Clinical trials: Feasibility Studies
Benign Prostatic Hyperplasia, Adenoma, Prostatic
Rezum FIM Optimization Study
Evaluate the effect of the NxThera BPH Rezum System on prostate tissue in subjects suffering from LUTS symptoms secondary to benign prostatic hyperplasia (BPH).
- Conditions
- Benign Prostatic Hyperplasia, Adenoma, Prostatic, Prostatic Adenoma, Prostatic Hyperplasia, Benign
- Trial name
- Rezum FIM (NCT02940392)
- Testing
- Rezum System
- Where
- Dominican Republic
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Blood Loss, Surgical, Postoperative Hemorrhage
Study of the Hemorai Vysio Wearable Device for Monitoring Changes Related to Blood Loss in Patients During and After Surgery.
The goal of this clinical trial is to learn whether the Hemorai Vysio wearable device can be used safely and feasibly to track relative changes over time in tissue oxygen, hemoglobin-related signals, blood flow, and oxygen use…
- Trial name
- VYSIO-FEASIBIL (NCT07826637)
- Testing
- Wearable optical hemodynamic monitoring device
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Hemorai Inc
Heart Failure With Preserved Ejection Fraction
The PeriCut Catheter System Early Feasibility Study (REIMAGINE-HFpEF)
The PeriCut early feasibility study will evaluate the safety and feasibility of successfully performing a minimally invasive pericardiotomy in patients with heart failure with preserved ejection fraction using the PeriCut…
- Trial name
- REIMAGINE-HF (NCT06702501)
- Testing
- PeriCut Catheter System performs minimally invasive pericardiotomy
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Heart Failure Solutions, Inc.
Hepatic Failure
Liver Function Assessment - Feasibility and Dosing Study
The purpose of this study is to 1) determine the feasibility of using Cardiox Liver Function Assessment System (LFA) to measure indocyanine green (ICG) clearance; 2) determine an adequate dose based on LFA technology and 3)…
- Trial name
- NCT02516319
- Testing
- ICG Dye
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Cardiox Corporation
Upper Gastrointestinal Laparoscopic Surgery
A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgical System for Use in Laparoscopic Upper Gastrointestinal Surgeries.
A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgical System for Use in Laparoscopic Upper Gastrointestinal Surgeries.
- Trial name
- NCT07293611
- Testing
- Levita Magnetic Surgical System
- Where
- 2 sites in Chile
- Volunteers
- 30 people
- Sponsor
- Levita Magnetics
Breast Cancer
Feasibility Study of Meso BioMatrix Device for Breast Reconstruction
The purpose of the study is to evaluate the safety and feasibility of the use of Meso BioMatrix Acellular Peritoneum Matrix for the reinforcement of weakened soft tissue during 2-stage, tissue expander assisted breast…
- Trial name
- NCT01823107
- Testing
- Meso BioMatrix Device
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- Kensey Nash Corporation
Anemia, Sickle Cell
CSL200 Gene Therapy in Adults With Severe Sickle Cell Disease
This is a phase 1 pilot study of CSL200 in adult subjects with severe sickle cell disease. The primary objectives of this study are to evaluate the safety of the following: collection of CD34+ hematopoietic stem / progenitor…
- Trial name
- NCT04091737
- Testing
- Autologous enriched CD34+ cell fraction that contains CD34+ cells transduced with lentiviral vector encoding human γ-globinG16D and short-hairpin RNA734
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- CSL Behring
Pregnancy Related, Cesarean Wound Disruption
The Collection and Application of Autologous Amniotic Fluid At Cesarean Delivery Closure.
The purpose of this study is to determine the feasibility of collecting amniotic fluid at delivery that will be immediately processed and then applied as a spray to the various layers of cesarean wound closure.
- Conditions
- Pregnancy Related, Cesarean Wound Disruption, Cesarean Section; Infection
- Trial name
- NCT04359472
- Testing
- Application of Autologous Amniotic Fluid
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Recibio, Inc.
Nervous System Disorder
Use of Betashot in Children and Adults With Epilepsy
In brief, this research is a prospective, feasibility study to evaluate the use of Betashot- a medium chain triglyceride- based (MCT) food for special medical purposes (FSMP) in children and adults diagnosed with epilepsy.
- Trial name
- NCT02825745
- Testing
- Betashot
- Where
- 2 sites in United Kingdom
- Volunteers
- 77 people
- Sponsor
- Vitaflo International, Ltd
Alzheimer Disease, Mild Cognitive Impairment (MCI)
Yoga-based, Movement Therapy Device as Noninvasive Glymphatic Clearance Augmentation in Alzheimer's Disease.
This clinical trial evaluates a yoga-based intervention delivered through a powered therapeutic device designed to guide breathing and body movements.
