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Non-Oncology Clinical Trials

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

INTERVENTIONAL CARDIOLOGY

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

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)

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

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

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

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

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

 SMMC 13-018:  EXPANDED ACCESS IND FECAL MICROBIAL TRANSPLANTATION

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
  • Clinical Coordinator: Kathryn Kay
  • For additional information, email kkay@stmaryhealthcare.org

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

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

EMERGENCY DEPARTMENT

  • Presently there are no protocols available at SMMC

ELECTROPHYSIOLOGY

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

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

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

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

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

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

 

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

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

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

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

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

SMMC 11-023: Neuroform Microdelivery Stent System

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

 

INFECTIOUS DISEASE

 SMMC 13-018:  EXPANDED ACCESS IND FECAL MICROBIAL TRANSPLANTATION

OBESITY

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

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

  

PULMONARY

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

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

 

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.