Clinical trials: Delivery Systems
Contraception
KYleena Satisfaction Study / Observational Study on User Satisfaction With the Levonorgestrel Intrauterine Delivery System Kyleena (LNG-IUS 12) in New Contraceptive Users and After Switching From Another Contraceptive Method
The main goal of this non-interventional study (NIS) is to evaluate user satisfaction with Kyleena in a real-life setting and to identify factors which influence user satisfaction, taking into account previously used…
- Trial name
- KYSS (NCT03182140)
- Testing
- Kyleena
- Where
- 19 sites in United States, Belgium and 6 more
- Volunteers
- 1,134 people, healthy volunteers welcome
- Sponsor
- Bayer
Diabetes Mellitus
Evaluation of the Effects of Heating the Vicinity of the Insulin Delivery Site by the Experimental Device
The study is an open-label, randomized, two-period, one-way crossover study using the Meal Tolerance Test (MTT) protocol or the daily life setting protocol. The study consists of two parts.
- Trial name
- NCT02306343
- Testing
- InsuPad
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Insuline Medical Ltd.
Osteoarthritis
Buprenorphine in the Treatment of Osteoarthritis (OA) in the Elderly
The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).
- Trial name
- NCT00324038
- Testing
- Buprenorphine, Codeine paracetamol
- Where
- United Kingdom
- Volunteers
- 219 people
- Sponsor
- Napp Pharmaceuticals Limited
Diabetes, Diabetes Mellitus, Type 1
Evaluating the Use of Two Different Needles in Subjects With Diabetes
This trial is conducted in Europe. The aim of this trial is to compare two needle types when used with a disposable insulin injection pen in the everyday life setting of an insulin treated patient with diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Delivery Systems
- Trial name
- NCT00569426
- Testing
- NovoFine® needle 6 mm, NovoFine® needle 8 mm
- Where
- 10 sites in United Kingdom
- Volunteers
- 119 people
- Sponsor
- Novo Nordisk A/S
Type 2 Diabetes Mellitus
A Prospective Observational Study to Assess Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus
The purpose of the study is to obtain an assessment (efficacy, safety, and patient reported outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2 diabetes mellitus (T2DM).
- Trial name
- NCT02158078
- Testing
- PaQ® Insulin Delivery Device
- Where
- Austria
- Volunteers
- 8 people
- Sponsor
- CeQur Corporation
SGA, Turner Syndrome
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
The purpose of this study is to find out if somapacitan is safe and how well somapacitan works in children either born small for gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature.
- Conditions
- SGA, Turner Syndrome, Noonan Syndrome, ISS
- Trial name
- REAL 9 (NCT05723835)
- Testing
- Somapacitan
- Where
- 18 sites in United States, Malaysia and 4 more
- Volunteers
- 47 people
- Sponsor
- Novo Nordisk A/S
Metachromatic Leukodystrophy (MLD)
Multicenter Study of HGT-1110 Administered Intrathecally in Children With Metachromatic Leukodystrophy (MLD)
The purpose of this study is to determine the safety of ascending doses of HGT-1110 administered by intrathecal (IT) injection for 38 weeks (20 injections) in children with metachromatic leukodystrophy (MLD).
- Trial name
- IDEAMLD (NCT01510028)
- Testing
- Recombinant human arylsulfatase A
- Where
- 5 sites in Australia, Denmark and 3 more
- Volunteers
- 24 people
- Sponsor
- Shire
Type 2 Diabetes Treated With Insulin
A Randomized Trial Evaluating Control-IQ+ Technology in Adults With Type 2 Diabetes
A randomized controlled trial (RCT) to assess the safety and efficacy of use of Control-IQ+ technology in adults with type 2 diabetes using basal-bolus insulin therapy.
- Trial name
- 2IQP (NCT05785832)
- Testing
- t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM, Standard Therapy plus continuous glucose monitoring (CGM)
- Where
- 21 sites in United States, Canada
- Volunteers
- 319 people
- Sponsor
- Tandem Diabetes Care, Inc.
Mitral Valve Regurgitation
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
- Trial name
- TIARA-I (NCT02276547)
- Testing
- Mitral valve replacement
- Where
- 10 sites in United States, Belgium and 1 more
- Volunteers
- 27 people
- Sponsor
- Shockwave Medical, Inc.
Infection, Human Immunodeficiency Virus, HIV Infections
Incidence of Human Immunodeficiency Virus-1 (HIV-1) Infection in HIV-1 Uninfected High Risk Men Who Have Sex With Men
Studies to assess the effectiveness of interventions to prevent HIV infection depend upon robust estimates of Baseline HIV incidence rates.
