Brain TumorPhase 3LIMITLESSNCT05317858
Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets
A Phase 3 study testing Blood Brain Barrier Opening - Oncology, Pembrolizumab and Atezolizumab in people with Brain Tumor and Non Small Cell Lung Cancer, run by InSightec at 16 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier opening with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned FDA approved, on-label systemic therapy utilizing immune checkpoint inhibitors. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Brain Tumor, Non Small Cell Lung Cancer
- What is being tested?
- Blood Brain Barrier Opening - Oncology, Pembrolizumab and Atezolizumab
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 12 Aug 2022to 1 Dec 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is ≥ 18 years of age
- The participant provides written informed consent for the trial
- Participant is willing to comply with all study procedures for the duration of the study
- Participant has a Karnofsky Performance Status ≥ 70% and/or ECOG 0-2
- Participant is a NSCLC subject prescribed immune checkpoint inhibitor systemic therapy according to on-label use with the target brain lesion(s) measuring ≥ 0.5 cm in longest diameter. Target mets may include: De novo mets for which surgery and radiation can be deferred, Mets with or without history of prior radiation, Mets with history of radiation after at least 8 weeks since last radiation treatment, and In the event a previously treated met has progressed according to institutional practice within 4 weeks post radiation treatment, the met may be study eligible, and/or if in the opinion of the Investigator, the subject may benefit from the study procedure.
- Female subject is not planning pregnancy during the study duration and confirmed NOT PREGNANT each procedure day.
- Screening/Baseline laboratory values Screening/Baseline should adhere to local standard of care lab values for ICI therapy
Who cannot join
- Participant has evidence of acute intracranial hemorrhage
- Participant at risk for spontaneous intracranial hemorrhage (e.g., history of metastatic melanoma or other tissue histology).
- Participant has signs and symptoms of increased intracranial pressure or symptomatic mass effect, midline shift or evidence of subfalcine, uncal or tonsillar herniation.
- Participant receiving Bevacizumab (Avastin) therapy, or other drugs with a proclivity for causing bleeding.
- History of bleeding disorders or tissue pathologies which increase the subject's risk of hemorrhage for anticoagulation medications, implement pre-surgical standard procedure to avoid increased risk of a bleeding event.
- Participant has an infectious viral infection such as active Hepatitis B, Hepatitis C or detectable HIV viral load or participants with active bacterial infection such as TB (Bacillus tuberculosis) that may, in the opinion of the investigator, interfere with the subject receiving the study therapy or procedures or otherwise impact their participation in the trial.
Show all 18Show fewer
- Subjects with evidence of cranial or systemic infection.
- Participant has received a solid organ or hematopoietic stem cell transplant.
- Participant has received a live vaccine within 28 days prior to the first on-study ICI infusion with or without Exablate.
- Known sensitivity to DEFINITY® ultrasound contrast agent or hypersensitivity to perflutren microsphere or its components, e.g., polyethylene glycol, as found in MiraLAX and bowel prep products.
- Contraindications to MRI and gadolinium-DTPA including non-MRI-compatible implanted devices, severe claustrophobia, unable to lie supine in MRI.
- Subjects with significant liver dysfunction, (cirrhosis, hemochromatosis, severe alcohol abuse, or active hepatitis (autoimmune or infectious))
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first on-study ICI infusion with or without Exablate. Note: prophylactic steroid use for ICI and chemotherapy infusion per institutional practice is allowed per protocol.
- Has a known additional malignancy that requires active treatment that would interfere with study procedures.
- Known presence of leptomeningeal disease.
