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INSIGHTEC, INC.

🇺🇸United States

Country: 🇺🇸United States

Ownership: -

Employees: -

Market Cap: -

Website

Clinical Trials

EMBRACE Tremor BiFUS

Not Applicable

Recruiting

Conditions: Essential Tremor

First Posted Date: 2025-05-16

Last Posted Date: 2025-05-20

Lead Sponsor: InSightec

Target Recruit Count: 100

Registration Number: NCT06974916

Locations: 🇩🇪
Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH), Kiel, Germany
🇮🇹
Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy
🇪🇸
HM CINAC- Hospital Universitario HM Puerta del Sur, Móstoles, Spain

and more 1 locations

A Prospective, Randomized, Controlled Trial to Test Safety and Effectiveness of Unilateral Exablate MR-guided Focused Ultrasound Subthalamotomy in Patients With Early-Stage Parkinson's Disease

Not Applicable

Recruiting

Conditions: Parkinson Disease

Interventions: Procedure: Exablate MRgFUS subthalamotomy
Drug: Best Medical Treatment

First Posted Date: 2024-09-04

Last Posted Date: 2025-06-18

Lead Sponsor: InSightec

Target Recruit Count: 72

Registration Number: NCT06584383

Locations: 🇨🇱
Pontificia Universidad Catolica de Chile, Santiago, Chile
🇩🇪
Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH), Kiel, Germany
🇪🇸
HM CINAC- Hospital Universitario HM Puerta del Sur, Móstoles, Spain

and more 1 locations

Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG)

Phase 1

Recruiting

Conditions: Brain Tumor

Interventions: Device: Exablate
Drug: Doxorubicin

First Posted Date: 2022-11-29

Last Posted Date: 2025-04-30

Lead Sponsor: InSightec

Target Recruit Count: 10

Registration Number: NCT05630209

Locations: 🇺🇸
Children's National Medical Center, Washington, District of Columbia, United States
🇺🇸
Nicklaus Children's Hospital, Miami, Florida, United States

Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric DIPG

Phase 1

Recruiting

Conditions: Brain Tumor

Interventions: Device: Exablate
Drug: Doxorubicin

First Posted Date: 2022-11-14

Last Posted Date: 2025-04-30

Lead Sponsor: InSightec

Target Recruit Count: 10

Registration Number: NCT05615623

Locations: 🇨🇦
Sunnybrook Research Institute, Toronto, Ontario, Canada

MR-guided Focused Ultrasound Plus GCase

Not Applicable

Recruiting

Conditions: Parkinsons Disease

Interventions: Device: Blood Brain Barrier Disruption - Functional

First Posted Date: 2022-10-04

Last Posted Date: 2024-10-18

Lead Sponsor: InSightec

Target Recruit Count: 14

Registration Number: NCT05565443

Locations: 🇨🇦
Sunybrook Research Institute, Toronto, Ontario, Canada

A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications

Recruiting

Conditions: Neurology
Movement Disorders
Parkinsons Disease

Interventions: Device: Exablate Pallidotomy, Unilateral

First Posted Date: 2022-09-14

Last Posted Date: 2024-05-31

Lead Sponsor: InSightec

Target Recruit Count: 60

Registration Number: NCT05539196

Locations: 🇺🇸
University of Maryland, Baltimore, Baltimore, Maryland, United States
🇺🇸
Weill Cornell Medicine, New York, New York, United States
🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States

and more 2 locations

Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids

Recruiting

Conditions: Uterine Fibroid

Interventions: Device: Body System - Functional

First Posted Date: 2022-05-23

Last Posted Date: 2025-04-30

Lead Sponsor: InSightec

Target Recruit Count: 200

Registration Number: NCT05386615

Locations: 🇨🇳
Shanghai No. 1 Hospital, Shanghai, China
🇺🇸
UCLA, Los Angeles, California, United States
🇺🇸
Stanford University, Stanford, California, United States

and more 3 locations

Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects with GlioBlastoma Brain Tumors

Not Applicable

Recruiting

Conditions: Glioma
Liquid Biopsy
Glioblastoma

Interventions: Device: Focused Ultrasound (Exablate Model 4000)

First Posted Date: 2022-05-20

Last Posted Date: 2024-12-12

Lead Sponsor: InSightec

Target Recruit Count: 57

Registration Number: NCT05383872

Locations: 🇺🇸
Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
🇺🇸
University of California, Los Angeles, Los Angeles, California, United States
🇺🇸
University of California San Francisco, San Francisco, California, United States

and more 15 locations

Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets

Phase 3

Recruiting

Conditions: Brain Tumor
Non Small Cell Lung Cancer

Interventions: Device: Blood Brain Barrier Opening - Oncology
Drug: Pembrolizumab
Drug: Atezolizumab
Drug: Cemiplimab
Drug: Nivolumab
Drug: Iptilimumab

First Posted Date: 2022-04-08

Last Posted Date: 2025-06-08

Lead Sponsor: InSightec

Target Recruit Count: 30

Registration Number: NCT05317858

Locations: 🇺🇸
Rhode Island Hospital, Providence, Rhode Island, United States
🇺🇸
St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
🇺🇸
Miami Cancer Institute at Baptist Health, Miami, Florida, United States

and more 4 locations

Echo-Focusing in Patients With Treatment-Resistant Neurologic and Psychiatric Indications (EF001)

Not Applicable

Not yet recruiting

Conditions: Neurology
Essential Tremor

Interventions: Device: Exablate Neuro Type 1.0 System with Echo Focusing

First Posted Date: 2021-10-22

Last Posted Date: 2022-08-05

Lead Sponsor: InSightec

Target Recruit Count: 46

Registration Number: NCT05089786

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