Transforaminal Lumbar Interbody Fusion (TLIF) (TLIF)

May 2, 2024 updated by: Medtronic Spinal and Biologics

Prospective, Randomized, Controlled, Blinded Pivotal Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) At One Or Two Levels Using Infuse™ Bone Graft With an Intervertebral Body Fusion Device and Posterior Supplemental Fixation For The Treatment Of Symptomatic Degenerative Disease Of The Lumbosacral Spine

This is a global, multi-center, prospective, randomized, blinded, controlled pivotal study. Clinical and radiological evaluation will be performed preoperatively and postoperatively up to 24 months; and endpoint success will be determined at 24 months postoperatively.

Overall a maximum of 1017 subjects will be enrolled and treated. The purpose of the study is to provide safety and effectiveness data of Infuse™ in A Transforaminal Lumbar Interbody Fusion (TLIF) procedures and to obtain indication expansion for Infuse™ use in one and two level TLIF procedures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1017

Phase

  • Not Applicable

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 Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University Third Hospital
        • Principal Investigator:
          • Weishi Li
        • Sub-Investigator:
          • Woquan Zhong
        • Contact:
        • Sub-Investigator:
          • Shuai Jiang
        • Sub-Investigator:
          • Da Zou
        • Sub-Investigator:
          • Shengfa Pan
        • Sub-Investigator:
          • Xin Chen
        • Sub-Investigator:
          • Feifei Zhou
        • Sub-Investigator:
          • Li Zhang
        • Sub-Investigator:
          • Xinhu Guo
        • Sub-Investigator:
          • Liang Jiang
        • Sub-Investigator:
          • Fengshan Zhang
        • Sub-Investigator:
          • Zhuoran Sun
        • Sub-Investigator:
          • Chuiguo Sun
        • Sub-Investigator:
          • Qiang Qi
        • Sub-Investigator:
          • Yan Zeng
        • Sub-Investigator:
          • Zhaoqing Guo
      • Chengdu, China
        • Recruiting
        • West China Hospital of Sichuan University
        • Principal Investigator:
          • Yueming Song
        • Sub-Investigator:
          • Lei Wang
        • Contact:
          • Liping Xiao
          • Phone Number: +86 15308315280
        • Sub-Investigator:
          • Chunguang Zhou
        • Sub-Investigator:
          • Liang Wang
        • Sub-Investigator:
          • Quan Gong
        • Sub-Investigator:
          • Hua Chen
        • Sub-Investigator:
          • Ganjun Feng
        • Sub-Investigator:
          • Tao Li
        • Sub-Investigator:
          • Peng Xiu
        • Sub-Investigator:
          • Limin Liu
        • Sub-Investigator:
          • Bangsheng Jia
        • Sub-Investigator:
          • Yuxiao Deng
        • Sub-Investigator:
          • Xi Yang
        • Sub-Investigator:
          • Zhongjie Zhou
      • Chongqing, China, 400000
        • Recruiting
        • Chongqing Xinqiao Hospital Second Affiliated Hospital of Army Medical University
        • Sub-Investigator:
          • Yu Tang
        • Contact:
        • Principal Investigator:
          • Changqing Li
        • Sub-Investigator:
          • Chao Zhang
        • Sub-Investigator:
          • He Zhang
        • Sub-Investigator:
          • Rui Zuo
        • Sub-Investigator:
          • Zhilei Hu
        • Sub-Investigator:
          • Minghan Liu
        • Sub-Investigator:
          • Chao Liu
        • Sub-Investigator:
          • Xian Chang
        • Sub-Investigator:
          • Huan Liu
        • Sub-Investigator:
          • Jian Wang
        • Sub-Investigator:
          • Wenjie Zheng
        • Sub-Investigator:
          • Yue Zhou
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Jamal McClendon
        • Sub-Investigator:
          • Chandan Krishna
      • Phoenix, Arizona, United States, 85027
        • Recruiting
        • Barrow Brain and Spine, HonorHealth
        • Contact:
        • Principal Investigator:
          • Rory Murphy, MD
    • California
      • Irvine, California, United States, 92617
        • Recruiting
        • University of California Irvine
        • Contact:
        • Principal Investigator:
          • Michael Oh
        • Sub-Investigator:
          • Kiarash Golshani
        • Sub-Investigator:
          • Frank Hsu
      • Laguna Hills, California, United States, 92653
        • Recruiting
        • Memorial Health Services
        • Contact:
        • Principal Investigator:
          • Robert Jackson
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Spine Center
        • Contact:
        • Principal Investigator:
          • Hyun Bae
      • Sacramento, California, United States, 95816
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Contact:
        • Principal Investigator:
          • Christopher Kleck
        • Sub-Investigator:
          • Vikas Patel
        • Sub-Investigator:
          • Nolan Wessel
      • Boulder, Colorado, United States, 80303
        • Recruiting
        • Boulder Neurosurgical Associates and Justin Parker Neurological Institute/E. Lee Nelson
        • Contact:
        • Sub-Investigator:
          • Sharad Rajpal, MD
        • Principal Investigator:
          • Alan Villavicencio, MD
        • Sub-Investigator:
          • Ewell Nelson, MD
      • Vail, Colorado, United States, 81657
        • Recruiting
        • Vail-Summit Orthopaedics and Neurosurgery
        • Contact:
        • Principal Investigator:
          • Ernest Braxton
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Recruiting
        • Hartford Hospital
        • Contact:
        • Principal Investigator:
          • Heeren Makanji, MD
        • Sub-Investigator:
          • Hanbing Zhou, MD
    • Florida
      • Altamonte Springs, Florida, United States, 32701
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health
        • Contact:
        • Principal Investigator:
          • Virgilio Matheus, MD
        • Sub-Investigator:
          • Robert A Hirschl, MD
        • Sub-Investigator:
          • Marshall C Cress, MD
