
• DSG eCaseLink
• EXPeRT Data Capture
• DATATRAK

Patient Demographics

Our location in Manhattan exposes us to a wide variety of patient demographics. New York City is the largest city in the United States with a population of more than 8 million people. This allows for compliance with FDA standards for ethnically and racially diverse subject expectations. We are centrally located and in close proximity to public transportation allowing for easy access for our subjects and sponsors visits.

Other Information

University Urology Associates utilizes a Central IRB. Regulatory documents are completed within 5 days, allowing for a quick turnaround. All case report data is entered shortly after subject visit has been completed. In addition, we frequently check all data systems on a daily basis, allowing for a fast turnaround of query resolution.

Contact Center

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the email form below. A representative from the research center will then follow up with you.