Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC

May 27, 2026 updated by: Melissa Pugliano-Mauro

Phase I, Dual Arm, Open-Label, Trial of Intralesional 5-Fluorouracil (5FU) and Intralesional 5FU Combined With Topical Calcipotriene in Patients With Squamous Cell Carcinoma (SCC) of the Lower Extremities

This clinical trial proposes to evaluate a relatively unexplored approach to treatment of squamous cell carcinoma (SCC) on the lower extremities. The strategy is to directly and specifically deliver drug to the tumor. For the proposed phase I clinical trial, the investigators will perform intralesional injections of a well characterized, potent chemotherapeutic agent 5-fluorouracil (5FU) with and without a topical application of 0.005% calcipotriene cream to kill topically accessible SCC cells. The goal of the study is to evaluate the safety profile and tolerability of intralesional-5FU with and without a concomitant topical calcipotriene and measure the clinical objective response rate (ORR) in treated lesions compared to untreated lesions 3 weeks after treatment.

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

Squamous cell carcinoma of the skin is a common form of keratinocyte skin cancer. The majority of cutaneous SCCs occur on the head and neck, more so in men than women, but can occur anywhere squamous cells are found. Squamous cell carcinoma of the skin is usually not life-threatening, though it can be aggressive in some cases, and is normally treated with minor surgery.

Squamous cell carcinoma (SCC) of the lower extremity is a distinct subset of cutaneous squamous cell carcinomas which tend to occur multiply in elderly women. Histopathological studies of lower extremity SCCs reveals that they tend to be well differentiated and have low incidence of perineural and lymphovascular invasion and are also less prone to metastasis. Minor surgery has been the standard of care for this subset of SCC but leads to many complications such as poor wound healing and postoperative infections. Furthermore, a phenomenon called eruptive postoperative SCC can occur, in which cytokines released during wound healing triggering secondary tumor formation in genetically predisposed cells surrounding the original SCC. Given that lower extremity SCCs are less aggressive but more prone to surgical complications when excised, we believe they may be good candidates for localized non-surgical treatment.

5-fluorouracil (5FU) is a well-studied and characterized chemotherapeutic agent that has been used systemically, topically and intralesionally for a variety of malignancies and conditions including many dermatologic abnormalities.

It has been used on and off label topically for the treatment of actinic keratosis, SCC, superficial basal cell carcinoma, extra-mammary Paget's disease confined to the epidermis, Bowen's disease, porokeratosis, and genital warts. Intralesionally it has been used off label for the treatment of keloids, knuckle pads, warts, hypertrophic scars, basal cell carcinoma, and keratoanthoma.

Reports of its use intralesionally in invasive cutaneous SCC, other than in keratoacanthomas, are very limited. We are aware of 3 such reports in the literature. In the largest study to date, 6 weekly intralesional injections of 5FU-epinephrine gel were performed on 23 patients with cutaneous SCC on various body sites, 22 (96%) of whom demonstrated histologically confirmed tumor clearance. This study, however, used a proprietary gel formulation which is not widely available. There are two other case reports of successful treatment of SCC with 6-8 intralesional injections of 5FU at weekly intervals. The three published studies injected 0.6ml to 2.4ml of 5FU, per each weekly session, at concentrations of 30mg/ml to 50mg/ml.

Calcipotriene is a synthetic form of vitamin D. It is FDA approved for the treatment of psoriasis. Calcipotriene binds to vitamin D receptors on skin cells and helps regulate the growth and differentiation of skin cells. It inhibits keratinocyte proliferation (cell growth) and enhances keratinocyte differentiation. Recently it has been shown that calcipotriene acts as topical immune response modulator through induction of thymic stromal lymphoprotein (TSLP) expression. TSLP is an epithelium-derived cytokine and a regulator of allergic inflammation in the skin. It has been shown by Shadmehr Demehri et.al. that TSLP released by barrier-defective skin in mice blocks cancer development by recruiting T cells to mount robust antitumor immunity in the skin. The adaptive immune response mounted by TSLP against cancer can eliminate cancerous lesions in the skin and prevent new lesions from developing.