        • Sub-Investigator:
          • Paul M Foreman, MD
      • Orlando, Florida, United States, 32803
      • Tampa, Florida, United States, 33637
        • Recruiting
        • Foundation for Orthopaedic Research and Education
        • Contact:
        • Principal Investigator:
          • John Small
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
        • Principal Investigator:
          • Harel Deutsch
      • Chicago, Illinois, United States, 60611
        • Withdrawn
        • Northwestern Medicine
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Recruiting
        • Goodman Campbell Brain and Spine
        • Contact:
        • Principal Investigator:
          • Saad Khairi
        • Sub-Investigator:
          • Shannon McCanna
        • Sub-Investigator:
          • Eric Potts
        • Sub-Investigator:
          • Richard Rodgers
        • Sub-Investigator:
          • John DePowell
        • Sub-Investigator:
          • Charles Kulwin
        • Sub-Investigator:
          • Eric Horn
      • Carmel, Indiana, United States, 46032
        • Recruiting
        • Indiana Spine Group
        • Principal Investigator:
          • Joseph Smucker, MD
        • Contact:
      • Indianapolis, Indiana, United States, 46278
        • Terminated
        • OrthoIndy Northwest Office
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Withdrawn
        • University of Kansas Medical Center Research Institute
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Recruiting
        • Lahey Hospital & Medical Center
        • Principal Investigator:
          • Zoher Ghogawala, MD
        • Contact:
      • Springfield, Massachusetts, United States, 01199
        • Active, not recruiting
        • Baystate Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Health System
        • Contact:
        • Principal Investigator:
          • Yamaan Saadeh
        • Sub-Investigator:
          • Osama Kashlan
      • Royal Oak, Michigan, United States, 48073
        • Terminated
        • William Beaumont Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55901
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Brett Freedman
        • Sub-Investigator:
          • Benjamin Elder
        • Sub-Investigator:
          • Jeremy Fogelson
        • Sub-Investigator:
          • Arjun Sebastian
        • Sub-Investigator:
          • Mohamed Bydon
        • Contact:
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Sub-Investigator:
          • Reza Yassari
        • Principal Investigator:
          • Yaroslav Gelfand
        • Contact:
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital for Special Surgery
        • Contact:
        • Principal Investigator:
          • Darren Lebl
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
        • Principal Investigator:
          • Samuel Cho
        • Sub-Investigator:
          • Jun Kim
      • New York, New York, United States, 10003
        • Withdrawn
        • NYU Langone Health
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
        • Contact:
        • Principal Investigator:
          • Cheerag Upadhyaya
    • Ohio
      • Cincinnati, Ohio, United States, 45209
        • Recruiting
        • Mayfield Brain and Spine Clinic
        • Contact:
        • Principal Investigator:
          • Robert Bohinski
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Principal Investigator:
          • Stephanus Viljoen, MD
        • Sub-Investigator:
          • Andrew Grossbach, MD
        • Sub-Investigator:
          • David Xu
        • Contact:
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State-Hershey
        • Contact:
        • Principal Investigator:
          • George Reiter, MD
        • Sub-Investigator:
          • Michael Sather, MD
        • Sub-Investigator:
          • JP Kelleher, MD
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Rothman Institute
        • Principal Investigator:
          • Gregory Schroeder
        • Sub-Investigator:
          • Victor Hsu
        • Contact:
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Not yet recruiting
        • Semmes Murphey
        • Contact:
        • Principal Investigator:
          • Sonia Eden, MD
        • Sub-Investigator:
          • Paul Park, MD
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Saint Thomas for Specialty Surgery
        • Contact:
        • Principal Investigator:
          • Jason Hubbard
      • Nashville, Tennessee, United States, 37209
        • Recruiting
        • Tennessee Orthopaedic Alliance
        • Contact:
        • Principal Investigator:
          • Ryan Snowden
    • Texas
      • Austin, Texas, United States, 78731
        • Withdrawn
        • Ascension Texas Spine and Scoliosis
      • Fort Worth, Texas, United States, 76132
        • Recruiting
        • DFW Center for Spinal Disorder
        • Contact:
        • Principal Investigator:
          • Jason Tinley
      • Houston, Texas, United States, 77030
      • Plano, Texas, United States, 75075
    • Virginia
      • Charlottesville, Virginia, United States, 22904
        • Recruiting
        • University of Virginia - Clinical Trial Office
        • Contact:
        • Principal Investigator:
          • Mark Shaffrey
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia - Health System
        • Contact:
        • Principal Investigator:
          • Adam Shimer
        • Sub-Investigator:
          • Francis Shen
        • Sub-Investigator:
          • Anuj Singla
    • Washington
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Neuroscience
        • Contact:
        • Principal Investigator:
          • Jens Chapman
        • Sub-Investigator:
          • Rod Oskouian
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University, 1 Medical Center Drive
        • Contact:
        • Sub-Investigator:
          • John France, MD
        • Sub-Investigator:
          • Cara Sedney, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
        • Principal Investigator:
          • Saman Shabani
        • Sub-Investigator:
          • Brandon Rebholz
        • Sub-Investigator:
          • Aditya Vedantam

