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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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