Clinical trials: medical devices
Prostate Cancer
Rectal Spacer for Prostate Cancer Radiation Image Guidance
The purpose of the study is to determine if a radiopaque hydrogel rectal spacer, SpaceOAR Vue®, can be used in place of fiducial markers when aligning patients for radiotherapy.
- Trial name
- NCT05650021
- Testing
- SpaceOAR Vue
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Milton S. Hershey Medical Center
Atypical Endometrial Hyperplasia, Stage I Uterine Corpus Cancer AJCC v7
Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
This phase II trial studies how well levonorgestrel-releasing intrauterine system works in treating patients with complex atypical hyperplasia or grade I endometrial cancer.
- Conditions
- Atypical Endometrial Hyperplasia, Stage I Uterine Corpus Cancer AJCC v7, Stage IA Uterine Corpus Cancer AJCC v7, Stage IB Uterine Corpus Cancer AJCC v7
- Trial name
- NCT00788671
- Testing
- Laboratory Biomarker Analysis, Levonorgestrel-Releasing Intrauterine System, Quality-of-Life Assessment
- Where
- 7 sites in United States
- Volunteers
- 69 people
- Sponsor
- M.D. Anderson Cancer Center
Tricuspid Valve Regurgitation, Heart Valve Diseases
TRISCEND JAPAN Study
A prospective, open, non-randomized, multicenter, clinical trial to evaluate the safety and effectiveness of the Edwards EWJ-202 transcatheter tricuspid valve replacement system in the treatment of patients with at least severe…
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- TRISCEND JAPAN (NCT05760989)
- Testing
- Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System
- Where
- 8 sites in Japan
- Volunteers
- 53 people
- Sponsor
- Edwards Lifesciences
Postoperative Pain, Total Shoulder Arthroplasty
Cohort 1 (TSA) of: A Multi-surgery Assessment of ZYNRELEF (HTX-011)
Cohort 1 (subjects undergoing total shoulder arthroplasty, TSA) of a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing different surgical…
- Conditions
- Postoperative Pain, Total Shoulder Arthroplasty, Multimodal Analgesia
- Trial name
- AMAZE (NCT06109415)
- Testing
- HTX-011, Bupivacaine Hydrochloride, MMA regimen
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Heron Therapeutics
Colon Cancer, Colon Polyp
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
For patients with colon polyps (clumps of cells in the lining of the colon) treatment often requires removal of the affected portion of the colon.
- Conditions
- Colon Cancer, Colon Polyp, Diverticular Diseases, Inflammatory Bowel Diseases
- Trial name
- NCT04703829
- Testing
- VI-RASD use in minimally invasive right or left colectomy, Right or Left colectomy
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Virtual Incision Corporation
Working Memory
Non-Invasive Brain Stimulation to Control Large-Scale Brain Networks
This project will assess the feasibility of traveling wave transcranial alternating current stimulation (tACS) to modify working memory performance and large-scale brain connectivity in surgical epilepsy patients.
- Trial name
- NCT04680481
- Testing
- Transcranial alternating current stimulation
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Minnesota
Back Pain, Insomnia
Trial on the Effect of Optically Modified Fiber Mattress Covers on Sleep Disturbances in Patients With Chronic Back Pain
Sleep quantity and quality can be influenced by the type of mattress used. This study is being done to see if a mattress cover with optically active particles can help back pain and improve sleep quality.
- Trial name
- NCT00969540
- Testing
- Active Mattress Cover
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of California, Irvine
Stroke
Premotor Cortex: A New Target for Stroke Motor Rehabilitation
The goal of the study is to determine the effect of repetitive transcranial magnetic stimulation (rTMS) over the premotor cortex on training-related improvements in motor performance and associated neural plasticity.
- Trial name
- NCT02565199
- Testing
- rTMS Over Contralateral Hemisphere of Premotor Cortex, rTMS Over Ipsilateral Hemisphere of Premotor Cortex, Control 1: rTMS Timed 400 ms After Movement-related EMG
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Emory University
Mild Cognitive Impairment
Network-guided TMS in Early Alzheimer's Disease
The proposed research will test a novel network-based neurostimulation approach using MRI-derived measures of brain connectivity to establish target sites for neurostimulation and test for the enhancement of memory function…
- Trial name
- NetTMS (NCT04549155)
- Testing
- Transcranial Magnetic Stimulation
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Duke University
Stem Cell Transplant, Adherence, Medication
BMT4me: Post-HSCT Medication Adherence mHealth App
This is a mixed methods, prospective longitudinal pilot RCT to evaluate the 1) acceptability of a newly developed mHealth app (BMT4me), 2) the feasibility of enrolling and retaining caregivers of children in the acute phase…
- Conditions
- Stem Cell Transplant, Adherence, Medication, Digital Health
- Trial name
- Bmt4me 2 (NCT05515497)
- Testing
- BMT4me 2.0 app
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Micah Skeens
Pain, Chronic, Failed Back Surgery Syndrome
Burst Spinal Cord Stimulation (Burst-SCS) Study
Recently a new form of spinal cord stimulation therapy called burst spinal cord stimulation (Burst-SCS) is available to treat chronic pain. The goal of this study is to learn more about how Burst-SCS works to reduce chronic pain.