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

A subject must meet all of the following inclusion criteria to participate in this study:

  • I.1. Has degenerative disease of the lumbosacral spine in one or two adjacent levels (L2 to S1) that results in radiculopathy secondary to nerve root compression, manifested by:

    1. History of radiating leg or buttock pain, paresthesia, numbness or weakness, or
    2. History of neurogenic claudication.
  • I.2. Has a history of low back pain.

  • I.3. Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative lumbosacral disease including at least one of the following:

    1. Instability up to and including Grade 2 spondylolisthesis/retrolisthesis based on the Meyerding classification (Meyerding, HW, 1932), or lateral listhesis demonstrated by coronal plane translation (slippage) of the superior (cranial) vertebral body lateral to the inferior (caudal) vertebral body less than or equal to 3mm, or
    2. Stenosis, or narrowing, of the lumbar spinal canal and/or intervertebral foramen requiring significant decompression leading to segmental instability, or
    3. Recurrent disc herniation
  • I.4. Has preoperative Oswestry Disability Index score ≥ 35.

Has to meet either inclusion criteria 5 or 6 to qualify for the study:

  • I.5. Has preoperative back and leg pain scores of (back pain ≥ 4 and leg pain ≥ 1) based on the Preoperative Back and Leg Pain Questionnaire.
  • I.6. Has preoperative back and leg pain scores of (back pain ≥ 1 and leg pain ≥ 4) based on the Preoperative Back and Leg Pain Questionnaire.
  • I.7. Is at least 18 years of age and skeletally mature at the time of surgery.
  • I.8. Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of six months.
  • I.9. Is willing and able to comply with the study plan and able to understand and sign the subject Informed Consent Form.