- Trial name
- ReGlyde (NCT06989242)
- Testing
- Yoga-Based Therapeutic Device (incorporating guided breathing and movement)
- Where
- 3 sites in Czechia, Slovakia
- Volunteers
- 60 people
- Sponsor
- CIATRIX, INC.
Uncontrolled Hypertension
Multi-electrode Radiofrequency Renal Denervation System Feasibility Study
This is a prospective, single-arm, non-randomized and open label feasibility study. The study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal denervation in patients with uncontrolled…
- Trial name
- NCT01699529
- Testing
- Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 50 people
- Sponsor
- Medtronic Vascular
Metastatic Breast Cancer in the Spine
ZETAMET™ BONE GRAFT IN THE REPAIR OF BONE DEFECTS FROM METASTATIC BREAST CANCER IN VERTEBRAL BONES
ZetaMet™ is indicated for patients with destructive, lytic lesions due to metastatic breast cancer to bone, with or without involvement of other sites, with at least one metastatic lesion located in a vertebral body of the spine…
- Trial name
- ZGMBC (NCT05280067)
- Testing
- ZetaMet™ (ZetaFuse™ Bone Graft)
- Where
- 2 sites in Canada
- Volunteers
- 10 people
- Sponsor
- Zetagen Therapeutics, Inc
Cataract Surgery
Pilot Study: Feasibility and Usability of a Head-Mounted Spatial Computing Device for Intraoperative Visualization During Intraocular Surgery
To evaluate the feasibility and usability of Apple Vision Pro as an adjunct visualization and information display tool during ophthalmic surgery.
- Trial name
- NCT07825337
- Testing
- Apple Vision Pro Visualization System
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Eric Rosenberg
Prostate Cancer
Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery
The study involves use of a device called an endomicroscope to obtain high resolution images of microscopic structures during robot-assisted prostate cancer surgery.
- Trial name
- NCT00792961
- Testing
- Endomicroscopy
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Peter Delaney
Mitral Valve Disease, Mitral Valve Stenosis
Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement
The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Mitral Valve to collect evidence on the device's safety and performance.
- Conditions
- Mitral Valve Disease, Mitral Valve Stenosis, Mitral Valve Failure
- Trial name
- FOLDAX (NCT04717570)
- Testing
- Foldax TRIA Mitral Valve
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Foldax, Inc
Tetraplegia/Tetraparesis, Quadriplegia
VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration
The VOICE Study is an early feasibility study to evaluate the initial clinical safety and efficacy of the N1 and R1 Systems device design concept in providing an ability to communicate.
- Conditions
- Tetraplegia/Tetraparesis, Quadriplegia, Cervical Spinal Cord Injury, Amyotrophic Lateral Sclerosis
- Trial name
- NCT07224256
- Testing
- N1 Implant, R1 Robot
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Neuralink Corp
Tooth Extraction Site Healing, Ridge Augmentation
Safety and Performance, and Dose, of OsteoAdapt DE in Localized Alveolar Ridge Augmentations
This study's objective is to evaluate OsteoAdapt DE's safety and performance in comparison to Xenograft particulate bone graft for alveolar ridge augmentation.
- Conditions
- Tooth Extraction Site Healing, Ridge Augmentation, Bone Graft
- Trial name
- RESTORE (NCT07078331)
- Testing
- OsteoAdapt DE (0.8 mg), OsteoAdapt DE (2.0 mg), Xenograft Bone Graft
- Where
- 6 sites in Armenia, Israel
- Volunteers
- 45 people
- Sponsor
- Theradaptive, Inc
Mental Wellbeing
A 12-week Feasibility Trial of a Mental Health Breakfast Show Wakey
The aim of Wakey! is to increase access to wellbeing support to lower socio-economic groups who have traditionally been excluded from the design and evaluation of digital mental health interventions.
- Trial name
- NCT04287296
- Testing
- Wakey!
- Where
- United Kingdom
- Volunteers
- 3,993 people, healthy volunteers welcome
- Sponsor
- Method X Studios Ltd
Noninvasive Ventilation, Respiratory Insufficiency
A Feasibility Study Evaluating the Use of a Non-invasive Ventilation Mask
Evaluate the clinicians assessment of the use of an oro-nasal mask during non-invasive ventilation (non-intubated) with a feasibility study.
- Trial name
- mask (NCT02383719)
- Testing
- Oro-nasal Mask
- Volunteers
- 18 people
- Sponsor
- Convergent Engineering, Inc.
Anxiety Disorders
Pre-Post Intervention Study to Investigate the Safety, Feasibility, & Efficacy of the NeurGear ZenBud System for the Treatment of Anxiety & Anxiety-Related Symptoms
The goal of this clinical trial is to learn if low intensity fodused ultrasound stiulation delivered to the auricular branch of the vagus nerve works to mitigate symptoms of anxiety disorder in adults.
- Trial name
- NCT06574971
- Testing
- Low intensity focused ultrasound using the NeurGear Zenbud
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- NeurGear