Clinical trials: sponsored by Massachusetts General Hospital
Carotid Artery Calcification, Carotid Artery Diseases
Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid IDE [Investigational Device Exemption] Study)
Prospective, Multi-center, Single-arm Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid…
- Trial name
- NCT07062471
- Testing
- Carotid Intravascular Lithotripsy (IVL)
- Where
- 25 sites in United States
- Volunteers
- 185 people
- Sponsor
- Shockwave Medical, Inc.
Progressive Supranuclear Palsy(PSP), Dementia With Lewy Bodies (DLB)
Digital Health Technologies for Progressive Supranuclear Palsy and Dementia With Lewy Bodies
Progressive supranuclear palsy (PSP), mild cognitive impairment with Lewy bodies (MCI-LB), and Dementia with Lewy Bodies (DLB) are severe neurodegenerative diseases that cause significant motor impairment impacting daily…
- Conditions
- Progressive Supranuclear Palsy(PSP), Dementia With Lewy Bodies (DLB), PSP, Lewy Body Dementia (LBD)
- Trial name
- NCT07240805
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- BioSensics
Solid Tumor, Unspecified, Adult, Lymphoma
Granzyme B PET Imaging Drug as a Predictor of Immunotherapy Response to Checkpoint Inhibitors
First in Human Safety of [68Ga]-NOTA-hGZP PET Imaging in subjects with cancer undergoing treatment with a checkpoint inhibitor either as a monotherapy of in combination I-O therapy
- Trial name
- NCT04169321
- Testing
- Single Arm
- Where
- 3 sites in United States, Taiwan
- Volunteers
- 13 people
- Sponsor
- Cytosite Biopharma Inc.
Myasthenia Gravis Generalized
Quantification of Change in MG Disease Activity in Individuals With Generalized Myasthenia Gravis (gMG) After Administration of VYVGART® or VYVGART Hytrulo® Using BioDigit MG
Evaluate the feasibility of using digital health technologies to monitor disease symptoms over time in individuals with gMG who are initiating treatment with VYVGART® or VYVGART Hytrulo®.
- Trial name
- BioDigit MG-03 (NCT07226830)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- BioSensics
Frontotemporal Lobar Degeneration (FTLD), Frontotemporal Dementia (FTD)
A Wearable Sensor Platform for Remote Monitoring of Individuals on the Frontotemporal Dementia Spectrum
The primary objective of this clinical study is to provide the initial validation for monitoring biomarkers of symptoms and functioning for individuals with frontotemporal lobar degeneration (FTLD) syndromes.
- Conditions
- Frontotemporal Lobar Degeneration (FTLD), Frontotemporal Dementia (FTD), Corticobasal Degeneration, Corticobasal Syndrome (CBS)
- Trial name
- ReMoTe (NCT07569367)
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- BioSensics
Amyotrophic Lateral Sclerosis
RAPA-501 Therapy for ALS
RAPA-501-ALS is a phase 2/3 expansion cohort study of RAPA-501 autologous hybrid TREG/Th2 cells in patients living with amyotrophic lateral sclerosis (pwALS).
- Trial name
- NCT04220190
- Testing
- RAPA-501 Autologous T stem cells
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Rapa Therapeutics LLC
Parkinson Disease
Low-dose Carbon Monoxide (HBI-002) Trial to Evaluate Safety, Tolerability, PK, and Biomarkers in Parkinson's Disease
A phase 2a multicenter, randomized, double-blind, placebo-controlled multiple dose study to evaluate the safety, tolerability, pharmacokinetics, of HBI-002, an oral low-dose carbon monoxide (CO) liquid drug product, administered…
- Trial name
- LoCaMoTE-PD (NCT07005180)
- Testing
- HBI-002
- Where
- 8 sites in United States
- Volunteers
- 36 people
- Sponsor
- Hillhurst Biopharmaceuticals, Inc.
Carotid Artery Calcification, Carotid Artery Diseases
Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral Stenting (SKYWARD Trans-Femoral IDE [Investigational Device Exemption] Study)
Prospective, Multi-center, Single-arm Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral stenting (SKYWARD Trans-Femoral…
- Trial name
- SKYWARD TF (NCT07512128)
- Testing
- Carotid Intravascular Lithotripsy
- Where
- 25 sites in United States
- Volunteers
- 185 people
- Sponsor
- Shockwave Medical, Inc.
Pharmacokinetics, Neurology
A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Healthy Adult Subjects
The goal of this clinical trial is to assess the safety and effects of a crystalized form of lithium, AL001, when compared to commonly used Lithium Carbonate in healthy volunteers.
- Trial name
- NCT06921590
- Testing
- AL001, Lithium Carbonate Capsule
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Alzamend Neuro, Inc.
Bipolar I Disorder
A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I Disorder
The goal of this clinical trial is to assess the safety and effects of a crystallized form of lithium, AL001, when compared to commonly used lithium carbonate in individuals diagnosed with bipolar I disorder.
