Clinical trials: Implant Placement
Hearing Loss
Littlears Auditory Questionnaire: Validation Study in CI Children
The LittlEARS Auditory Questionnaire is designed to assess the development of the auditory behavior in children during the first two (hearing) years.
- Trial name
- LittlEars (NCT00785707)
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- Med-El Corporation
Aortic Stenosis
PARTNER II Trial: S3iCAP
Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk.
- Trial name
- PII S3i CAP (NCT02687035)
- Testing
- SAPIEN S3 valve
- Where
- 56 sites in United States, Canada
- Volunteers
- 1,822 people
- Sponsor
- Edwards Lifesciences
Postpartum
Home-based Delivery of the Contraceptive Implant in Postpartum Guatemalan Women
Abstract Background: Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth.
- Trial name
- NCT04005391
- Testing
- Offer of Participant's Choice of Contraception Method
- Where
- 2 sites in United States, Guatemala
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Postpartum Contraception, Family Planning
Labor and Delivery Implant Insertion: A Randomized Controlled Trial
A barrier to initiating progestin contraceptives in the early postpartum period is the concern of interference with breastfeeding, specifically lactogenesis.
- Trial name
- LADII (NCT02866643)
- Testing
- Etonogestrel-Immediate, Etonogestrel-Delayed
- Where
- United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Stanford University
MPS I
Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-318 in Subjects With MPS I
The purpose of the study is to evaluate the safety, tolerability of ascending doses of SB-318. SB-318 is an intravenously delivered Zinc Finger Nuclease (ZFN) Therapeutic for genome editing.
- Trial name
- NCT02702115
- Testing
- SB-318
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Sangamo Therapeutics
Sensorineural Hearing Loss, Bilateral, Cochlear Implant
Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.
- Trial name
- NCT03304106
- Testing
- Commercially available cochlear implant and AI system
- Where
- 9 sites in United States
- Volunteers
- 102 people
- Sponsor
- Cochlear
Mucopolysaccharidosis II, MPS II
Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-913 in Subjects With MPS II
The purpose of the study is to evaluate the safety, tolerability and effect on leukocyte and plasma Iduronate 2-Sulfatase (IDS) enzyme activity of ascending doses of SB-913.
- Trial name
- NCT03041324
- Testing
- SB-913
- Where
- 5 sites in United States
- Volunteers
- 9 people
- Sponsor
- Sangamo Therapeutics
Pain
Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women
This study is designed to evaluate if self-inserted intravaginal 2% lidocaine gel is effective at decreasing pain during intrauterine device insertion in nulliparous women.
- Trial name
- LIVIIN (NCT01534520)
- Testing
- Lidocaine
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Hearing Loss
N6 Input Processing in Traditional CI Recipients
The purpose of this study is to evaluate the enhanced signal processing features of the Nucleus 6 Sound Processor on existing Nucleus cochlear implant recipients currently using the Nucleus 5 Sound Processor.
- Trial name
- NCT02239263
- Testing
- Nucleus 6 Sound Processor
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Cochlear
Adolescent Well-Being, Mental Health Wellness
Predict the Best Level of Care Placement for Each Child's Behavioral Health Needs - Effectiveness Study
The purpose of this study is to test the effectiveness of a new clinical decision support tool, Placement Success Predictor (PSP), in a naturalistic setting.
- Trial name
- NCT06834763
- Testing
- Clinical team access to Placement Success Predictor (PSP) results
- Where
- United States
- Volunteers
- 403 people
- Sponsor
- Outcome Referrals, Inc.
Contraception
Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement
This is randomized controlled trial designed for pregnant women who deliver vaginally at the University of Louisville Hospital and desire to have an intrauterine device (IUD) inserted for postpartum contraception.
- Trial name
- IUD (NCT01598662)
- Testing
- Mirena (levonorgestrel-releasing intrauterine system)
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of Louisville
Time, Patient Preference
DryShield vs Cotton Roll Isolation During Sealants Placement: Efficiency and Patient Preference
The goals of this study are to determine if 1) placement times of pit and fissure sealants using the DryShield system differ from those when using the cotton roll isolation technique; and 2) there is a significant difference in…
- Trial name
- NCT02995369
- Testing
- DryShield, Cotton rolls
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Montefiore Medical Center
Child Behavior
Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P)
Randomized Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P). The goal of the proposed study is to conduct a randomized clinical trial of a new, low-cost, manualized, group-based intervention for…
- Trial name
- KEEP-P (NCT03106636)
- Testing
- KEEP-P, KEEP-P+
- Where
- United States
- Volunteers
- 442 people, healthy volunteers welcome
- Sponsor
- University of Oregon
Malocclusion, Class II Buccal Segment Relationship
Chesterfield Micro-implant Study Involving Three Types of Anchorage Methods in Orthodontics
Research problem: Anchorage reinforcement is effective with headgear provided patient compliance is optimal. Nance palatal arch have also been shown to be effective.
- Trial name
- PJSPhD (NCT00995436)
- Testing
- Extraoral anchorage, Miniscrews, Nance
- Where
- United Kingdom
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Chesterfield and North Derbyshire Royal Hospital
Bleeding, Implants
Use of Curcumin to Treat Unfavorable Bleeding Patterns in Contraceptive Implant Users
The investigators plan to study the effects of curcumin, the active ingredient in the spice turmeric, on the irregular bleeding experienced by women who use the contraceptive implant.
- Conditions
- Bleeding, Implants, Breakthrough Bleeding
- Trial name
- NCT04205929
- Testing
- Curcumin
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University
Intrauterine Devices
Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs
Study to analyze electronic medical records of women using an intrauterine device (IUD). The study was required by the FDA for the marketed IUD Mirena (US Post-marketing requirement; short name of study: APEX IUD).
- Trial name
- APEX IUD (NCT03754556)
- Testing
- Intrauterine device
- Where
- 4 sites in United States
- Volunteers
- 326,658 people, healthy volunteers welcome
- Sponsor
- Bayer
Postpartum Period
Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial
In order to determine the timing of LNG-IUS insertion that results in a greater proportion of women using the LNG-IUS at 6-months post-partum, we will perform a randomized control trial of interval versus immediate post-placenta…
- Trial name
- MISTIC (NCT01272960)
- Testing
- Post-Placenta Mirena Insertion, Interval Insertion
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Otitis Media
Singapore Tympanostomy Tube Delivery System Study
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes (TTs) in patients indicated for such treatment for chronic otitis…
- Trial name
- NCT01046877
- Testing
- Tympanostomy Tube Delivery System
- Where
- Singapore
- Volunteers
- 25 people
- Sponsor
- Integra LifeSciences Corporation
Otitis Media With Effusion
OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
- Trial name
- NCT01949155
- Testing
- OTO-201
- Where
- United States
- Volunteers
- 266 people
- Sponsor
- Otonomy, Inc.
Central Precocious Puberty
Histrelin Subcutaneous Implant in Children With Central Precocious Puberty
The purpose of this study is to follow and collect additional medical and developmental information on children after histrelin subcutaneous implant therapy is discontinued.
- Trial name
- NCT00779103
- Testing
- Histrelin Subcutaneous Implant
- Volunteers
- 36 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company