Exclusion Criteria:

A subject will be excluded from participating in this study for any of the following reasons:

  • E.1 Prior surgical procedure at the involved or adjacent spinal levels (e.g. fusion, arthroplasty, and/or other non-fusion procedures). Prior discectomy and/or laminectomy at the target or adjacent levels is allowed.
  • E.2 Significant lumbar instability defined as sagittal listhesis greater than Grade 2 at any involved level using the Meyerding Classification or lateral listhesis greater than 3 mm at any involved level.
  • E.3 Planned use of an internal or external bone growth stimulator.
  • E.4 Lumbar scoliosis >30 degrees.
  • E.5 Patients who had a previous diagnosis of osteoporosis with a T-score of -2.5 or below in the last 12 months existing together with a prevalent fragility fracture. (If subject has a prevalent fragility fracture and a T-score hasn't been assessed in the last 12 months, a DEXA will need to be obtained.)
  • E.6 Morbidly obese, as defined by a Body Mass Index (BMI) >40.
  • E.7 Presence of active malignancy or prior history of malignancy (non-invasive basal cell carcinoma of the skin and non-invasive squamous cell carcinoma localized only to the skin is allowed).
  • E.8 Overt or active bacterial infection, either local to surgical space or systemic.

  • E.9 Has undergone administration of any type of corticosteroid, antineoplastic, immunostimulating, or immunosuppressive agents, or medications known to inhibit the healing of bone or soft tissue within 30 days prior to implantation of the assigned treatment.

    • This includes patients ≥ 65 years of age taking warfarin with documented diagnosed osteoporosis. All other patients taking warfarin should washout for at least 5 days prior to treatment
    • Use of steroidal inhalers is allowed pre- and post-operatively
    • Short-term steroidal use (e.g., Medrol Dosepak) is allowed pre and post-operatively. For this clinical study, short-term use is defined as ≤ two weeks. Use of steroids for longer than two weeks post-operatively through the 24-month follow-up visit is prohibited.
  • E.10 Co-morbidities, which in the investigator's opinion, precludes the subject from being a surgical candidate.
  • E.11 Autoimmune disease, which in the investigator's opinion, is known to affect bone metabolism or the spine (e.g., spondyloarthropathies, juvenile arthritis, rheumatoid arthritis, Graves' disease, Hashimoto's thyroiditis).
  • E.12 Any endocrine or metabolic disorder, which in the investigator's opinion, is known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
  • E.13 Known exposure to any recombinant proteins used for bone formation (e.g., Infuse™ Bone Graft, OP-1 Putty, OP-1 Implant, AUGMENT Bone Graft, GEM21S, i-FACTOR Peptide Enhanced Bone Graft, or PepGen P-15 Synthetic Bone Graft).
  • E.14 Known hypersensitivity or allergy to any components of the study treatments including, but not limited to bone morphogenetic proteins (BMPs); injectable collagen; protein pharmaceuticals (e.g.,monoclonal antibodies or gamma globulins); bovine collagen products; and/or instrumentation materials (e.g., titanium, titanium alloy, cobalt chrome, cobalt chrome alloy, or PEEK).
  • E.15 History of any allergy resulting in anaphylaxis.
  • E.16 Is a prisoner.
  • E.17 Is mentally incompetent. If questionable, obtain psychiatric consult.
  • E.18 Treatment with an investigational therapy (drug, device, and/or biologic) targeting spinal conditions within 3 months prior to implantation surgery, treatment with any other investigational therapies within 30 days prior to implantation surgery, or such treatment is planned during the 24-month period following implantation of the study treatment.
  • E.19 Pregnant or nursing. Females of child-bearing potential must agree not to become pregnant for 24 months following surgery.
  • E.20 A documented diagnosis of substance use disorder as defined by the DSM-5.22 (Nicotine use is allowed.)
  • E.21 Pursuing worker's compensation or active litigation for spinal fusion procedure.
  • E.22 Any condition, which in the investigator's opinion, would interfere with the subject's ability to comply with study instructions, which might confound data interpretation.

