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Clinical Trials at St. Mary

Non-Oncology Clinical Trials

 

(updated 7/14/14) 

CARDIOLOGY

 

SMMC 14-010: RELAX: CLINICAL TRIAL PROTOCOL CRLX030A2301 A multicenter, randomized, double-blind, placebo controlled phase IIIb study to evaluate the efficacy, safety and tolerability of Serelaxin when added to standard therapy in acute heart failure patients

  • Principal Investigator:  Rakesh      Shah, MD
  • Clinical      Coordinator:  Marci Campbell, RN,      BSN, CCRP
  • For additional      information, email researchinstitute@stmaryhealthcare.org

 

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INTERVENTIONAL CARDIOLOGY

 

SMMC 06-016: Closure of Patent Foramen Ovale with PFO ACCESS Registry

  • Principal Investigator:  Rakesh Shah, MD

 

SMMC 11-010: ORBIT II: Pivotal Trial to Evaluate the Safety and Efficacy of the Diamondback 360°® Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary Lesions (ORBIT II)

  • Principal Investigator:  Rakesh      Shah, MD

 

SMMC 11-012: IONTM Paclitaxel-Eluting Coronary Stent System US Post-Approval Stent Study 

  • Principal Investigator:       George Heyrich, MD

 

SMMC 11-026: ALERTS - AngeLmed for Early Recognition and Treatment of Stemi Study

  • Principal      Investigator:  Rakesh Shah, MD

 

SMMC 13-007: ABSORB Randomized Controlled Trial (RCT) to evaluate the safety and effectiveness of the Abbott Vascular Absorb Bioresorbable Vascular Scaffold (BVS) System.

  • Principal Investigator:       George Heyrich, MD

 

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CARDIOTHORACIC / CRITICAL CARE

 

SMMC 13-014:  IP-0009-12 Bolton Medical, Inc Post-Approval Study of the Relay Thoracic Stent-Graft with Plus Delivery System in Patients with Thoracic Aortic Aneurysms and Penetrating Ulcers

  • Principal Investigator:  David      Drucker, MD

 

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CRITICAL CARE

 

SMMC 13-014:  IP-0009-12 Bolton Medical, Inc Post-Approval Study of the Relay Thoracic Stent-Graft with Plus Delivery System in Patients with Thoracic Aortic Aneurysms and Penetrating Ulcers

  • Principal Investigator:  David      Drucker, MD

 

SMMC 13-018:  EXPANDED ACCESS IND FECAL MICROBIAL TRANSPLANTATION

  • Principal Investigator:  Doanld      Marcus, MD

 

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ENDOCRINE / DIABETES MANAGEMENT

 

SMMC 10-008: TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control

  • Principal Investigator:       Horatio Hidalgo, MD

 

SMMC 12-001: ACROSTUDY - A Multicenter, Post-Marketing, Surveillance Study of Somavert Therapy in Patients with Acromegaly

  • Principal Investigator:  Alan      Schorr, DO

 

SMMC 12-007: Pivotal Aspiration Therapy with Adjusted Lifestyle (PATHWAY) Study

  • Principal Investigator:  Alan      Schorr, DO

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EMERGENCY DEPARTMENT

 

  • Presently there are no protocols available at SMMC

 

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ELECTROPHYSIOLOGY

 

SMMC 11-026: ALERTS - AngeLmed for Early Recognition and Treatment of Stemi Study

  • Principal      Investigator:  Rakesh Shah, MD

 

SMMC 11-026: MRI Study: Accent MRI™ Pacemaker and Tendril MRI™ Lead IDE Study:  ACCENT

  • Principal      Investigator:  Eran Zacks, MD

 

SMMC 13-006: ENTOVIS: PRO-MRI STUDY BY BIOTRONIK

  • Principal      Investigator:  Rafael Pena, MD

 

SMMC 13-009: SIELLO Clinical Study:  Safety and Performance Study of the Siello S Pacing Lead (SIELLO)

  • Principal      Investigator:  Steven Kutalek, MD

 

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GYNECOLOGY

 

SMMC 13-020: Protocol No. PR1205 A Prospective, Safety and Efficacy Cohort Study of Elevate® Anterior and Apical Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse Repair:  ELEVATE

  • Principal Investigator:  Stephanie      Molden, MD

 

SMMC 14-004: CAPTURE Registry Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices

