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20 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 Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis
Condition: Skin Diseases
5 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
6 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
7 Completed Hepatic Monitoring for Pazopanib
Condition: Carcinoma, Renal Cell
Interventions: Drug: Pazopanib use;   Drug: Use of sunitinib, bevacizumab, or sorafenib
8 Completed 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
Has Results
Pazopanib in Combination With Capecitabine in Patients With Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
Intervention: Drug: Pazopanib plus capecitabine
10 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
11 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
12 Terminated Efficacy and Safety Study of DP-b99 in Treating Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
Interventions: Drug: DP-b99;   Drug: Placebo
13 Recruiting Investigate the Effect of the CREON2000A on Asthma Control in Children With Mild to Moderate Persistent Asthma
Condition: Asthma
Interventions: Device: CREON2000A;   Device: Sham
14 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
15 Active, not recruiting Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)
Conditions: Chronic Myeloid Leukemia;   Ph+ Acute Lymphoblastic Leukemia
Intervention: Drug: Ponatinib
16 Completed Long-Term Safety Of DVS-233 SR In Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
Intervention: Drug: Desvenlafaxine Succinate
17 Completed Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone (OPAL)
Condition: Opioid-induced Bowel Dysfunction
Interventions: Drug: Lubiprostone;   Drug: Placebo
18 Recruiting Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer
Condition: Metastatic gpNMB Over-expressing Triple Negative Breast Cancer
Interventions: Drug: CDX-011;   Drug: Capecitabine
19 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
20 Completed
Has Results
A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee
Condition: Osteoarthritis
Interventions: Drug: SD-6010;   Drug: Placebo

Study has passed its completion date and status has not been verified in more than two years.