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19 studies found for:    u.s. pivotal trial
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Rank Status Study
1 Active, not recruiting
Has Results
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
Condition: Severe Aortic Stenosis
Interventions: Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI);   Device: Surgical Aortic Valve Replacement (SAVR)
2 Completed
Has Results
Esteem Totally Implantable Hearing System
Condition: Mild to Severe Sensorineural Hearing Loss
Intervention: Device: Esteem Totally Implantable Hearing System
3 Active, not recruiting Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon
Condition: Peripheral Arterial Disease
Interventions: Device: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter;   Device: EverCross Percutaneous Transluminal Balloon Catheter
4 Completed
Has Results
Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions
Condition: Coronary Artery Disease
Intervention: Device: Diamondback 360 Orbital Atherectomy System
5 Completed Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis
Condition: Skin Diseases
6 Withheld [Trial of device that is not approved or cleared by the U.S. FDA]
7 Completed Phase 3 Study of Walter Reed (WR) 279,396 and Paromomycin Alone for the Treatment of Cutaneous Leishmaniasis in Panama
Condition: Cutaneous Leishmaniasis
Interventions: Drug: WR 279,396;   Drug: Paromomycin
8 Recruiting A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A
Conditions: Congenital Bleeding Disorder;   Haemophilia A
Intervention: Drug: turoctocog alfa pegol
9 Completed Hepatic Monitoring for Pazopanib
Condition: Carcinoma, Renal Cell
Interventions: Drug: Pazopanib use;   Drug: Use of sunitinib, bevacizumab, or sorafenib
10 Completed
Has Results
Pazopanib in Combination With Capecitabine in Patients With Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
Intervention: Drug: Pazopanib plus capecitabine
11 Terminated Efficacy and Safety Study of DP-b99 in Treating Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
Interventions: Drug: DP-b99;   Drug: Placebo
12 Completed Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone (OPAL)
Condition: Opioid-induced Bowel Dysfunction
Interventions: Drug: Lubiprostone;   Drug: Placebo
13 Terminated A Multicenter Trial of the Efficacy and Safety of a New Formulation of Ibuprofen 800 mg Every 6 Hours in the Management of Postoperative Pain
Condition: Postoperative Pain
Interventions: Drug: Intravenous ibuprofen;   Drug: Saline solution
14 Completed Long-Term Safety Of DVS-233 SR In Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
Intervention: Drug: Desvenlafaxine Succinate
15 Completed Safety and Efficacy of Inhaled Insulin in Patients With Diabetes and Asthma or COPD
Conditions: Diabetes Mellitus;   Asthma;   Pulmonary Disease, Chronic Obstructive
Interventions: Drug: Human Insulin Inhalation Powder;   Drug: injected insulin
16 Active, not recruiting PONATINIB for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)
Conditions: Chronic Myeloid Leukemia (CML);   Ph+ Acute Lymphoblastic Leukemia (ALL)
Intervention: Drug: Ponatinib 45 mg QD
17 Terminated
Has Results
Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015
Condition: Back Pain Lower Back Chronic
Intervention: Drug: Buprenorphine transdermal patch
18 Recruiting Investigate the Effect of the CREON2000A on Asthma Control in Children With Mild to Moderate Persistent Allergic Asthma
Condition: Allergic Asthma
Interventions: Device: CREON2000A;   Device: Sham
19 Unknown  Comparison of Biofeedback vs. Botox Injection to Treat Levator Ani Syndrome
Condition: Levator Ani Syndrome With Pain and/or Constipation Symptoms.
Interventions: Behavioral: Biofeedback therapy;   Procedure: Botulinum Toxin Type A Injection

Indicates status has not been verified in more than two years