Continuous Adductor Canal Infusion vs. Single-injection Adductor Canal Block for Total Knee Arthroplasty

March 9, 2023 updated by: Taipei Veterans General Hospital, Taiwan

Multimodal Analgesia for Unilateral Total Knee Arthroplasty: Impact of Continuous Adductor Canal Infusion Combined With NSAID vs. Intravenous Morphine Patient-controlled Analgesia Combined With Single-injection Adductor Canal Block

Multimodal analgesia (MMA) has been endorsed to improve postoperative analgesia and functional activity after surgery, and integrating regional analgesia to reduce the consumption of opioid has also been used in postoperative pain management. The investigator try to find a better combination of MMA for postoperative analgesia and functional recovery for patients receiving TKA in Taiwan, therefore the effect of single-injection and continuous infusion of peripheral nerve block is compared in patient undergoing unilateral TKA. The investigators hypothesize that continuous adductor canal infusion is as effective as single-injection adductor canal block for postoperative pain relief under intravenous PCA after TKA surgery. Based on that, the investigators conduct this prospective, randomized controlled trial to examine our hypothesis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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

The study compares the effect of two multimodal analgesia protocols, the one integrating IVPCA morphine with single-injection adductor canal block and the other integrating continuous adductor canal infusion with timely administered intravenous tenoxicam, on postoperative analgesia and functional activity after TKA. To assess the outcome of both modalities, The investigators can have more comparative result of pain score and other functional parameters like range of motion of knee joint and muscle strength. Based on that, the investigators try to find a better multimodal analgesic approach for postoperative analgesia and functional recovery for patients receiving TKA in Taiwan. The investigators hypothesize that multimodal analgesia using continuous adductor canal infusion and intravenous tenoxicam are as effective as another modality using IVPCA and single-injection adductor canal block for postoperative pain relief after TKA surgery. However, continuous adductor canal infusion integrated with intravenous tenoxicam might reduce the occurrence of opioid-related side effect and enhance the functional recovery. Based on that, the investigators conduct this prospective, randomized controlled trial to examine our hypothesis.

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 (Anticipated)

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.
80

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.
  • 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 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.

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
        • Contact:

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

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Clinical diagnosis of knee osteoarthritis
  • Must be aged between 20 to 90 years old
  • Must be scheduled for unilateral total knee arthroplasty surgery
  • Must agree to enroll into the clinical trial and have signed the written informed consent

Exclusion Criteria:

  • American Society of Anesthesiologists physical status class IV-V
  • Elevated liver enzymes or liver failure
  • Renal dysfunction (serum creatinine level ≥ 1.5 mg/dL)
  • Cardiac failure
  • Organ transplantation recipient
  • Stroke
  • Major neurological deficit with lower extremity muscle weakness
  • Sensory and motor disorders in lower limb
  • Coagulopathy or thrombocytopenia
  • Previous drug dependency
  • Patients who used illicit drugs within six months
  • Chronic use of opioids
  • Allergy to local anesthetics and drug used in experiment
  • Inability to walk independently
  • Inability to comprehend pain assessment
  • Refusal for implanting a continuous peripheral nerve catheter
  • Refusal for enrolling in study