A recent clinical trial conducted by Demehri showed that participants treated with topical 5FU and topical and topical calcipotriene showed a significant reduction in the number of actinic keratosis (face, scalp, & upper extremities) vs topical 5FU and vaseline. Furthermore, the cohort treated with 5FU and topical and topical calcipotriene remained SCC-free for more than 1,500 days suggesting the induction of tissue-resident memory T (trm) cells.

The purpose of the study is to evaluate this relatively unexplored approach to the treatment of SCC on the lower extremities and establish a non-surgical therapy to improve outcomes, eliminate the need for surgery and mitigate the occurrence of infections and secondary tumor eruptions.

Topical 5FU is approved for the treatment of superficial basal cell carcinoma smaller than 2cm in diameter and not located on the feet, hands or feet but cannot penetrate deep enough into the skin to be an effective treatment for SCC. For the proposed phase I clinical trial, we propose to increase tumor accessibility by delivering 5FU directly and specifically to the tumor through intralesional injections to kill accessible localized SCC cells.

5FU is currently in clinical use with a well-established safety profile. It is anticipated that intralesional injections of 5FU will enable direct and specific delivery of chemotherapy to the tumor, thereby reducing the potential for systemic toxicity. Further, intralesional injections of-5FU enable tumoral delivery of locally effective concentrations of 5FU using doses that are orders of magnitude below those used currently for the intravenous (IV) treatment of multiple malignancies.

5FU alone may not be enough eliminate all the tumor cells so we also propose to treat a group of patients with intralesional 5FU and 0.005% calcipotriene topical cream. The goal is to develop a synergistic effect and establish an immune response to the 5FU induced apoptotic SCC cells in order to kill off any remaining SCC cells not undergoing apoptosis. Also 5FU alone may not be as effective of a treatment as the combination therapy in the prevention of secondary tumor recurrence. It is hoped that the combination therapy will induce a memory response and reduce the incidence of secondary tumors.

Participants will have at least 1 SCC lesion greater 1cm and less than 2 cm in largest diameter, on their lower extremities. The clinical diagnosis of SCC will be confirmed histologically by a deep shave biopsy of less than half of the lesion. The remainder of the lesion will be used for intralesional injections of 5FU or intralesional 5FU/topical calcipotriene according to the following schema:

In this study, a total of 30 patients will be randomly assigned into 3 groups. Randomization will be conducted using the UPCI randomizer, which is maintained by the Biostatistics Facility of UPCI (https://randomize.upci.pitt.edu/randomizer/home.seam). Group 1: 10 patients will serve as a control group, and will receive neither 5FU injection nor topical calcipotriene. Group 2: 10 patients, will receive a single intralesional injection of 50mg of 5FU in 1ml aqueous injectable solution once a month for 3 months. Group 3: 10 patients will receive intralesional 5FU as administered in the previous group. They will also apply a topical application of 0.005% calcipotriene cream to the same lesion two (2) times daily for four (4) days one (1) day after each of three (3) 5FU injections. At the time of initial consent, a 2 mm punch biopsy of the lesion will be obtained. Half of biopsy will be stored for tissue banking and future study, while the other half will be sent for histological confirmation of SCC. A second 2 mm punch biopsy will be taken at 2 months for mid-point analysis. This will be stored for tissue banking and future study. A month after the last injection (week 12), the lesion will be surgical resected in the non-treated Group 1 to render the participant's disease free. Resection is the current standard of care for these tumors. Participant's in Group 2 and 3 will have a 4mm punch biopsy will be taken to confirm pathologic resolution.

Depending on the results of the confirmational biopsy the following actions will be taken:

  1. Negative biopsy - clinical follow-up every 6 months for 2 years
  2. Positive biopsy - Mohs surgery 2-4 weeks after in In all groups part of, or all of, the resected tumor and surrounding skin will be stored for tissue banking and future study.

