St. Charles is Also Testing New Devises for Improved Medical and Surgical Care
At least 25 new medicasl devices are being tested at SCHS for improved patient care.  Many of these devices are iimplanted at surgery. 
Others are intensive care monitoring devices.  One is a new way to deliver radiation therapy that reduces 6-7 weeks of treatment in half.

Human Devices Approved via Human Device Exemption (HDE) by SCHS IRB for Use at SCHS

  Device Eponym Site Investigator Org. Description Expires
1 KAVIAR SCHS Ward, Brad MD The Center Kyphoplasty and Vertebroplasty in the Augmentation and Restoration of Vertebral Body Compression Fractures 2/24/2012
2 ASCENSION PIP SCHS Verheyden, James MD The Center Ascension PIP (Proximal Interphalangeal) Follow-Up Study, #CP-PIP-002, 10 FEB 2006. Ascension PIP Humanitarian Device #H010005. 6/15/2012
3 ASCENSION PIP IMPLANT SCHS Verheyden, James MD The Center Ascension® PIP Finger Implant 7/20/2012
4 TRIATHLON SCHS Buehler, Knute MD The Center Triathlon CR Outcomes Study: An open label, post-market, non-randomized, historical controlled, multi-center study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System 7/20/2012
5 ONYX SCHS Tien, Raymond MD, PhD The Center Onyx - HD500 Liquid Embolic System 8/24/2012
6 SAPPHIRE WW SCHS Tien, Raymond MD, PhD The Center Stenting and Angioplasty with Protection In Patients at High-risk for Endarterectomy SAPPHIRE WW - P06-3603. 8/24/2012
7 ENTERPRISE SCHS Tien, Raymond MD, PhD The Center CORDIS ENTERPRISE Vascular Reconstruction Device and Delivery System 9/21/2012
8 OP-1 IMPLANT SCHS Gingold, Brett MD Desert Ortho. OP-1 Implant HDE# H010002 12/14/2012
9 AXXENT PBI SCHS Chang, Linyee MD SCHS XOFT's Axxent Balloon Partial Electronic Brachytherapy System for Stage 0 and I Breast Cancer 12/14/2012
10 OP-1 IMPLANT SCHS Gingold, Brett MD Desert Ortho. OP-1 Implant HDE# H010002 12/14/2012
11 OP-1 PUTTY SCHS Moore, Kathleen MD Desert Ortho. OP-1 Putty 12/14/2012
12 CHOICE SCHS Tien, Raymond MD, PhD The Center Carotid Stenting For High Surgical Risk Patients; Evaluating Outcomes Through The CollectIon Of Clinical Evidence (“CHOICE”) 1/25/2013
13 MEDTRONIC CAPS SCHS Tien, Raymond MD, PhD The Center A Prospective, Randomized, Controlled Multicenter Pivotal Clinical Trial of the Arthifical Cervical Disc-LP at Two Levels fo Symptomatic Cervical Disc Disease. #G050202, 03/27/06. 1/25/2013
14 PROPPE SCHS Neeb, Andrew D. MD Bend Urology Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration (PROPPER) ER1005 2/9/2013
15 COFLEX SCHS Tien, Raymond MD, PhD The Center Pivotal IDE Study of the coflex™ A study of an Investigational Non-fusion Spine Stabilization Device 3/14/2013
16 APACS SCHS Gorman, Susan MD Women's Ctr Adiana Post-Approval Clinical Study 3/14/2013
17 COFLEX SCHS Tien, Raymond MD, PhD The Center Pivotal IDE Study of the coflex™ A study of an Investigational Non-fusion Spine Stabilization Device 3/14/2013
18 JOSTENT SCHS McLellan, Bruce A MD SCHS Jostent Graftmaster 3/14/2013
19 XIAFLEX SCHS Verheyden, James MD The Center Retrospective Data review of Xiaflex Injections in Dupytren's Contracture 3/27/2013
20 INTACS-SCHS SCHS Stevens, Scott MD Bend Ophth. Use of 0.4 and 0.45 INTACS for Kertoconus (HDE No: HO40002 04-27-10) 5/2/2013
21 NEUROFORM SCHS Tien, Raymond MD, PhD The Center Neuroform Microdelivery Stent System, Humanitarian Device Exemption (HDE) 5/16/2013
22 SIMPLICITI SCHS Jacobson, Scott MD The Center Simpliciti (TM) IDE Trial 5/16/2013
23 ASCENSION MCP SCHS Verheyden, James MD The Center Ascension MCP Finger Implant Post-Approval Study, PyroCarbon Metacarpophalangeal Joint Prosthesis. Clinical Study Protocol #CP-MCP-002, Revision B. 5/16/2013