- Trial name
- NCT07540338
- Testing
- AL001, Lithium carbonate
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Alzamend Neuro, Inc.
Opiate-Related Disorders, Opiate Substitution Treatment
A Chatbot To Support Substance Use Recovery
The goal of this clinical trial is to learn if/how an AI chatbot can support patients who in recovery for substance use, specifically those who are receiving medication for opioid use disorder.
- Trial name
- NCT06845878
- Testing
- chatbot
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Dimagi Inc.
Hypertension Resistant to Conventional Therapy, Bradycardia
Moderato System: A Double-Blind Randomized Trial Ver 1.1
The purpose of this double blind randomized study is the evaluation of the safety and efficacy of the Moderato System. The Moderato implantable pulse generator is indicated for patients who have hypertension and also require a…
- Conditions
- Hypertension Resistant to Conventional Therapy, Bradycardia, Atrioventricular Block
- Trial name
- NCT02837445
- Testing
- PHC ON, PHC OFF
- Where
- 12 sites in Austria, Belgium and 5 more
- Volunteers
- 70 people
- Sponsor
- BackBeat Medical Inc
Hypertension, Resistant to Conventional Therapy, Atrioventricular Block
Moderato System in Patients With Hypertension
The purpose of this double blind randomized study is the evaluation of the safety and efficacy of the Moderato System. The Moderato implantable pulse generator is indicated for patients who have hypertension and also require a…
- Trial name
- NCT03757377
- Testing
- BackBeat Moderato System, BackBeat Moderato Sytsem
- Where
- 4 sites in Belgium, Lithuania and 1 more
- Volunteers
- 203 people
- Sponsor
- BackBeat Medical Inc
Peripheral Arterial Disease, Symptomatic Femoropopliteal Lesions
The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)
The purpose of this post-market surveillance study will be to evaluate the real-world use of the DETOUR System in treated patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total…
- Trial name
- PTAB1 (NCT06315023)
- Testing
- DETOUR System
- Where
- 10 sites in United States
- Volunteers
- 450 people
- Sponsor
- Endologix
Hepatocellular Carcinoma (HCC)
Computer Guided Microwave Liver Ablation
The goal of this clinical trial is to learn if the intraoperative use of a computer guidance software can improve the success of liver tumor ablation in adults.
- Trial name
- MWA Sim (NCT07226869)
- Testing
- Computer-Assisted Microwave Liver Ablation
- Where
- 2 sites in United States
- Volunteers
- 84 people
- Sponsor
- NE Scientific INC
Depression Severe
Brain Stimulation for Severe Depression
Chronic intracalvarial cortical stimulation is a minimally invasive method involving the neurosurgical placement of an electrode above the inner table of the skull.
- Trial name
- NCT05393622
- Testing
- INTRACALVARIAL PREFRONTAL CORTICAL STIMULATION (IpCS) IN SEVERE TREATMENT-RESISTANT DEPRESSION
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Inner Cosmos Inc
Amyotrophic Lateral Sclerosis, Neuromuscular Disease
Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)
The Connect-One Study is an early feasibility study to obtain preliminary device safety information for the Connexus Brain-Computer Interface (BCI).
- Conditions
- Amyotrophic Lateral Sclerosis, Neuromuscular Disease, Stroke, Tetraplegia/Tetraparesis
- Trial name
- CONNECT-ONE (NCT07357428)
- Testing
- Connexus Brain-Computer Interface
- Where
- 3 sites in United States
- Volunteers
- 2 people
- Sponsor
- Paradromics
Hypertension (HTN)
WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure Control
The WEARABLE-BP study will evaluate the clinical value of obtaining continual measurements using the Aktiia G1 Optical Blood Pressure Monitoring (OBPM) device in hypertensive patients, compared to using a traditional upper arm…
- Trial name
- WEARABLE-BP (NCT07523269)
- Testing
- Aktiia G1 BP monitor for 12 months, Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months
- Where
- United States
- Volunteers
- 164 people
- Sponsor
- Aktiia SA
Amyotrophic Lateral Sclerosis
RAPA-501 Therapy of ALS Expanded Access Protocol
RAPA-501-ALS is an Intermediate-Size Expanded Access Trial of RAPA-501 autologous hybrid TREG/Th2 T stem cells in patients living with amyotrophic lateral sclerosis (pwALS).
- Trial name
- NCT06169176
- Testing
- RAPA-501 Autologous T stem cells
- Where
- 10 sites in United States
- Sponsor
- Rapa Therapeutics LLC
Melanoma Stage III, Melanoma Stage IV
SX-682 Treatment in Subjects With Metastatic Melanoma Concurrently Treated With Pembrolizumab
Cancers attract myeloid-derived suppressor cells (MDSCs) that prevent our own immune responses from destroying the cancer. This study will be the first study to begin to determine if the newly discovered drug SX-682 can block…
- Trial name
- NCT03161431
- Testing
- SX-682, Pembrolizumab
- Where
- 6 sites in United States
- Volunteers
- 77 people
- Sponsor
- Syntrix Biosystems, Inc.