Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)

August 13, 2026 updated by: Mirati Therapeutics Inc.

A Randomized Study of Two Dosing Regimens of Adagrasib in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation

This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

CA239-0012 is a phase 2 study of adagrasib monotherapy in which patients are randomized between two dosing regimens. The study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID without regard to food versus 400 mg BID with food) in patients with NSCLC with KRAS G12C mutation and who have received prior treatment with a platinum-based regimen and immune checkpoint inhibitor therapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Brazil
      • São Paulo, Brazil, 01509-900
        • Local Institution - 102
      • São Paulo, Brazil, 01509-900
        • Local Institution - 175
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 41950-640
        • Local Institution - 181
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Local Institution - 177
    • Santa Catarina
      • Itajaí, Santa Catarina, Brazil, 88301-220
        • Local Institution - 182
    • São Paulo
      • Belo Horizonte, São Paulo, Brazil, 30360-680
        • Local Institution - 178
  • Croatia
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • Local Institution - 527
    • Primorje-Gorski Kotar County
      • Rijeka, Primorje-Gorski Kotar County, Croatia, 51000
        • Local Institution - 529
  • France
      • Paris, France, 75014
        • Local Institution - 562
      • Quimper, France, 29000
        • Local Institution - 558
      • Saint-Mandé, France, 94163
        • Local Institution - 550
    • Auvergne-Rhône-Alpes
      • Grenoble, Auvergne-Rhône-Alpes, France
        • Local Institution - 559
    • Gironde
      • Pessac, Gironde, France, 33604
        • Local Institution - 556
    • Loire-Atlantique
      • Saint-Herblain, Loire-Atlantique, France, 44800
        • Local Institution - 553
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49933
        • Local Institution - 554
    • Morbihan
      • Lorient, Morbihan, France, 56322
        • Local Institution - 552
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44093
        • Local Institution - 555
    • Poitou-Charentes
      • Poitiers, Poitou-Charentes, France, 86000
        • Local Institution - 557
    • Provence-Alpes-Côte d'Azur Region
      • Nice, Provence-Alpes-Côte d'Azur Region, France, 06000
        • Local Institution - 561
    • Rhône
      • Marseille, Rhône, France, 13915
        • Local Institution - 551
      • Villefranche-sur-Saône, Rhône, France, 69655
        • Local Institution - 560
  • Greece
      • Thessaloniki, Greece, 54639
        • Local Institution - 576
      • Thessaloniki, Greece, 56429
        • Local Institution - 581
    • Achaïa
      • Pátrai, Achaïa, Greece, 265 04
        • Local Institution - 577
    • Attica
      • Athens, Attica, Greece, 11528
        • Local Institution - 575
    • North Aegean
      • Thessaloniki, North Aegean, Greece, 552 36
        • Local Institution - 580
    • Pella
      • Haidari - Athens, Pella, Greece, 12462
        • Local Institution - 579
  • Israel
      • Haifa, Israel, 3109601
        • Local Institution - 627
      • Tel Aviv, Israel, 6423906
        • Local Institution - 626
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 9103102
        • Local Institution - 625
    • Tel Aviv
      • Haifa, Tel Aviv, Israel, 31048
        • Local Institution - 629
      • Tel Aviv, Tel Aviv, Israel, 64239
        • Local Institution - 628
  • Italy
      • Milan, Italy, 20141
        • Local Institution - 779
      • Perugia, Italy, 6132
        • Local Institution - 775
      • Roma, Italy, 00144
        • Local Institution - 776
    • Pesaro E Urbino
      • Pesaro, Pesaro E Urbino, Italy, 61122
        • Local Institution - 778
    • Piedmont
      • Novara, Piedmont, Italy, 28100
        • Local Institution - 777
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Local Institution - 780
  • Japan
    • Ehime
      • Tōon, Ehime, Japan, 791-0295
        • Local Institution - 401
    • Hyôgo [Hyogo]
      • Nishinomiya, Hyôgo [Hyogo], Japan, 663-8501
        • Local Institution - 403
    • Tiba [Chiba]
      • Kashiwa, Tiba [Chiba], Japan, 277-8577
        • Local Institution - 402
    • Ôsaka [Osaka]
      • Osaka, Ôsaka [Osaka], Japan, 541-8567
        • Local Institution - 400
  • Mexico
      • Toluca, Mexico, 50090
        • Local Institution - 125
    • Mexico City
      • Colonia Nápoles, Mexico City, Mexico, 3810
        • Local Institution - 129
      • Colonia Roma, Mexico City, Mexico, 06760
        • Local Institution - 127
  • Netherlands
      • Utrecht, Netherlands, 3543 AZ
        • Local Institution - 801
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1066 CX
        • Local Institution - 800
  • Poland
      • Lublin, Poland, 20-064
        • Local Institution - 653
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-727
