Clinical trials: Multicenter Prospective Study
Polyp of Colon, Endoscopic Mucosal Resection
EndoRotor® Endoscopic Mucosal Resection System for the Colon
The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic…
- Conditions
- Polyp of Colon, Endoscopic Mucosal Resection, Recurrent Colon Adenoma
- Trial name
- NCT04203667
- Testing
- EndoRotor Resection
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 66 people
- Sponsor
- Interscope, Inc.
Cataract
Assessment of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery
The purpose of this research study is to evaluate the clinical outcomes of the use of low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens…
- Trial name
- NCT04747834
- Testing
- MICOR-304
- Where
- 3 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Carl Zeiss Meditec, Inc.
Breast Cancer
Immediate Postmastectomy Breast Reconstruction (Strattice Breast)
This prospective, multicenter, open-label study will assess the clinical outcomes of the LTM product in three planned analyses. The primary objective of this study is to prospectively assess the clinical outcomes associated with…
- Trial name
- NCT00619762
- Testing
- LTM - a porcine-based surgical mesh
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- LifeCell
Advanced Breast Cancer
Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment
The purpose of this study was to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or…
- Trial name
- ALPINIST (NCT05631795)
- Testing
- Alpelisib, Fulvestrant
- Where
- 12 sites in India
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Décolleté Wrinkles
Investigation of the Effectiveness and Safety of MRZF111 in the Treatment of Décolleté Wrinkles
To evaluate the effectiveness and safety of MRZF111 treatment for improvement of décolleté wrinkles as assessed on the Merz Aesthetics Scales (MAS) Décolleté Wrinkles-At Rest.
- Trial name
- NCT04177212
- Testing
- MRZF111
- Where
- 9 sites in Germany
- Volunteers
- 117 people
- Sponsor
- Merz Aesthetics GmbH
Partial Edentulism, Complete Edentulism
Immediate Function of NobelSpeedy Shorty and Brånemark System® Mk III Shorty Implants in Daily Use
The aim of this study was to evaluate the 7 mm long implants NobelSpeedy Shorty and Brånemark System Mk III Shorty: by determining the marginal bone remodeling, implant survival rate, soft tissue health and maintenance.
- Trial name
- NCT02180230
- Testing
- Shorty implants
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Nobel Biocare
Femoral Arteriotomy Closure
MANTA Ultrasound Closure Study
Demonstrate the safety of MANTA Vascular Closure Device (VCD) ultrasound (U/S) guided closure in patients undergoing elective TAVR procedures with planned percutaneous femoral arterial access.
- Trial name
- MANTA ULTRA (NCT05142566)
- Testing
- MANTA Vascular Closure Device
- Where
- 6 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- Essential Medical, Inc.
Acute Otitis Externa, Swimmer's Ear
Phase 3 Study of OTO-201 in Acute Otitis Externa
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201…
- Trial name
- NCT02801370
- Testing
- 12 mg ciprofloxacin
- Where
- 2 sites in United States, Canada
- Volunteers
- 262 people
- Sponsor
- Otonomy, Inc.
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)
A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)
The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT associated with stage 5 CKD receiving Peritoneal…
- Trial name
- NCT04064827
- Testing
- Paricalcitol
- Where
- 15 sites in United States, Puerto Rico
- Volunteers
- 2 people
- Sponsor
- AbbVie
Rotator Cuff Injuries, Shoulder Pain
ASHCOM Shoulder System and Its Related Instruments
The objectives of this study are to confirm safety, performance and clinical benefits of the ASHCOM Shoulder System and its related instruments by analysis of standard scoring systems, radiographs and adverse event records.