All lesions will be photographed and treatment response will be evaluated 4 weeks after the first 5FU injection prior to excision.

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.
30

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 1

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

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15238
        • Recruiting
        • St. Margaret Hospital Dermatology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Melissa Pugliano-Mauro, MD
        • Sub-Investigator:
          • Jeff Plowey, MS, MBA
        • Sub-Investigator:
          • Kevin Savage, MD
        • Sub-Investigator:
          • Hannah Glass, PA-C

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Biopsy-confirmed SCC more than 1.0 cm and less than 2.0 cm in diameter in the lower extremities, defined as the knees and below.
  • Subjects must have an expected survival of greater than or equal to12 months.
  • Subjects must not be on any other investigational device/drug treatment.
  • Subjects must to be willing to adhere to the instructions of the Investigator and his research team and sign an Informed Consent Form prior to entry into the study.
  • Patient is ≥ 18 years of age on day of signing informed consent.
  • Patient must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
  • Female patient of childbearing potential has a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the patient to be eligible.
  • Female patients enrolled in the study, who are not free from menses for > 2 years, post hysterectomy/oophorectomy, or surgically sterilized, must be willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy, or to abstain from heterosexual activity throughout the study, starting with the first dose of study drug at visit 1 through 120 days after the last dose of study drug. Approved contraceptive methods include for example: intra-uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, or female condom with spermicide. Spermicides alone are not an acceptable method of contraception. Male patients must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug.

Exclusion Criteria:

  • Patients with any evidence of nodal (Nx) and/or metastatic disease including distant subcutaneous and/or lymph node metastases.
  • Patients with primary non-cutaneous SCC - such as nasopharyngeal SCC.
  • Patient with history of receiving organ transplantation.
  • Patients with history of iatrogenic systemic immunosuppression.
  • Patients with a history of skin or other disorder(s),that in the opinion of the investigator, requires topical application of steroids and/or other creams/ointments.
  • Patients with evidence of active infection - active and/or untreated hepatitis B/C, HIV, etc - requiring systemic therapy.
  • Patients with a known history of autoimmune disease.

  • Patients with the following cardiac co-morbidities including:

    • Baseline known prolongation of QT/QTc interval (QTc interval >500 msec).
    • Heart failure either on clinical examination (manifestations include ascites, cardiomegaly, dyspnea, edema, gallop rhythm, hepatomegaly, oliguria, pleural effusion, pulmonary edema, tachycardia) or based on known decreased left ventricular ejection fraction (LV EF) <50%.
    • Patients who have had chemotherapy, radioactive or biological cancer therapy within four weeks prior to the first dose of study drug, or who has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the adverse effects (AEs) due to cancer therapeutics administered more than four weeks earlier. Subjects with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.
    • If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Patients currently participating or who have participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study drug.
  • Patients expected to require any other form of systemic or localized antineoplastic therapy while on study.

  • Patients with a known history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the patient has undergone potentially curative therapy with no evidence of that disease for five years.

    ° The time requirement also does not apply to patients who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cancers including cervical cancer, breast cancer, melanoma, or other in situ cancers.

  • Patients who have previously had a severe hypersensitivity reaction to 5-fluorouracil or imiquimod.
  • Serious illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia), bleeding disorders, autoimmune diseases, severe obstructive or restrictive pulmonary diseases, active systemic infections, and inflammatory bowel disorders.
  • Patients with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or are not in the best interest of the patient to participate, in the opinion of the treating Investigator.
  • Patients who are, at the time of signing informed consent, regularly using illicit drugs or are recently (within the last year) abusing illicit substances (including alcohol).
  • Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the 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.
No Intervention: Control Group
Control group will receive neither 5-fluorouracil (5FU) injection nor topical 0.005% calcipotriene cream. This group will receive standard of care only. Lesion will be surgical resected on day 84 of study.
Experimental: 5FU Group