- Has a diagnosis of active autoimmune disease (e.g., autoimmune Hepatitis, Guillain-Barre Syndrome, etc.) requiring systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. History of (non-infectious) pneumonitis that requires steroids or has current pneumonitis
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Subject is currently enrolled in another intervention based clinical trial
Trial locations and contacts
16 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 3 countries
United States12 sites, 10 recruiting
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
Kaitlyn Henry, 410-328-0939, KHenry@som.umaryland.edu
Rayne Noyes, 410-328-5332, anoyes@som.umaryland.edu
- Recruiting
Duke University
Durham, North Carolina, 27708
Julia Hurrelbrink - Assistant Research Practice Manager, BA, BSN, RN, (919)681-7460, julia.hurrelbrink@duke.edu
Laura Alder, Medical Oncology, Internal Med
- Recruiting
Broward Health
Fort Lauderdale, Florida, 33316
Shirley Cheraime, RN, BSN, 954.712.3904, scheraime@browardhealth.org
Simone Dockery Franklin, Sfranklin@browardhealth.org
- Recruiting
Miami Cancer Institute at Baptist Health
Miami, Florida, 33176
Natalie Brunelle, 786-533-9460, Natalie.Brunelle@Baptisthealth.net
Manmeet S Ahluwalia, MD
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Simon Khagi, MD, MBA, FACP, 949-764-4060, Simon.Khagi@hoag.org
Julie Nguyen, (949) 764-6271, Julie.Nguyen@hoag.org
- Withdrawn
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
- Not yet recruiting
UPMC Presbyterian Hospital - University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Kristy Boggs, PhD, 412-647-8952, boggskd@upmc.edu
Constantinos Hadjipanayis, Neurosurgery
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Michael McGehee, MS, 971-509-4932, nsgclinicalresearch@ohsu.edu
Ahmed Raslan, MBBCh, MSc, MD, FAANS
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Maria Duffy, (401) 444-2243, mduffy@brownhealth.org
Owen Leary, (401) 606-8388, owen.leary@brownhealth.org
- Active, not recruiting
Johnston Willis Hospital
Richmond, Virginia, 23235
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Carie Bliss, (813) 745-2131, Carie.Bliss@moffitt.org
Yolanda Pina, Neuro-Oncology
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27103
Adrian Laxton, BA, MA, MD, FRCSC, FAANS, 336-716-6438, Adrian.Laxton@wfusm.edu
Wendy Jenkins, RN, BSN, 336-716-3842, Wendy.Jenkins@Advocatehealth.org
South Korea3 sites, 3 recruiting
- Not yet recruiting
Samsung Medical Center
Seoul, Seoul, 06351
Kyung-won Chang, +82-10-7209-8001, kyungwon.chang@samsung.com
Kyung-won Chang
- Not yet recruiting
Seoul National University Hospital
Seoul
Eun-jung Lee, +82-10-4110-0121, eunjlee21@snu.ac.kr
Eun-jung Lee
- Not yet recruiting
Severance Hospital, Yonsei University Health System
Soeul
Hyun Ho Jung, +82-10-8797-3815, JUNGHH@yuhs.ac
Hyun Ho Jung
Canada1 site
- Active, not recruiting
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
About this study
Official title: A Randomized Pivotal Study Assessing the Safety and Efficacy of Targeted Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound During the Standard of Care Treatment of Brain Metastases of Non-small Cell Lung Cancer (NSCLC) Origin
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier opening with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned FDA approved, on-label systemic therapy utilizing immune checkpoint inhibitors.
Read the detailed description
This is a prospective, multi-center, randomized, two-arm, controlled, pivotal clinical trial to evaluate the safety and efficacy of targeted blood brain barrier opening using Exablate Model 4000 Type 2 for the treatment of NSCLC brain metastases in subjects who are undergoing planned FDA approved, on-label systemic therapy utilizing immune checkpoint inhibitors for their primary disease. The study will be conducted at up to 30 centers in the US. The immunotherapy regimen (every 3 weeks for 6 cycles) of prescribed ICI therapy is per the FDA approved labeling and the subjects prescribed standard of care therapy for their primary NSCLC. The study aims to demonstrate superiority of Exablate BBBO targeted to their brain metastases over the standard of care without Exablate BBBO with respect to the percentage of subjects achieving Objective Response Rate (ORR) by 6 months follow-up.
- Conditions
- Brain Tumor, Non Small Cell Lung Cancer
- Being tested
- Blood Brain Barrier Opening - Oncology, Pembrolizumab, Atezolizumab, Cemiplimab, Nivolumab
- Keywords
- MRgFUS, NSCLC, Low Frequency Ultrasound
- Medical subject headings
- Brain Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Brain Barrier Opening - OncologyDevice
Also called Exablate BBBO
BBB opening via Exablate Type 2 system with microbubble resonators on the day of ICI infusion to treat brain metastases.
PembrolizumabDrug
Also called KEYTRUDA
Pembrolizumab infusion
AtezolizumabDrug
Also called Tecentriq
Atezolizumab infusion
CemiplimabDrug
Also called LIBTAYO
Cemiplimab infusion
NivolumabDrug
Nivolumab infusion
IptilimumabDrug
Iptilimumab infusion
| Study group | Role | What they receive |
|---|---|---|
| ICI Systemic Therapy with Exablate BBBO | Experimental | Using Exablate Model 4000 Type 2 for the treatment of NSCLC brain metastases in subjects who are undergoing planned ICI Systemic Therapy. Receives: Device: Blood Brain Barrier Opening - Oncology; Drug: Pembrolizumab; Drug: Atezolizumab; Drug: Cemiplimab; Drug: Nivolumab; Drug: Iptilimumab |
| Control Arm (ICI Systemic Therapy on-label use only) | Active comparator | subjects will undergo planned on-label ICI Systemic Therapy. Receives: Drug: Pembrolizumab; Drug: Atezolizumab; Drug: Cemiplimab; Drug: Nivolumab; Drug: Iptilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Adverse events [ Time Frame: Through study completion, up to 6 months]. All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria.
Measured: up to 6 months
tumor lesion(s) on the MRI images
Efficacy will be determined by the response of the tumor lesion(s) compared to baseline. Tumor lesions on the MRI images (units: mm) will be measured every three weeks up to six months.
Measured: up to 6 months
Secondary outcomes (2)
evaluation of Neuro Oncology Brain Mets (RANO-BM) response
The evaluation of the percentages of subjects that achieved the stable disease (SD), partial response (PR) as the best objective response using the response assessment in Neuro Oncology Brain Mets (RANO-BM) response criteria measured at baseline and every 3 weeks during each treatment cycle to up to 6 months of therapy.
Measured: up to 6 months
Time to response for brain metastases by treatment arm [applicable to the completed stage 1a only]
The time to achieve a confirmed complete response or partial response for brain metastases by treatment arm as assessed using the RANO-BM criteria evaluated every 3 weeks up to 6 months during treatment cycles.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start12 Aug 2022
- Primary completion1 Jun 2031 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by InSightecThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multiple staged study design: 1a early feasibility (not randomized, unblinded), 1b feasibility of Pivotal (randomized, blinded, no crossover), 2 Pivotal (randomized, blinded, crossover allowed for eligible control patients with progression of brain mets)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manmeet Ahluwalia, MD, MBA, Principal investigator, Miami Cancer Institute, Baptist Health South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317858
- Sponsor's protocol ID
- BT012
- Acronym
- LIMITLESS
- Status last verified
- Oct 2026
- First submitted
- 1 Mar 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pivotal Study Assessing the Safety and Efficacy of Targeted Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound During the Standard of Care Treatment of Brain Metastases of Non-small Cell Lung Cancer (NSCLC) Origin
- ClinicalTrials.gov ID
- NCT05317858
- Acronym / sponsor ID
- LIMITLESS / BT012
- Conditions
- Brain Tumor, Non Small Cell Lung Cancer
- Keywords
- MRgFUS, NSCLC, Low Frequency Ultrasound
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 1 Jun 2031 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier opening with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned FDA approved, on-label systemic therapy utilizing immune checkpoint inhibitors.
