Clinical trials: medical devices
Air Trapping, Emphysema
Xenon MRI to Evaluate Changes to Lung Function Following Bronchoscopic Treatment of Air Trapping in Emphysema
The objective of this study is to provide a regional, mechanistic characterization of pulmonary ventilation changes following treatment with the Apreo BREATHE System, using hyperpolarized ¹²⁹Xe MRI, in BREATHE-3 participants.
- Conditions
- Air Trapping, Emphysema, Hyperinflation
- Trial name
- BREATHE-Xe (NCT07896902)
- Testing
- Hyperpolarized Xenon MRI, Apreo BREATHE Airway Scaffold
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Apreo Health, Inc.
Epilepsy
Biomarker Targeted Stimulation for Epileptiform Events
This is a multicenter, prospective, controlled study designed to evaluate treatment with the BTS System.
- Trial name
- BTSEE (NCT06424977)
- Testing
- Biomarker Targeted Stimulation (BTS)
- Volunteers
- 40 people
- Sponsor
- Cadence Neuroscience
Sacroiliitis, Sacroiliac Joint Dysfunction
Post-Market Clinical Study on a Modular SI Joint Fusion System
A prospective study on the use of the TransLoc 3D SI Joint Fusion System for patients with sacroiliac joint disruptions or degenerative sacroiliitis.
- Trial name
- SPARTAN (NCT05916092)
- Testing
- TransLoc 3D
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- CornerLoc
Sleep Apnea - Obstructive
A Study of the Sleepnet Elara APAP Device
The goal of this study is to evaluate the effectiveness of the Elara APAP device.
- Trial name
- NCT07559708
- Testing
- Sleepnet Elara Treatment
- Where
- 2 sites in United States
- Volunteers
- 55 people
- Sponsor
- Sleepnet Corporation
Diabetes Mellitus
Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring
This study is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) will help prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1/GIP) agonists.
- Trial name
- NCT06668935
- Testing
- To utilize the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) to help prolong the length of time people with diabetes maintain adherence to GLP-1 and dual GIP/GLP-1 agonists
- Where
- 8 sites in United States
- Volunteers
- 800 people
- Sponsor
- Abbott Diabetes Care
Incontinence-associated Dermatitis, Decubitus Ulcer
Safety and Efficacy of RashEndZ Wound Aeration Technology
The aim of this study is to determine the safety and efficacy of RashEndZ therapeutic liner technology and Dynamic Oxygen Skin Therapy in improving symptoms and expediting healing of IAD and DU in adult patients.
- Trial name
- NCT07899060
- Testing
- Dynamic Oxygen Skin Therapy (DOST), Standard Wound Care
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- RashEndZ Inc.
Melanoma and Other Malignant Neoplasms of Skin, Basal Cell Carcinoma of Skin
TruScore Standalone Clinical Study
The goal of this clinical trial is to evaluate if the TruScore device can accurately diagnose suspicious skin lesions in patients aged 22 years and older.
- Conditions
- Melanoma and Other Malignant Neoplasms of Skin, Basal Cell Carcinoma of Skin, Squamous Cell Carcinoma of the Skin
- Trial name
- Standalone (NCT06793423)
- Testing
- Skin lesion diagnostic device evaluation
- Where
- 6 sites in United States
- Volunteers
- 464 people
- Sponsor
- VeriSkin, Inc.
Atrial Fibrillation
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
The main purpose of this clinical study is to investigate the effectiveness workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE™ Catheter and TRUPULSE™ Generator) when used for cardiac ablation with…
- Trial name
- VP-CONFIRM (NCT07429214)
- Testing
- Pulsed Field Ablation System
- Where
- 6 sites in Belgium, Denmark and 3 more
- Volunteers
- 42 people
- Sponsor
- Biosense Webster, Inc.
Bradycardia, Atrioventricular Block
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
The goal of this observational post-market clinical Follow-up study is to learn about the long-term safety, performance, and clinical benefits of pacing the left bundle branch area (LBBAP) using the INGEVITY+ pacemaker lead in…
- Conditions
- Bradycardia, Atrioventricular Block, Sinus Node Dysfunction, Bundle-Branch Block
- Trial name
- SEPTA PMCF (NCT07209852)
- Testing
- Pacemaker lead
- Where
- 13 sites in Belgium, France and 5 more
- Volunteers
- 140 people
- Sponsor
- Boston Scientific Corporation
Weight Loss
OverStitch NXT Endoscopic Suture System
To demonstrate the safety and efficacy of OverStitch NXT Endoscopic Suture System for endoscopic sleeve gastroplasty（ESG） in obese populations to support the registration of OverStitch NXT for ESG indication.