- Trial name
- NCT03310515
- Testing
- Risk reduction counseling, Social harm interview, Computer-Assisted Self Interviewing technique
- Where
- 9 sites in China
- Volunteers
- 578 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Healthy
Study to Assess Adhesion Quality and Wear of Placebo JNJ-35685-AAA-G-023 Transdermal System in Healthy Adults
The purpose of this study is to assess 3 different scoring systems to evaluate the adhesive quality of placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial])…
- Trial name
- NCT02221726
- Testing
- JNJ-35684-AAA-023: Size 1; small patch, JNJ-35684-AAA-023: Size 2; large patch
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Critical Limb Ischemia (CLI)
Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System
This is a prospective, double-blinded, randomized, placebo-controlled, multi-center, pivotal clinical study in which subjects are evaluated for prevention of major limb amputation in the treatment of non-reconstructable…
- Trial name
- CLIRST III (NCT02538978)
- Testing
- Autologous Bone Marrow Concentrate (aBMC)
- Volunteers
- 224 people
- Sponsor
- Cesca Therapeutics, Inc.
Growth Hormone Deficiency
Easypod United States User Trial
This study will help to determine whether an injection log on a recombinant human growth hormone (rhGH) delivery device improves subjects' adherence with injection schedules.
- Trial name
- NCT00689260
- Testing
- easypod
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- EMD Serono
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone
This study is conducted in Europe. The purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Genetic Disorder, Turner Syndrome
- Trial name
- NCT01327924
- Testing
- Norditropin NordiFlex®
- Where
- France
- Volunteers
- 77 people
- Sponsor
- Novo Nordisk A/S
Limb-girdle Muscular Dystrophy
A Trial to Learn More About an Experimental Gene Therapy Called Bidridistrogene Xeboparvovec (SRP-9003) as a Possible Treatment for Limb Girdle Muscular Dystrophy 2E/R4
This is a multicenter, global study of the effects of a single systemic dose of SRP-9003 on beta-sarcoglycan (β-SG) gene expression in participants with limb-girdle muscular dystrophy, type 2E/R4 (LGMD2E/R4).
- Trial name
- EMERGENE (NCT06246513)
- Testing
- SRP-9003, Glucocorticoid
- Where
- 10 sites in United States, Belgium and 4 more
- Volunteers
- 17 people
- Sponsor
- Sarepta Therapeutics, Inc.
Wound of Skin, Ulcers
TrueLok Elevate PMCF Study
The TrueLok Elevate Transverse Bone Transport System is a modular external fixation device designed for transverse bone transport.
- Conditions
- Wound of Skin, Ulcers, Soft Tissue Defect
- Trial name
- NCT07079774
- Testing
- Transverse Bone Transport System
- Where
- 14 sites in Germany, Italy and 4 more
- Volunteers
- 153 people
- Sponsor
- Orthofix s.r.l.
Parkinson's Disease
Safety Study of Subthalamic Nucleus Gene Therapy for Parkinson's Disease
The purpose of this study is to determine the safety of using a modified virus to transfer a gene called GAD into a region of the brain called the subthalamic nucleus in patients with advanced Parkinson's disease.
- Trial name
- NCT00195143
- Testing
- Surgical infusion of AAV-GAD into the subthalamic nucleus
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neurologix, Inc.
Asthma
A Randomised, Double- Blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Tiotropium 5 µg Once Daily and Tiotropium 2.5 µg Twice Daily for Four Weeks in Patients With Moderate Persistent Asthma
Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for the compliance and convenience of the…
- Trial name
- NCT01152450
- Testing
- Tiotropium 2.5 µg b.i.d, Tiotropium 5 µg q.d.
- Where
- 15 sites in Austria, Czechia and 3 more
- Volunteers
- 94 people
- Sponsor
- Boehringer Ingelheim
Pain, Analgesia, Patient-Controlled
A Study to Compare Patient-controlled Pain Medications Delivered Either Through the Skin or Intravenously
The purpose of this study is to evaluate the effectiveness and safety of a patient-controlled system to deliver fentanyl compared with a patient-controlled intravenous system to deliver morphine in the management of postoperative…
- Conditions
- Pain, Analgesia, Patient-Controlled, Pain, Postoperative
- Trial name
- EuroTrans (NCT00996177)
- Testing
- IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem, IV Morphine Patient-Controlled Analgesia (IV PCA)
- Where
- 44 sites in Austria, Belgium and 8 more
- Volunteers
- 657 people
- Sponsor
- Janssen-Cilag International NV
Arthritis, Rheumatoid, Arthritis, Psoriatic
Study of Intra-articular Delivery of tgAAC94 in Inflammatory Arthritis Subjects
The 13G01 clinical trial is a Phase I/II dose escalation study designed to be conducted in adults with inflammatory arthritis who have persistent moderate or severe swelling in one or more joints, without a disease severe enough…
- Conditions
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Ankylosing Spondylitis
- Trial name
- NCT00126724
- Testing
- tgAAC94 gene therapy vector
- Where
- 22 sites in United States
- Volunteers
- 120 people
- Sponsor
- Targeted Genetics Corporation