5-fluorouracil (5FU) Group participants will receive a 1ml intralesional injection of 5FU 50mg/ml aqueous injectable solution. One injection will be administered once monthly for 3 month. Injections will occur on d0, d28, and d56. On the 4th visit the lesion site will be locally anesthetized and a 4mm punch biopsy will be taken to confirm pathologic resolution. Depending on the results of the confirmational biopsy the following actions will be taken:

  1. Negative biopsy - clinical follow-up every 6 months for 2 years
  2. Positive biopsy - Mohs surgery 2-4 weeks after
Drug: 5-fluorouracil
Intralesional injections of 50mg/ml over a 3 week period.
Other Names:
  • 5FU
  • Carac
  • Adrucil
  • Efudex
  • Fluoroplex
  • Tolak
  • PremierPro Rx Fluorouracil
  • Fluorouracil Novaplus
Experimental: 5FU + 0.005% Calcipotriene cream Group

5-fluorouracil (5FU) + 0.005% calcipotriene cream Group participants will receive intralesional 5FU as in the previous group, additionally participants will also receive two (2) times daily for four (4) days one (1) day after each of three (3) 5FU injections topical application of 0.005% calcipotriene cream to the same lesion. On the 4th visit the lesion site will be locally anesthetized and a 4mm punch biopsy will be taken to confirm pathologic resolution. Depending on the results of the confirmational biopsy the following actions will be taken:

  1. Negative biopsy - clinical follow-up every 6 months for 2 years
  2. Positive biopsy - Mohs surgery 2-4 weeks after
Drug: 5-fluorouracil
Intralesional injections of 50mg/ml over a 3 week period.
Other Names:
  • 5FU
  • Carac
  • Adrucil
  • Efudex
  • Fluoroplex
  • Tolak
  • PremierPro Rx Fluorouracil
  • Fluorouracil Novaplus
Drug: Calcipotriene
Topical application of .005% cream two (2) times daily for four (4) days one (1) day after each of three (3) 5FU injections..
Other Names:
  • Dovonex
  • Sorilux
  • Calcitrene
  • Calsodore
  • Kalosar

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
Determine number of subjects experiencing Dose Limiting Toxicity (DLT) higher than grade 2, as defined by CTCAE v. 4.0
Time Frame: 84 days

To assess Dose Limiting Toxicities (DLT) of intralesional-5FU and intralesional 5FU combined with topical imiquimod in subjects after 3 weeks of treatment.

Dose Limiting Toxicities (DLT) are defined as:

Higher-than grade 2 hematologic or non-hematologic toxicity that is definitely, probably, or possibly related to intralesional 5FU administration and/or topical imiquimod application. The NCI common terminology criteria for adverse events (CTCAE) version 4.0 will be used.

Based on the results of the previous studies on treating SCCs with 5FU injection or topical imiquimod, significant toxicities are not expected. Adverse reactions were limited to local site reactions such as treatment site pain, induration, erythema, edema.

If a patient has a DLT, doses will be delayed if any Grade >2 toxicities are not resolved to Grade 1 by the time of the next dose.
84 days

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
Asses clinical objective response rate
Time Frame: 84 days
Measure reduction in tumor burden to assess clinical objective response rate (ORR) in treated lesions. Response will be evaluated using modified Composite Assessment of Index Lesion Severity (CAILS) criteria by bi-dimensional measurement.
84 days

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.
Melissa Pugliano-Mauro

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

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.
  • Principal Investigator: Melissa Pugliano-Mauro, MD, University of Pittsburgh

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.

General Publications

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.
August 3, 2018

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.
September 30, 2027

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.
October 30, 2027

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).
December 1, 2017

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 11, 2017

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.
December 12, 2017

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.
June 1, 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.
May 27, 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.
May 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.
  • STUDY19090229
  • 5P50CA121973-10 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee (learned intermediary) identified for this purpose.

To achieve aims in the approved proposal.

Proposals may be submitted up to 36 months following article publication. Proposals should be directed to puglianomauroma@upmc.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years through RedCap.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • 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

product manufactured in and exported from the U.S.

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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