Clinical Trials Logo

Filter by:
NCT ID: NCT01421849 Withdrawn - Edentulous Clinical Trials

Mandibular Single Implant Overdenture: a Prospective Clinical Trial

Start date: August 2011
Phase: N/A
Study type: Interventional

Study hypothesis: that there would be no difference in patient satisfaction among institutionalised older people before and after treatment with a mandibular single implant-retained overdenture. In a preliminary phase, a new denture is made or the old denture is adapted to provide a well-fitting denture. Eight weeks after insertion of the new denture a single implant is placed in the centre of the mandibula. If the level of primary stability is sufficient to enable the implant to resist micromovement, the implant is immediately loaded . If not, the implant is loaded after 6 to 12 weeks. Primary stability is assessed by the final seating torque and by the clinician's interpretation and tactile sense of primary stability. Before, during and after the treatment patient satisfaction and clinical outcomes are evaluated by a 20 item questionnaire and a clinical examination.

NCT ID: NCT01357590 Withdrawn - Clinical trials for Aortic Aneurysm, Thoracic

Evaluation of Thoraflex in the Treatment of Aneurysm or Penetrating Ulcer of the Descending Thoracic Aorta

Start date: n/a
Phase: N/A
Study type: Interventional

ThoraflexTM is designed for the treatment of aneurysm or penetrating ulcer of the descending thoracic aorta. Each system is advanced from a transfemoral or transiliac approach over a 0.035" guidewire and positioned under fluoroscopic control. If necessary, an arterial conduit technique may be required to allow access to the arterial system. The soft tapered tip allows atraumatic insertion into the vessel, while the catheter and sheath are designed to provide excellent flexibility and control through tortuous arterial anatomy. Each individual stent graft device is supplied sterile and pre-loaded in a single-use delivery system. The stent graft is a self-expanding endoprosthesis constructed of a thin wall woven polyester and nitinol ring stents, which are attached to the fabric with braided polyester sutures. The delivery system central catheter is a stainless steel braided co-extrusion of polytetrafluoroethylene (PTFE) and polyester elastomer, designed to provide significant torque control and strength, while also maintaining superior flexibility. The outer sheath is made in a tri-layer construction consisting of a PTFE liner, a stainless steel flat braid layer and a polyester elastomer outer jacket with a hydrophilic lubricant coating. These materials provide very low friction force during device insertion and deployment together with enhanced flexibility of the delivery system. The handle components are moulded from thermoplastic polyurethane. The materials of the endoprosthesis are identical to those of the current Conformité Européenne (CE) marked Vascutek Ltd. AnacondaTM Stent Graft System intended for abdominal aortic aneurysm repair. The materials of the delivery system are well established in medical applications. The design of ThoraflexTM is based on the same principles as other clinically established thoracic endovascular devices. The endoprosthesis is constructed of self-expanding nitinol stents and a polyester tube graft. Four proximal hooks anchor the endoprosthesis within the aorta. Unlike existing thoracic endovascular devices, the delivery system of ThoraflexTM allows repositioning of the endoprosthesis so that the optimal deployment position can be enhanced. The intended use of ThoraflexTM is the treatment of aneurysm or penetrating ulcer of the descending thoracic aorta, which is identical to other CE approved thoracic endovascular devices.

NCT ID: NCT01282645 Withdrawn - Craniotomy Clinical Trials

Case Series to Evaluate Patient Specific Implants (PSI) in Polyether Ether Ketone (PEEK) Performance After 2 Years

Start date: July 2011
Phase: N/A
Study type: Observational

The primary objective of this retrospective study is to evaluate the percentage of patients with device related adverse events (infection, rejection, dislocation, fracture of the implant) in the first 24 months after implantation.

NCT ID: NCT01278511 Withdrawn - Clinical trials for Injury of Cervical Spine

Prospective Pilot Study Validating the Canadian C-Spine Rule Pre-hospital

Start date: January 2011
Phase: N/A
Study type: Interventional

This study is designed to evaluate the safety, level of performance and level of comfort with the Canadian C-Spine rule in a prehospital setting by emergency medicine undergraduates.

NCT ID: NCT01266811 Withdrawn - Multiple Myeloma Clinical Trials

A Phase 3 Study of Siltuximab or Placebo in Combination With Velcade and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Start date: July 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if there is an improvement in progression-free survival (length of time during and after treatment in which a patient is living with a disease that does not get worse) when siltuximab is added to VELCADE and dexamethasone in subjects with relapsed or refractory multiple myeloma.