  • Principal Investigator:       Stephanie Molden, MD

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HUMANITARIAN DEVICE EXEMPTIONS

 

SMMC 02-009:  JOSTENT® Coronary Stent Graft and JOSTENT® GraftMaster for the treatment of free perforation, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts ≥ 2.75 mm in diameter

  • Principal Investigator:  Ronald      Fields, MD

 

SMMC 06-016:  Closure of Patent Foramen Ovale with PFO ACCESS Registry

  • Principal Investigator:  Rakesh      Shah, MD

 

SMMC 07-001: OP-1 (HDE #H010002)

  • Principal      Investigator:  Bradley Fink, MD

 

SMMC 11-021: CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System

  • Principal Investigator:  Robert      Rosenwasser, MD

 

SMMC 11-022: Wingspan Stent System with Gateway PTA Balloon Catheter

  • Principal Investigator:  Robert      Rosenwasser, MD

 

SMMC 11-023: Neuroform Microdelivery Stent System

  • Principal Investigator:  Robert      Rosenwasser, MD

 

SMMC 12-002: Onyx Liquid Embolic System (Onyx HD-500)

  • Principal Investigator:  Robert      Rosenwasser, MD

 

 

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INFECTIOUS DISEASE

 

SMMC 13-018:  EXPANDED ACCESS IND FECAL MICROBIAL TRANSPLANTATION

  • Principal Investigator:  Doanld      Marcus, MD

 

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OBESITY

 

SMMC 12-007: Pivotal Aspiration Therapy with Adjusted Lifestyle (PATHWAY) Study

  • Principal Investigator:  Alan      Schorr, DO

 

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PEDIATRICS

 

Presently there are no protocols available at SMMC

 

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NEUROSURGICAL

 

Presently there are no protocols available at SMMC

 

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NEUROVASCULAR

 

SMMC 06-016:  Closure of Patent Foramen Ovale with PFO ACCESS Registry

  • Principal Investigator:  Rakesh      Shah, MD

 

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PULMONARY

 

SMMC 09-003:  Long-term Oxygen Treatment Trial (LOTT)

  • Principal Investigator:  Howard      Lee, MD
  • Research Advisor:  Mary      Iannacone, DO
  • For additional      information, email ianaconemary@yahoo.com

 

SMMC 11-002:  STATCOPE - Prospective Randomized Placebo-Controlled Trial of SimvaSTATin in the Prevention of COPD Exacerbations

  • Principal Investigator:  Howard      Lee, MD
  • Research Advisor:  Mary      Iannacone, DO
  • For additional      information, email ianaconemary@yahoo.com

 

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RENAL DISEASE

 

Presently there are no protocols available at SMMC

 

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VASCULAR INTERVENTION

 

Presently there are no protocols available at SMMC

 

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WOUND MANAGEMENT

 

Presently there are no protocols available at SMMC

 

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BECOMING A RESEARCH PARTICIPANT:

Someday, you or a family member may want to take part in a research study. If this happens, the information here may help you make the right decision.

What Is Research?

  • Research is a study that is done to answer a question.
  • Scientists do research because they don’t know for sure what works best to help you. They are working to determine the answer as to what is best.
  • Some other words that describe research are clinical trial, protocol, survey, or experiment.
  • Research is not the same as treatment.

Why Is Research Important?

Research has led to important discoveries that make our lives better. Some examples are:

  • New drugs to treat cancer, diabetes, and other diseases
  • Ultrasound, X-ray machines, and diagnostic tests
  • Vaccines
  • Ways to stop smoking
  • Improved medical procedures

These are some questions that you should ask before you agree to participate in a research study:

  • Why is the research being done?  What question are you trying to answer?
  • What will be done to me as part of the research?
  • How will I benefit from the research?
  • What other options do I have?
  • Could the research hurt me?
  • Have other studies like this one been done?
  • What will the researcher do with my information?
  • Will the research cost me anything?
  • Who pays if I’m unexpectedly injured in the study?
  • How long will the study last?  What do I have to do as far as office visits, medications, medical tests?
  • What happens if I decide to leave the study early?
  • Who should I call if I have a question about the research?

Points to Consider

  • A research study may or may not help you personally.
  • In the future, the results could help others who have a health problem.
  • Taking part in research is voluntary.

Before you decide to become a research volunteer, get the facts:

  • Know what you’re getting into.
  • Ask questions.
  • Learn as much as you can.
  • Know the pros and cons.