- Trial name
- NCT07276815
- Testing
- OverStitch NXT Endoscopic Suture System
- Where
- China
- Volunteers
- 136 people
- Sponsor
- Boston Scientific Corporation
Tibial Plateau Fracture
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
This study will compare two approaches to rehabilitation after surgery for a fracture of the upper part of the shinbone that involves the knee joint (tibial plateau fracture).
- Trial name
- NCT07897149
- Testing
- Crutch Tip Biofeedback System, Individualized FEA-Guided Postoperative Weight-Bearing, Usual-Care Postoperative Weight-Bearing
- Volunteers
- 86 people
- Sponsor
- Comeback Mobility Inc
Joint Replacement, Arthropathy
The restor3d Outcomes Registry
The restor3d Outcomes Registry is a prospective, longitudinal, decentralized study designed to capture patient-reported outcomes (PROs) from adults who have received an FDA-cleared or approved restor3d patient-specific orthopedic…
- Trial name
- NCT07563803
- Testing
- Patient-Specific Orthopedic Implant
- Where
- United States
- Volunteers
- 2,250 people
- Sponsor
- Restor3D
Weight Loss
Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365')
To demonstrate the safety and efficacy of Orbera365 in obese populations to support the registration of Orbera365.
- Trial name
- NCT07195708
- Testing
- Treatment group
- Where
- China
- Volunteers
- 144 people
- Sponsor
- Boston Scientific Corporation
Cardiovascular Diseases
A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China
A prospective, observational, single-arm, open-label, multicenter, post-approval study. To compile real-world clinical outcomes data for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System…
- Trial name
- NCT03736226
- Testing
- SYNERGYTM Stent System
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- Boston Scientific Corporation
Hyperglycemia, Diabetes
Insulin Balanced Infusion System
The purpose of this study is to study the use of a counterbalancing system of glucose and insulin infusion with frequent blood glucose monitoring and combined adaptive algorithm can produce tight glycemic control without…
- Trial name
- NCT01291719
- Testing
- glucose and insulin infusions
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Admetsys Corporation
Infertility, ART
Automation of the In Vitro Fertilization Laboratory
Enrolled patients will undergo an Assisted Reproductive technology (ART) treatment using intracytoplasmic sperm injection (ICSI, the direct injection of a single sperm cell into an oocyte) as the method of insemination.
- Trial name
- NCT06581068
- Testing
- AURA assisted ART treatment
- Where
- 2 sites in Mexico
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Conceivable Life Sciences
Multiple Sclerosis
Evaluating the Effects of the EXOPULSE Suit on Mobility, Walking Ability, and Balance in People With Multiple Sclerosis
This clinical research study is investigating whether the EXOPULSE Suit, a wearable device that delivers electrical stimulation, can help improve movement difficulties caused by spasticity in adults with multiple sclerosis (MS).
- Trial name
- EXO-MS (NCT07897760)
- Testing
- Electrostimulation suit
- Where
- 2 sites in United States, Germany
- Volunteers
- 100 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Nasal Obstruction Due to Inferior Turbinate Hypertrophy
Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
The study is a prospective, multi-center, post-market clinical study to evaluate the safety and effectiveness of REFLEX ULTRA 45 for the coblation inferior turbinate reduction in China.
- Trial name
- NCT07025304
- Testing
- REFLEX ULTRA 45
- Where
- 6 sites in China
- Volunteers
- 105 people
- Sponsor
- Smith & Nephew, Inc.
Chronic Pain
Focused Ultrasound Stimulation for the Treatment of Chronic Pain
ATTN201 is a non-invasive focused ultrasound neurostimulation device that delivers offline MRI-guided non-invasive focused ultrasound to target brain areas.
- Trial name
- ARPAIN (NCT07801443)
- Testing
- ATTN201 focused ultrasound system
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- Attune Neurosciences Inc
Heart Failure, Chronic Heart Failure
Voice-based Outcome Identification and Clinical Evaluation in Heart Failure
VOICE-HF is a clinical study designed to evaluate the performance of a novel non-invasive software device (Noah Labs Vox) that uses vocal characteristics to estimate DHF risk and has strong potential for clinical success.
- Conditions
- Heart Failure, Chronic Heart Failure, Chronic Heart Disease
- Trial name
- VOICE-HF (NCT07870395)
- Testing
- Daily Voice Recording
- Where
- United States
- Volunteers
- 450 people
- Sponsor
- Noah Labs