NCT ID: NCT01264510 Withdrawn - Clinical trials for Conductive Hearing Loss

Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha)

Baha
Start date: March 2010
Phase: Phase 4
Study type: Interventional

A bone-anchored hearing aid (Baha) consists of a titanium implant located at the mastoid, and a sound processor connected with the implant. The sound processor delivers bone conducted stimuli to the cochlea, bypassing the outer and middle ear. Some patients who are unable to wear or do not benefit from a conventional air-conduction hearing aid, are candidate for a Baha. Typically, these patients suffer from a conductive or a mixed hearing loss. Recently however, Baha's are also being recommended in patients with unilateral deafness. Sound coming from the deaf side is captured and transmitted through bone conduction to the normal inner ear. The overall benefit of a Baha is more difficult to assess in those patients. Therefore, the goal of the current study is to examine the benefit of a Baha in patients with different audiological profiles (unilateral or bilateral conductive or mixed hearing loss, and unilateral deafness). Special attention will be given to predictive determinants of the benefit with a Baha, and to the improvement of pre-operative criteria and counseling of patients.

NCT ID: NCT01167335 Withdrawn - Clinical trials for Partial Onset Seizures

Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures

Start date: August 2010
Phase: Phase 2
Study type: Interventional

This study will assess the efficacy of BGG492 as adjunctive treatment in patients with refractory partial onset seizures

NCT ID: NCT01091233 Withdrawn - Liver Cirrhosis Clinical Trials

The Influence of Paracentesis on Intra-abdominal Pressure and Kidney Function in Critically Ill Patients With Liver Cirrhosis and Ascites: an Observational Study

Start date: March 2010
Phase:
Study type: Observational

Patients with liver cirrhosis are at risk for development of renal failure, usually after a precipitating event such as infection or bleeding. This form of renal failure has a high morbidity and mortality and may be partly caused by increased intra-abdominal pressure secondary to ascites. Recent studies have shown that paracentesis (and the resulting decreased IAP) can increase urinary output and decrease renal arterial resistive index in patients with hepatorenal syndrome (a very pronounced form of renal failure in cirrhosis patients). The aim of this study is to evaluate the influence of Paracentesis on intra-abdominal pressure and kidney function in critically ill patients with liver cirrhosis and ascites across a wider range of kidney function. Kidney function will be evaluated using several estimates of glomerular filtration rate and measures of kidney injury i.e. cystatin C, serum NGAL, creatinine clearance, urinary output and renal arterial resistive index.

NCT ID: NCT01077895 Withdrawn - Acute Kidney Injury Clinical Trials

The Influence of Fluid Removal Using Continuous Venovenous Hemofiltration (CVVH) on Intra-abdominal Pressure and Kidney Function

Start date: February 2010
Phase: Phase 3
Study type: Interventional

Intra- abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) are a cause of organ dysfunction in critically ill patients. IAH develops due to abdominal lesions (primary IAH) or extra-abdominal processes (secondary IAH). Secondary IAH arises due to decreased abdominal wall compliance and gut edema caused by capillary leak and excessive fluid resuscitation. Decreasing intra-abdominal pressure (IAP) using decompressieve laparotomy has been shown to improve organ dysfunction. However, laparotomy is generally avoided in patients with secondary IAH due to the risk of abdominal complications. Acute kidney injury (AKI) is one of the first and most pronounced organ failures associated with IAH and many patients with AKI in the ICU require renal replacement therapy (RRT). Fluid removal using continuous RRT (CRRT) has been demonstrated to decrease IAP in small series and selected patients. The aim of this study is to evaluate whether fluid removal using CVVH in patients with IAH, fluid overload and AKI is feasible and whether it has a beneficial effect on organ dysfunction (compared to CVVH without net fluid removal).

NCT ID: NCT00895791 Withdrawn - Clinical trials for Coronary Artery Stenosis

COmplex BifuRcation Lesions: A Comparison Between the AXXESS Device and Culotte Stenting: An Optical Coherence Tomography (OCT) Study

COBRA
Start date: June 2009
Phase: N/A
Study type: Interventional

The aim of this study is to compare vessel healing at 9 months using OCT imaging for two different treatment techniques for treating bifurcation lesions. Quantitative assessment of OCT images will be used to assess re-endothelialization and quality of strut apposition to the vessel wall.