24 COAST SCHS Ward, Brad MD The Center Kyphon LSS-006-COA – Condition of Approval Study Treatment of Lumbar Spinal Stenosis with X-STOP IPD in Moderately Symptomatic Patients 5/16/2013
25 NEUROFORM SCHS Tien, Raymond MD, PhD The Center Neuroform Microdelivery Stent System, Humanitarian Device Exemption (HDE) 5/16/2013
26 SIMPLICITI SCHS Jacobson, Scott MD The Center Simpliciti (TM) IDE Trial 5/16/2013
27 WINGSPAN SCHS Tien, Raymond MD, PhD The Center Wingspan Stent System with Gateway PTA Balloon Catheter, HUD #03-0101 5/17/2013
  Testing Completed         Date Closed
28 LDR-ROI SCHS Belza, Mark MD The Center Clinical and radiographic outcomes of anterior cervical interbody fusion using a novel stand-alone interbody fusion device - (ROI-C) A prospective, non-randomized, multi-centered study 5/20/2011
29 INTRACEPT SCHS Belza, Mark MD The Center US Registry Study of the INTRACEPT™ System in the Treatment of Low Back Pain 5/20/2011
30 VEST-PREDICTS SCHS Laughlin, James SCHS The Vest Prevention of Early Sudden Death Trial (VEST) PREDiction of ICD Therapies Study (PREDICTS) 3/16/2010
31 GEM OS1 SCHS Hinz, Anthony MD The Center A Prospective, Randomized, Controlled Multi-center, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of GEM OS1 Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions 3/16/2010
32 OP-1 SCHS Yundt, Kent MD NW Brain&Sp OP-1 Putty FDA Humanitarian Use Device Exemption 2/20/2009
33 EXIBTR SCHS Chang, Linyee MD SCHS EXIBTrial and Registry: EBT for Treatment of Early Stage Breast Cancer 12/19/2008
34 AGREE SCHS Archer, Stephen MD, FACS Adv. Spc. Care A Pilot Study of the Effects of BYETTA (Exenatide) on Weight Loss in Morbidly Obese Patients Following Adjustable Gastric Banding (After Gastric Restriction on the Effects of Exenatide) 4/15/2008
35 OP-1 PUTTY SCHS Smith, Carla The Center OP-1 Putty 4/15/2008
36 CURRENT / OASIS 7 SCHS McLellan, Bruce A MD SCHS Randomized, multinational, double-blind study, comparing a high loading dose regimen of clopidogrel versus standard dose in patients with unstable angina or non-ST segment elevation myocardial infarction managed with an early invasive strategy 1/22/2008
37 GEM OS1 SCHS Hinz, Anthony MD The Center A Prospective, Randomized, Controlled Multi-center, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of GEM OS1 Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions 1/22/2008
38 LFIT SCHS Thomas, Robert The Center An open-label, prospective, post-market, randomized, multi-center clinical evaluation of the LFIT™ (Low Ion Friction Treatment) Anatomic CoCr (Cobalt Chromium) Femoral Head with X3® insert 8/18/2007
39 RECORD 4 SCHS Buehler, Knute MD The Center Regulation of Coagulationoin Orthopedic Surgery to Prevent DVT and PE: a Controlled, Double-Blind, Randomized Study of BAY 59 7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement 7/16/2007
40 CECT SCHS Buehler, Knute MD The Center Deep Vein Thrombosis (DVT) Prevention in Total Hip Replacement: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH), March 9, 2006 5/15/2007
41 EXETER SCHS Buehler, Knute MD The Center A Single Center Study to Evaluate the Radiographic and Survivorship Analysis of the Exeter® Femoral Component. 12/19/2006
42 EXACT SCHS Tien, Raymond MD, PhD The Center The EXACT Study - Emboshield and Xact Post Approval Carotid Stent Trial using the Emboshield® BareWire™ Rapid Exchange Embolic and Xact® Rapid Exchange Carotid Stent System, #640-0063. 11/1/2005





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