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: 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.
Active Comparator: Single-injection ACB combined with IV-PCA morphine
Allocation of which participant is to receive single-injection adductor canal block combined with intravenous morphine patient-controlled analgesia (IV-morphine PCA) is determined by randomization, using a computer-generated random sequence and opaque sealed envelopes. After completion of the TKA surgery and surgical suturing, adductor canal block will be performed by an anesthesiologist. Under ultrasound guidance, the femoral artery and the saphenous nerve are identified in the middle one-third of the thigh, deep to the sartorious muscle in the adductor canal. The sartorious and adductor muscles form the roof and the floor of the canal, respectively. Following skin infiltration, 20 mL of 0.25% bupivacaine with 1:400000 epinephrine is injected through a 3-inch, 23-gauge, short bevel block needle. Finally, the IV-morphine PCA will be connected to the intravenous catheter of the patient for postoperative pain management.
Behavioral: Pain scores (numerical rating scale at rest and motion): will be assessed with numerical rating scale at both rest and motion on both knees.
Pain scores will be assessed with numerical rating scale at both rest and motion on both knees.
Other: Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale
For the functional assessment both before and after TKA surgery.
Behavioral: Rehabilitation physiotherapy
Rehabilitation physiotherapy will be assessed with knee range of motion (both active and maximal passive), muscle power at abduction and adduction, single leg stance test, six-minute walk test for assessment of the functional recovery of both knees.
Active Comparator: Continuous adductor canal infusion combined with intravenous NSAID
Allocation of which participant is to receive continuous adductor canal infusion in combination with intermittent intravenous non-steroidal anti-inflammatory drug (NSAID) is determined by randomization, using a computer-generated random sequence and opaque sealed envelopes. After completion of the TKA surgery and surgical suturing, a peripheral nerve catheter will be implanted into adductor canal by an anesthesiologist. Under ultrasound guidance, the femoral artery and the saphenous nerve are identified in the middle one-third of the thigh, deep to the sartorious muscle in the adductor canal. The sartorious and adductor muscles form the roof and the floor of the canal, respectively. Following the peripheral nerve catheter is implanted, 20 mL of 0.25% bupivacaine with 1:400000 epinephrine is injected through the catheter. Intravenous tenoxicam 20 mg for a total amount of 3 doses at 24-hour interval after surgery will be added in the postoperative pain management.
Behavioral: Pain scores (numerical rating scale at rest and motion): will be assessed with numerical rating scale at both rest and motion on both knees.
Pain scores will be assessed with numerical rating scale at both rest and motion on both knees.
Other: Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale
For the functional assessment both before and after TKA surgery.
Behavioral: Rehabilitation physiotherapy
Rehabilitation physiotherapy will be assessed with knee range of motion (both active and maximal passive), muscle power at abduction and adduction, single leg stance test, six-minute walk test for assessment of the functional recovery of both knees.

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
Change in Pain scores at rest and motion
Time Frame: Baseline (day of admission)
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Baseline (day of admission)
Change in Pain scores at rest and motion
Time Frame: Hour 2 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Hour 2 after surgery
Change in Pain scores at rest and motion
Time Frame: Hour 8 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Hour 8 after surgery
Change in Pain scores at rest and motion
Time Frame: Hour 24 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Hour 24 after surgery
Change in Pain scores at rest and motion
Time Frame: Hour 36 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Hour 36 after surgery
Change in Pain scores at rest and motion
Time Frame: Hour 48 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Hour 48 after surgery
Change in Pain scores at rest and motion
Time Frame: Hour 60 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Hour 60 after surgery
Change in Pain scores at rest and motion
Time Frame: Hour 72 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Hour 72 after surgery
Change in Pain scores at rest and motion
Time Frame: 1 day of discharge
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
1 day of discharge
Change in Pain scores at rest and motion
Time Frame: Month 3 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Month 3 after surgery

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
Adverse events
Time Frame: Hour 2 after surgery
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Hour 2 after surgery
Adverse events
Time Frame: Hour 8 after surgery
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Hour 8 after surgery
Adverse events
Time Frame: Hour 24 after surgery
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Hour 24 after surgery
Adverse events
Time Frame: Hour 36 after surgery
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Hour 36 after surgery
Adverse events
Time Frame: Hour 48 after surgery
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Hour 48 after surgery
Adverse events
Time Frame: Hour 60 after surgery
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Hour 60 after surgery
Adverse events
Time Frame: Hour 72 after surgery
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Hour 72 after surgery
Adverse events
Time Frame: Month 3 after surgery
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Month 3 after surgery
Rehabilitation physiotherapy: Knee flexion angle
Time Frame: Baseline (day of admission)
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Baseline (day of admission)
Rehabilitation physiotherapy: Knee flexion angle
Time Frame: Hour 24 after surgery
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Hour 24 after surgery
Rehabilitation physiotherapy: Knee flexion angle
Time Frame: Hour 72 after surgery
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Hour 72 after surgery
Rehabilitation physiotherapy: Knee flexion angle
Time Frame: 1 Day of discharge
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
1 Day of discharge
Rehabilitation physiotherapy: Knee flexion angle
Time Frame: Month 3 after surgery
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Month 3 after surgery
Rehabilitation physiotherapy: knee muscle strength
Time Frame: Baseline (day of admission)
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Baseline (day of admission)
Rehabilitation physiotherapy: knee muscle strength
Time Frame: Hour 24 after surgery
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Hour 24 after surgery
Rehabilitation physiotherapy: knee muscle strength
Time Frame: Hour 72 after surgery
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Hour 72 after surgery
Rehabilitation physiotherapy: knee muscle strength
Time Frame: 1 day of discharge
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
1 day of discharge
Rehabilitation physiotherapy: knee muscle strength
Time Frame: Month 3 after surgery
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Month 3 after surgery
Rehabilitation physiotherapy: Six minute walk test
Time Frame: Baseline (day of admission)
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Baseline (day of admission)
Rehabilitation physiotherapy: Six minute walk test
Time Frame: Hour 24 after surgery
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Hour 24 after surgery
Rehabilitation physiotherapy: Six minute walk test
Time Frame: Hour 72 after surgery
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Hour 72 after surgery
Rehabilitation physiotherapy: Six minute walk test
Time Frame: 1 date of discharge
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
1 date of discharge
Rehabilitation physiotherapy: Six minute walk test
Time Frame: Month 3 after surgery
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Month 3 after surgery
Rehabilitation physiotherapy: Single leg stance test
Time Frame: Baseline (day of admission)
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
Baseline (day of admission)
Rehabilitation physiotherapy: Single leg stance test
Time Frame: Hour 24 after surgery
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
Hour 24 after surgery
Rehabilitation physiotherapy: Single leg stance test
Time Frame: Hour 72 after surgery
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
Hour 72 after surgery
Rehabilitation physiotherapy: Single leg stance test
Time Frame: 1 day of discharge
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
1 day of discharge
Rehabilitation physiotherapy: Single leg stance test
Time Frame: Month 3 after surgery
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
Month 3 after surgery
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
Time Frame: Baseline (day of admission)
For functional pain assessment
Baseline (day of admission)
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
Time Frame: 1 day of discharge
For functional pain assessment
1 day of discharge
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
Time Frame: Month 3 after surgery
For functional pain assessment
Month 3 after surgery
Functional questionnaire: Brief pain inventory (BPI) short form
Time Frame: Baseline (day of admission)
For functional pain assessment
Baseline (day of admission)
Functional questionnaire: Brief pain inventory (BPI) short form
Time Frame: 1 day of discharge
For functional pain assessment
1 day of discharge
Functional questionnaire: Brief pain inventory (BPI) short form
Time Frame: Month 3 after surgery
For functional pain assessment
Month 3 after surgery
Functional questionnaire: Lower extremity functional scale
Time Frame: Baseline (day of admission)
Scoring scales from 0 to 80 with the maximum score being 80 and the lower score meaning the the greater disability.
Baseline (day of admission)
Functional questionnaire: Lower extremity functional scale
Time Frame: 1 date of discharge
Scoring scales from 0 to 80 with the maximum score being 80 and the lower score meaning the the greater disability.
1 date of discharge
Functional questionnaire: Lower extremity functional scale
Time Frame: Month 3 after surgery
Scoring scales from 0 to 80 with the maximum score being 80 and the lower score meaning the the greater disability.
Month 3 after surgery
Adverse events
Time Frame: Baseline (day of admission)
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Baseline (day of admission)
Adverse events
Time Frame: 1 day of discharge
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
1 day of discharge

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.
Taipei Veterans General Hospital, Taiwan

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 Chair: Hsu Ma, MD, PhD, Institutional Review Board, Taipei Veterans General Hospital

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.
May 21, 2019

Primary Completion (Anticipated)

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.
May 31, 2023

Study Completion (Anticipated)

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.
June 30, 2023

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).
May 23, 2022

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.
December 30, 2022

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.
January 3, 2023

Study Record Updates

Last Update Posted (Estimate)

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.
March 10, 2023

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.
March 9, 2023

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.
March 1, 2023

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.
  • TPEVGH IRB No.: 2018-08-007A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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