- Conditions
- Rotator Cuff Injuries, Shoulder Pain, Arthropathy; Traumatic, Arthroplasty Complications
- Trial name
- NCT04258605
- Testing
- ASHCOM Shoulder System
- Where
- Italy
- Volunteers
- 24 people
- Sponsor
- Zimmer Biomet
Non-valvular Atrial Fibrillation
WAVECREST Post Market Clinical Follow-Up (PMCF) Study
The WAVECREST PMCF Study is a prospective, non-randomized, multicenter study to confirm safety and performance of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System in the current medical practice setting in…
- Trial name
- NCT03204695
- Testing
- Percutaneous LAA Closure, Anticoagulation or Clopidogrel
- Where
- Belgium
- Volunteers
- 27 people
- Sponsor
- Coherex Medical
Oropharyngeal Cancer
Prospective, Multicenter da Vinci® SP™ Surgical System TORS Study
A prospective, multicenter investigation of the da Vinci® SP™ Surgical System in Transoral Robotic Surgery (TORS) procedures for malignant oropharyngeal tumors.
- Trial name
- NCT03049280
- Testing
- Transoral robotic surgery
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- Intuitive Surgical
Otitis Externa
OTO-201 for the Treatment of Otitis Externa
This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear.
- Trial name
- NCT02511561
- Testing
- OTO-201 (ciprofloxacin)
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Otonomy, Inc.
Primary Immunodeficiency Disease
Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID
This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in treating patients with Primary Immunodeficiency (PID)
- Trial name
- NCT02810444
- Testing
- IgG Next Generation (BT595)
- Where
- 19 sites in United States, Germany and 3 more
- Volunteers
- 81 people
- Sponsor
- Biotest
Knee Pain, Chronic Osteoarthritis
ROSA Total Knee Post Market Study EMEA
This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of surgical workflow efficiency, patient pain and function outcome and adverse events data.
- Conditions
- Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus or Flexion Deformities
- Trial name
- NCT04338893
- Testing
- Device: Persona Total Knee, Device: NexGen Total Knee, Device: Vanguard Total Knee
- Where
- 6 sites in Belgium, Germany and 3 more
- Volunteers
- 252 people
- Sponsor
- Zimmer Biomet
Osteoarthritis, Rheumatoid Arthritis
Persona TM Tibia Clinical Outcomes Study
The primary objective of this study is to evaluate clinical performance for the commercially available Persona TM Tibia used in primary cementless tibia total knee arthroplasty.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis
- Trial name
- NCT03589300
- Testing
- Persona TM Tibia
- Where
- 7 sites in United States
- Volunteers
- 148 people
- Sponsor
- Zimmer Biomet
Postoperative Wound Infection
Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections
Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin.
- Trial name
- NCT00290290
- Testing
- chlorhexidine-alcohol, Povidone-Iodine
- Where
- 6 sites in United States
- Volunteers
- 849 people
- Sponsor
- Baylor College of Medicine
Open Angle Glaucoma, Ocular Hypertension
Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT
The objective of the study is to evaluate evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle…
- Trial name
- NCT02914509
- Testing
- Travoprost
- Where
- 10 sites in United States
- Volunteers
- 565 people
- Sponsor
- Ocular Therapeutix, Inc.
Pulmonary Arterial Hypertension
Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy
To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5 inhibitors (PDE-5i) therapy in pulmonary arterial hypertension (PAH) patients
- Trial name
- REPLACE (NCT02891850)
- Testing
- Riociguat (Adempas, BAY63-2521), Sildenafil, Tadalafil
- Where
- 81 sites in United States, Austria and 19 more
- Volunteers
- 225 people
- Sponsor
- Bayer
Tooth Disease, Partial Edentulism
A Prospective Study Evaluating the Performance of Nanotite Osseotite Implants When Placed by Graduate Student Programs
This study will evaluate the contributions of the Nanotite implant design when used by graduate students in their first year of placing implants.
- Trial name
- CollegeBowl (NCT00726063)
- Testing
- Nanotite dental implant, Osseotite dental implant
- Where
- United States
- Volunteers
- 241 people
- Sponsor
- ZimVie