        • Local Institution - 650
    • Pomeranian Voivodeship
      • Gdynia, Pomeranian Voivodeship, Poland, 81-519
        • Local Institution - 651
  • Romania
      • Iași, Romania, 700106
        • Local Institution - 733
      • Sibiu, Romania, 550245
        • Local Institution - 725
      • Suceava, Romania, 720214
        • Local Institution - 728
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400641
        • Local Institution - 732
    • Constanța County
      • Ovidiu, Constanța County, Romania, 905900
        • Local Institution - 731
    • Dolj
      • Craiova, Dolj, Romania, 200385
        • Local Institution - 729
      • Craiova, Dolj, Romania, 200746
        • Local Institution - 734
    • Timiș County
      • Timișoara, Timiș County, Romania, 300166
        • Local Institution - 730
  • Serbia
    • Vojvodina
      • Nis, Vojvodina, Serbia, 11000
        • Local Institution - 754
    • Šumadijski Okrug
      • Kragujevac, Šumadijski Okrug, Serbia, 34000
        • Local Institution - 752
  • South Korea
    • Gyeonggido [Kyonggi-do]
      • Goyang-si, Gyeonggido [Kyonggi-do], South Korea, 10408
        • Local Institution - 327
    • Seoul Teugbyeolsi [Seoul-T'ukp
      • Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea, 06273
        • Local Institution - 328
      • Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea, 08308
        • Local Institution - 326
    • Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
      • Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea, 6351
        • Local Institution - 325
  • Spain
      • Barcelona, Spain, 08025
        • Local Institution - 683
      • Barcelona, Spain, 08028
        • Local Institution - 687
      • Barcelona, Spain, 08035
        • Local Institution - 681
      • Madrid, Spain, 28007
        • Local Institution - 675
      • Madrid, Spain, 28033
        • Local Institution - 679
      • Madrid, Spain, 28040
        • Local Institution - 688
      • Seville, Spain, 41009
        • Local Institution - 682
      • Valencia, Spain, 46010
        • Local Institution - 677
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Local Institution - 680
    • Andalusia
      • Málaga, Andalusia, Spain, 29010
        • Local Institution - 678
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07120
        • Local Institution - 685
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Local Institution - 676
  • Taiwan
    • Kaohsiung
      • Kaohsuing City, Kaohsiung, Taiwan, 833401
        • Local Institution - 352
    • Taichung
      • Taichung, Taichung, Taiwan, 402306
        • Local Institution - 353
      • Taichung, Taichung, Taiwan, 404327
        • Local Institution - 179
      • Taichung, Taichung, Taiwan, 404327
        • Local Institution - 350
  • Thailand
      • Khon Kaen, Thailand, 40002
        • Local Institution - 375
      • Songkhla, Thailand, 90110
        • Local Institution - 378
    • Chiang Mai
      • Muang, Chiang Mai, Thailand, 50200
        • Local Institution - 376
    • Krung Thep Maha Nakhon [Bangko
      • Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand, 10700
        • Local Institution - 377
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06200
        • Local Institution - 704
      • Ankara, Turkey (Türkiye), 06680
        • Local Institution - 701
      • Ankara, Turkey (Türkiye), 06800
        • Local Institution - 706
      • Edirne, Turkey (Türkiye), 22030
        • Local Institution - 700
      • Istanbul, Turkey (Türkiye), 34722
        • Local Institution - 707
      • Izmir, Turkey (Türkiye), 35100
        • Local Institution - 708
    • Ankara/Cankaya
      • Ankara, Ankara/Cankaya, Turkey (Türkiye), 06520
        • Local Institution - 705
    • Etlik/Ankara
      • Ankara, Etlik/Ankara, Turkey (Türkiye), 06010
        • Local Institution - 702
    • Samsun
      • Istanbul, Samsun, Turkey (Türkiye), 34214
        • Local Institution - 709
      • Istanbul, Samsun, Turkey (Türkiye), 34846
        • Local Institution - 710
  • United States
    • California
      • Santa Rosa, California, United States, 95403
        • Local Institution - 101
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Local Institution - 105
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Local Institution - 100
    • Texas
      • Dallas, Texas, United States, 75216-7167
        • Local Institution - 106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Are at least 18 years old (or old enough to legally make their own treatment decisions, according to local laws).
  • Have advanced NSCLC or metastatic NSCLC (NSCLC that started in the lungs and then spread to other parts of the body) with the KRAS G12C mutation.
  • Have had previous treatment with 1) chemotherapy that included a drug called cisplatin or a drug called carboplatin and 2) a type of drug called an immune checkpoint inhibitor.
  • Have recovered from their prior treatment and blood tests are within a safe range.

