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Non-Oncology Clinical Trials

Non-Oncology Clinical Trials

 (updated 12/22/14) 

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

 

SMMC 14-012: MARINER: Medically Ill Patient Assessment of Rivaroxaban Versus Placebo In Reducing Post-Discharge Venous Thrombo-Embolism Risk

  • Principal Investigator: George Heyrich, MD

 

SMMC 14-017: RE-VERSE-AD (A study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) trial

  • Principal Investigator: Ronald Fields, MD

 

INTERVENTIONAL CARDIOLOGY

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

  • Principal Investigator: Rakesh Shah, MD

 

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

 

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

 

ENDOCRINE / DIABETES MANAGEMENT

SMMC 14-015: BMS Clinical Protocol MB102229 A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects with Type 1 Diabetes Mellitus

  • Principal Investigator: Alan Schorr, DO

 

EMERGENCY DEPARTMENT

 

  • Presently there are no protocols available at SMMC

 

ELECTROPHYSIOLOGY

 

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

 

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

  • Principal Investigator: Rafael Pena, MD

 

GENERAL MEDICINE

SMMC 14-014: UPGRADE Utility of PharmacoGenomics for Reducing Adverse Drug Effects

  • Principal Investigator: Mrugesh Patel, MD

 

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

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 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

 

INFECTIOUS DISEASE

SMMC 13-018: EXPANDED ACCESS IND FECAL MICROBIAL TRANSPLANTATION

  • Principal Investigator: Doanld Marcus, MD

 

OBESITY

Presently there are no protocols available at SMMC

 

PEDIATRICS

Presently there are no protocols available at SMMC

 

NEUROSURGICAL

Presently there are no protocols available at SMMC

 

NEUROVASCULAR

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

  • Principal Investigator: Rakesh Shah, MD

 

SMMC 14-016: MaRiss: Mild and Rapidly Improving Stroke Study

  • Principal Investigator: Howard Natter, MD

 

PULMONARY

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

  • Principal Investigator: Howard Lee, MD

 

RENAL DISEASE

Presently there are no protocols available at SMMC

 

VASCULAR INTERVENTION

Presently there are no protocols available at SMMC

 

WOUND MANAGEMENT

Presently there are no protocols available at SMMC

 

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.