Detailed description
This is a prospective, multi-center, randomized, two-arm, controlled, pivotal clinical trial to evaluate the safety and efficacy of targeted blood brain barrier opening using Exablate Model 4000 Type 2 for the treatment of NSCLC brain metastases in subjects who are undergoing planned FDA approved, on-label systemic therapy utilizing immune checkpoint inhibitors for their primary disease. The study will be conducted at up to 30 centers in the US. The immunotherapy regimen (every 3 weeks for 6 cycles) of prescribed ICI therapy is per the FDA approved labeling and the subjects prescribed standard of care therapy for their primary NSCLC. The study aims to demonstrate superiority of Exablate BBBO targeted to their brain metastases over the standard of care without Exablate BBBO with respect to the percentage of subjects achieving Objective Response Rate (ORR) by 6 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multiple staged study design: 1a early feasibility (not randomized, unblinded), 1b feasibility of Pivotal (randomized, blinded, no crossover), 2 Pivotal (randomized, blinded, crossover allowed for eligible control patients with progression of brain mets)
| Arm | Type | Receives |
|---|---|---|
| ICI Systemic Therapy with Exablate BBBO | Experimental | Device: Blood Brain Barrier Opening - Oncology, Drug: Pembrolizumab, Drug: Atezolizumab, Drug: Cemiplimab, Drug: Nivolumab, Drug: IptilimumabUsing Exablate Model 4000 Type 2 for the treatment of NSCLC brain metastases in subjects who are undergoing planned ICI Systemic Therapy. |
| Control Arm (ICI Systemic Therapy on-label use only) | Active comparator | Drug: Pembrolizumab, Drug: Atezolizumab, Drug: Cemiplimab, Drug: Nivolumab, Drug: Iptilimumabsubjects will undergo planned on-label ICI Systemic Therapy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant is ≥ 18 years of age
- The participant provides written informed consent for the trial
- Participant is willing to comply with all study procedures for the duration of the study
- Participant has a Karnofsky Performance Status ≥ 70% and/or ECOG 0-2
- Participant is a NSCLC subject prescribed immune checkpoint inhibitor systemic therapy according to on-label use with the target brain lesion(s) measuring ≥ 0.5 cm in longest diameter. Target mets may include: De novo mets for which surgery and radiation can be deferred, Mets with or without history of prior radiation, Mets with history of radiation after at least 8 weeks since last radiation treatment, and In the event a previously treated met has progressed according to institutional practice within 4 weeks post radiation treatment, the met may be study eligible, and/or if in the opinion of the Investigator, the subject may benefit from the study procedure.
Key exclusion criteria (18 listed)
- Participant has evidence of acute intracranial hemorrhage
- Participant at risk for spontaneous intracranial hemorrhage (e.g., history of metastatic melanoma or other tissue histology).
- Participant has signs and symptoms of increased intracranial pressure or symptomatic mass effect, midline shift or evidence of subfalcine, uncal or tonsillar herniation.
- Participant receiving Bevacizumab (Avastin) therapy, or other drugs with a proclivity for causing bleeding.
- History of bleeding disorders or tissue pathologies which increase the subject's risk of hemorrhage for anticoagulation medications, implement pre-surgical standard procedure to avoid increased risk of a bleeding event.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Brain Barrier Opening - OncologyAlso: Exablate BBBOBBB opening via Exablate Type 2 system with microbubble resonators on the day of ICI infusion to treat brain metastases. | Device | ICI Systemic Therapy with Exablate BBBO |
| PembrolizumabAlso: KEYTRUDAPembrolizumab infusion | Drug | Control Arm (ICI Systemic Therapy on-label use only), ICI Systemic Therapy with Exablate BBBO |
| AtezolizumabAlso: TecentriqAtezolizumab infusion | Drug | Control Arm (ICI Systemic Therapy on-label use only), ICI Systemic Therapy with Exablate BBBO |
| CemiplimabAlso: LIBTAYOCemiplimab infusion | Drug | Control Arm (ICI Systemic Therapy on-label use only), ICI Systemic Therapy with Exablate BBBO |
| NivolumabNivolumab infusion | Drug | Control Arm (ICI Systemic Therapy on-label use only), ICI Systemic Therapy with Exablate BBBO |
| IptilimumabIptilimumab infusion | Drug | Control Arm (ICI Systemic Therapy on-label use only), ICI Systemic Therapy with Exablate BBBO |
Primary outcome
Adverse events
Time frame: up to 6 months
Adverse events [ Time Frame: Through study completion, up to 6 months]. All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria.
tumor lesion(s) on the MRI images
Time frame: up to 6 months
Efficacy will be determined by the response of the tumor lesion(s) compared to baseline. Tumor lesions on the MRI images (units: mm) will be measured every three weeks up to six months.
2 secondary outcomes
evaluation of Neuro Oncology Brain Mets (RANO-BM) response
Time frame: up to 6 months
Time to response for brain metastases by treatment arm [applicable to the completed stage 1a only]
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Brain Tumor
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manmeet Ahluwalia, MD, MBA principal investigator
Miami Cancer Institute, Baptist Health South Florida
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Blood Brain Barrier Opening - Oncology, Pembrolizumab and Atezolizumab in people with Brain Tumor and Non Small Cell Lung Cancer, run by InSightec at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, South Korea, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alyssa Voelker-Christy (817-948-5219, clinicalresearchquestions@insightec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.