Key Exclusion Criteria:

  • Have had previous treatment with a drug that targets KRAS G12C.
  • Have cancer that can potentially be removed with surgery.
  • Patients with brain lesions are not eligible if 1) any untreated brain lesions are > 2.0 cm in size 2) any brainstem lesions are present 3) ongoing steroid dosing >10 mg daily prednisone (or equivalent) and 4) poorly controlled (> 1/week) generalized or complex partial seizures or neurologic progression/instability due to brain lesions.
  • Have certain medical conditions or need to take certain medications that, in the opinion of a trial doctor, could make it unsafe for them to participate or difficult to complete the trial assessments, or are pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Adagrasib 600mg BID
Adagrasib 600mg BID without regard to food
Drug: Adagrasib
KRAS G12C inhibitor
Other Names:
  • MRTX849
  • Krazati
Experimental: Adagrasib 400mg BID
Adagrasib 400mg BID with food
Drug: Adagrasib
KRAS G12C inhibitor
Other Names:
  • MRTX849
  • Krazati

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Time Frame: 30 months
ORR evaluation of subjects treated with adagrasib 600 mg BID without regard to food versus 400 mg BID with food having NSCLC with KRAS G12C mutation (Study Population) will be completed per blinded independent central radiology (BICR) review. Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of adagrasib until last dose of adagrasib.
30 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate Overall Survival (OS).
Time Frame: 45 months
Overall survival is defined as time from date of randomization to date of death due to any cause.
45 months
Evaluate Progression Free Survival (PFS).
Time Frame: 30 months
Progression-free survival is defined as time from date of randomization to date of first progression per RECIST 1.1 or death from any cause, whichever occurs first.
30 months
Evaluate Duration of Response (DOR).
Time Frame: 30 months
Duration of response defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either PD (per BICR review) or death due to any cause, whichever occurs first.
30 months
Safety and tolerability in the study population.
Time Frame: 30 months

Safety characterized by number of participants with AEs, with abnormal laboratory test results and number of patients modifying or discontinuing study treatment due to an AE:

  1. Type, incidence, severity, timing, seriousness, and relationship to study treatment of Adverse Events.
  2. Laboratory abnormalities as measured by changes in lab results such as hematologic or chemistry parameters while on study treatment.
  3. Number of patients modifying or discontinuing study treatment due to Adverse Event.
30 months
Population pharmacokinetic (PK) Model Derived Area Under the Curve During the Dosing Interval at Steady State (AUCtau,ss).
Time Frame: Pre-dose and 4-6 hours post dose; up to 6 months.
Sparse concentration data from this study will be pooled with other studies and analyzed using population PK methods to derive individual exposure parameters. Data for this Outcome Measure will not be reported here since ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Pre-dose and 4-6 hours post dose; up to 6 months.
Patient-reported symptoms during adagrasib administration from first dose to 28 days after last dose of adagrasib.
Time Frame: 30 months
Patient reported outcomes (PROs) will be used to assess symptomatic toxicity of adagrasib using the NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Measurement System. PRO items reflect the specific symptom 1) frequency, severity, interference with usual or daily activities, 2) amount, or 3) presence or absence. PRO-CTCAE responses are scored from 0 (low) to 4 (high), or 0/1 for absent/present, and scores for each attribute (frequency, severity and/or interference) are presented descriptively.
30 months
Patient -reported quality of life during adagrasib administration from first dose to End of Treatment visit.
Time Frame: 30 months
Patient reported quality of life questionnaire will be used to assess five dimensions of patient health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using the 5-Level EQ-5D version (EQ-5D-5L) established by the EuroQol Group. This is presented descriptively, and patient responses correspond to a value of 1 (low) or 5 (high). Additionally, a one- page Visual Analog Scale (VAS) will be provided to patients so they may report their self-rated health from the best (100) and worst (0) health imaginable.
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mirati Therapeutics Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA239-0012 (Other Identifier: Bristol-Myers Squibb Protocol ID)
  • 849-021 (Other Identifier: Mirati Therapeutics Protocol ID)
  • 2023-503523-25 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings