Clinical trials: Implant Therapy
Type 1 Diabetes
Medtronic MiniMed Implantable Insulin Pump
This research is being done to find out whether subjects previously treated with the implantable insulin pump (IIP) therapy, and now taking insulin by injection, will benefit from re-implantation of IIP.
- Trial name
- NCT00298740
- Testing
- Aventis U-400 Insulin
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Johns Hopkins 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
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
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
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
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
Bleeding, Implants
Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users
The etonogestrel (ENG) subdermal contraceptive implant (ENG implant) is a highly effective method of preventing pregnancy, but it has bleeding side effects that make it unappealing for many women.
- Conditions
- Bleeding, Implants, Breakthrough Bleeding
- Trial name
- Tamoxifen/BTB (NCT02903121)
- Testing
- Tamoxifen, Tamoxifen (open label)
- Where
- United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University
Otitis Media
Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion
This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS).
- Trial name
- inVENT2 (NCT02150044)
- Testing
- Acclarent Tympanostomy Tube Delivery System (TTDS).
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Integra LifeSciences Corporation
Transcatheter Aortic Valve Implantation
Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement
Implementation of Physical Therapy (PT) and Occupational Therapy (OT) pathway (initiation of services on Post procedure day #1 and continued daily with focus on education and activity progression) for all patients undergoing a…
- Trial name
- PTOTtAVR (NCT03117296)
- Testing
- Post procedure daily PT and OT, PT post procedure, OT post procedure
- Where
- United States
- Volunteers
- 189 people
- Sponsor
- Henry Ford Health System
Otitis Media With Effusion
Clinical Study of the Tympanostomy Tube Delivery System
The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube [TT(s)] in patients indicated for such…
- Trial name
- inVENT (NCT00939796)
- Testing
- Acclarent Tympanostomy Tube Delivery System
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Integra LifeSciences Corporation
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients…
- Trial name
- SURTAVI (NCT01586910)
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 86 sites in United States, Canada and 7 more
- Volunteers
- 1,746 people
- Sponsor
- Medtronic Cardiovascular
Menstruation Disturbances
Tamoxifen for the Treatment of Unfavorable Bleeding in Contraceptive Implant Users
The purpose of this study is to study whether a drug called tamoxifen can reduce vaginal bleeding in women who are using the Etonogestrel contraceptive implant.
- Trial name
- NCT02070692
- Testing
- Tamoxifen
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Oregon Health and Science University
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic…
- Trial name
- PII A (NCT01314313)
- Testing
- TAVR Implantation with SAPIEN XT, SAVR Implantation
- Where
- 57 sites in United States, Canada
- Volunteers
- 2,032 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
PREVAIL-J - Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan)
A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, Ascendra2™ transapical delivery…
- Trial name
- NCT01113983
- Testing
- Transcatheter aortic valve implantation
- Where
- 3 sites in Japan
- Volunteers
- 64 people
- Sponsor
- Edwards Lifesciences
Dental Polymer Based Filling Material
Bisphenol A in Saliva and Urine Related to Placement of Dental Composites
It has been reported that therapy with polymer-based dental filling materials was associated with higher concentrations of bisphenol A in saliva and urine directly after the treatment.
- Trial name
- NCT02575118
- Testing
- Restoration of dental caries with dental composite
- Where
- Norway
- Volunteers
- 20 people
- Sponsor
- NORCE Norwegian Research Centre AS
Otitis Media With Effusion in Children, Otitis Media Recurrent
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2
The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).
- Trial name
- NCT02436304
- Testing
- EXE844 Sterile Otic Suspension, 0.3%, Tympanostomy Tube Insertion
- Volunteers
- 404 people
- Sponsor
- Alcon Research
Otitis Media With Effusion in Children, Otitis Media Recurrent
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT)
The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).
- Trial name
- NCT02432105
- Testing
- EXE844 Sterile Otic Suspension, 0.3%, Tympanostomy Tube Insertion
- Volunteers
- 470 people
- Sponsor
- Alcon Research
Contraception
Nitrous Oxide for Pain Management of Intrauterine Device (IUD) Insertion
The purpose of this study is to determine whether Nitrous Oxide is effective in achieving pain control and satisfaction among nulliparous women getting the intrauterine device (IUD).
- Trial name
- NIUD (NCT02391714)
- Testing
- IUD insertion, Povidone-Iodine, Chlorhexidine
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of New Mexico