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group #1
Investigational Infuse™ 2.1 mg/level with available local bone autograft and supplemented with cancellous allograft as needed
Device: Infuse™ Bone Graft (Infuse™)
(Recombinant human bone morphogenetic protein-2 (rhBMP-2)/absorbable collagen sponge (ACS))
Device: Intervertebral body fusion device and Medtronic posterior Fixation Systems
Adaptix™Interbody System, Capstone™ Spinal System, Catalyft™ PL Interbody System
Experimental: Group #2
Investigational Infuse™ 4.2 mg/level with available local bone autograft and supplemented with cancellous allograft as needed
Device: Infuse™ Bone Graft (Infuse™)
(Recombinant human bone morphogenetic protein-2 (rhBMP-2)/absorbable collagen sponge (ACS))
Device: Intervertebral body fusion device and Medtronic posterior Fixation Systems
Adaptix™Interbody System, Capstone™ Spinal System, Catalyft™ PL Interbody System
Active Comparator: Control
Local bone autograft and supplemented with cancellous allograft as needed.
Device: Intervertebral body fusion device and Medtronic posterior Fixation Systems
Adaptix™Interbody System, Capstone™ Spinal System, Catalyft™ PL Interbody System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall success at 24 months
Time Frame: 24 months

Overall success is defined as the participant who meet the following five criteria:

  • Pain/disability (ODI) success, defined as at least a 15-point improvement from baseline;
  • Fusion success as defined in primary outcome 2.
  • Neurological success, defined as maintenance or improvement in neurological status;
  • No SAE related to the TLIF grafting material or interbody device; and
  • No secondary surgeries at index level that are related to the TLIF grafting material or interbody device
24 months
Fusion success at 24 months
Time Frame: 24 Months

Fusion success at each treatment level must demonstrate:

  • Evidence of bridging bone via CT. Solid fusion is based on evidence of continuous bone bridging from the superior to the inferior vertebral body at the target level(s) in at least 1 of the following locations: right lateral, left lateral, anterior, posterior, or through the PEEK implant.
  • No evidence of motion as defined by less than 3mm translational motion and less than 5o in angular motion at each treated level
24 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to fusion
Time Frame: From surgery to 24 Months
The first time point when a subject's fusion status has been determined to be a success per the fusion success criteria
From surgery to 24 Months
ODI success
Time Frame: 24 months
The self-administered Oswestry Disability Index (ODI) will be used. The ODI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Success will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score ≥ 15 points
24 months
Leg pain success
Time Frame: 24 months
Numerical rating scales (NRS 0-10) will be used to measure leg pain, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be. Success for leg pain is defined as at least 20% improvement from pre-operative score: (Preoperative Score - Postoperative Score) / Preoperative Score ≥ 20%
24 months
Back pain success
Time Frame: 24 months
Numerical rating scales (NRS 0-10) will be used to measure back pain, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be". Success for back pain is defined as at least 20% improvement from pre-operative score: (Preoperative Score - Postoperative Score) / Preoperative Score ≥ 20%
24 months
Neurological success
Time Frame: 24 months
Overall neurological success is defined as maintenance or improvement in four key neurological assessments: motor function, sensory function, reflexes, and straight leg raise. In order to be considered a success, each element in the motor, sensory, reflexes, and straight leg raise examinations must remain the same or improve from the time of the preoperative evaluation to the time period evaluated. Therefore, if any one motor, sensory, or reflexes element does not stay the same or improve, then a subject will not be considered a success for neurological status.
24 months
Serious Adverse Events
Time Frame: up to 24 months
Serious Adverse Events related to TLIF grafting material or interbody device up to 24 months
up to 24 months
Secondary Surgery
Time Frame: up to 24 months
Secondary surgeries that are classified as a "failure", defined as any secondary surgeries at index level(s) "related" to TLIF grafting material or interbody device.
up to 24 months

Collaborators and Investigators

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

Sponsor

Medtronic Spinal and Biologics

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)

December 19, 2019

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

August 27, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (Actual)

August 29, 2019

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • MDT17074SD1706

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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.

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