- Trial name
- NCT03718325
- Testing
- Burst-SCS
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Michigan
Postoperative Pain
PK and Safety After C-Section
The main goal of the study was to measure the amount of the active ingredients and other components of HTX-011 in plasma and expressed breast milk over time following postpartum administration in women undergoing a planned…
- Trial name
- NCT03955211
- Testing
- HTX-011, ZYNRELEF kit components for administration, MMA regimen
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Heron Therapeutics
Hemorrhage, Surgical, Blood Loss, Surgical
Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)
Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-Antithrombotic Removal (ATR) system for intraoperative removal of ticagrelor in patients undergoing urgent…
- Conditions
- Hemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative, Hemorrhage Postoperative
- Trial name
- STAR-T (NCT04976530)
- Testing
- DrugSorb-ATR system
- Where
- 29 sites in United States, Canada
- Volunteers
- 140 people
- Sponsor
- CytoSorbents, Inc
Colorectal Cancer, Polyp of Colon
EAGLE Trial CADDIE Artificial Intelligence Endoscopy
The EAGLE study is a prospective randomized controlled multicenter parallel design trial, for the assessment of clinical performance of the CADDIE device and to confirm that the device performs as expected.
- Conditions
- Colorectal Cancer, Polyp of Colon, Adenoma Colon
- Trial name
- EAGLE (NCT05730192)
- Testing
- Colonoscopy with CADDIE, Standard Colonoscopy
- Where
- 8 sites in Germany, Italy and 2 more
- Volunteers
- 985 people
- Sponsor
- Odin Medical
Glioblastoma
Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma
This is a single institution, open-label, single arm, study assessing the safety, feasibility, and immunogenicity of a personalized neoantigen-based vaccine in subjects with newly diagnosed, unmethylated glioblastoma.
- Trial name
- NCT04015700
- Testing
- Personalized neoantigen DNA vaccine supplied by Geneos Therapeutics, CELLECTRA®2000 EP Device supplied by Geneos Therapeutics, Plasmid encoded IL-12
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Washington University School of Medicine
Advanced Cancer, Pancreatic Cancer Metastatic
Safety Study of Whole Body Hyperthermia for Advanced Cancer
Millions of patients die of cancer every year. There are several methods to treat cancer, including surgery, chemotherapy, radiotherapy and immunotherapy. Recently, hyperthermia therapy started playing a role in cancer therapy.
- Trial name
- MATTERS (NCT04467593)
- Testing
- Whole body hyperthermia, Standard of Care (SOC) chemotherapy according to the NCCN guidelines.
- Where
- Belgium
- Volunteers
- 16 people
- Sponsor
- ElmediX
Magnetic Resonance Imaging
Clinical Use of a New Neonatal MRI System
The purpose of the present study is to make medically indicated state of the art/high end magnetic resonance imaging (MRI) exams available to all infants in the Cincinnati Children's Hospital Medical Center (CCHMC) Neonatal…
- Trial name
- NCT01801865
- Testing
- GE OPTIMA MR430s with HDX/GE Electronics
- Where
- United States
- Volunteers
- 657 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Perception of Pain, Protection of the Palate
Flowable Resin Versus Self-Adhesive Dressing for Palatal Donor-Site Protection
This pilot randomized clinical study compared two methods for protecting the palatal donor site after harvesting a free gingival graft.
- Trial name
- NCT06593275
- Testing
- Flowable Resin Composite Palatal Barrier, Self-Adhesive Oral Dressing
- Where
- Ecuador
- Volunteers
- 12 people
- Sponsor
- Universidad de Especialidades Espiritu Santo
Femoral Arteriotomy Closure
Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes
This is an observational study designed to evaluate the safety and clinical outcomes of the MANTA® Vascular Closure Device (VCD) (the MANTA® Device) in TAVR procedures.
- Trial name
- ACCESS MANTA (NCT05936996)
- Testing
- MANTA Vascular Closure Device
- Where
- 10 sites in United States, Canada
- Volunteers
- 258 people
- Sponsor
- Essential Medical, Inc.
Spinal Duraplasty
Adherus™ Dural Sealant in Spinal Procedures
The purpose of this study is to test an experimental device, the Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant, in spinal surgical procedures.
- Trial name
- NCT04498026
- Testing
- Adherus Dural Sealant System, DuraSeal Exact Dural Sealant System
- Where
- 14 sites in United States
- Volunteers
- 94 people
- Sponsor
- Stryker Craniomaxillofacial
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