ClinicalTrials.gg
RecruitingNCT07733973CCC-CancerUpdated Nov 10, 2026

Effectiveness, Acceptability and Feasibility of a Communication and Care Coordinator (CCC) Model in Facilitating Serious Illness Communication (SIC) and Care in Patients With Cancer

An interventional study of CCC Intervention in Cancer, sponsored by National Cancer Centre, Singapore. Recruiting at 1 site in Singapore. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by National Cancer Centre, Singapore · Not applicable, Interventional, and Health services research

Updated Nov 10, 2026Now RecruitingSite recruiting status changed+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
560
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to evaluate the communication and care coordinator (CCC) model in a national cancer institute and assess the utility of the model in facilitating serious illness communication (SIC) and care for patients with cancer.

The study aims are:

  • To assess the effectiveness of the CCC model in improving patient outcomes.
  • To assess the effectiveness of the CCC model in increasing rates of SIC and advance care planning (ACP) record documentation.
  • To assess the acceptability of the CCC model to patients and clinicians.
  • To evaluate the feasibility of implementing a CCC model in oncology care.

Researchers will compare results from the CCC intervention arm and usual care arm, to see if the CCC model can help improve patient outcomes and facilitate SIC between patients and clinicians.

Patient participants will:

  • Follow the assignment of their clinician, who will be assigned randomly to either the usual care group or the intervention group.
  • Be assigned a CCC and receive 6 CCC sessions over the course of 3 months (if assigned to CCC intervention arm).
  • Complete 3 study assessment visits at baseline, Week 6, and 3 months
  • Be invited to a one-time interview to share their study experience (optional, if selected and if in CCC intervention arm).
Read the detailed description

Timely SIC may facilitate earlier preferred plan of care documentation and improve patients' sense of peacefulness, hopefulness, and connectedness with their clinicians. The primary goal of the study is to evaluate the CCC model in a national cancer institute and assess the utility of the model in facilitating SIC and care for patients with cancer through a stepped wedge cluster randomized trial. This approach delivers crucial, empirical insights into how SIC can be efficiently and effectively delivered and potentially allow larger scale implementation and dissemination of the CCC model in Singapore, as an effective model for delivering patient support and facilitating patient-clinician communication in patients with advanced cancer.

02

Conditions studied

  • Cancer

Keywords

  • Communication and Care Coordinators
  • Serious Illness Communication
  • Healthcare Communication
  • Cancer Care
  • Oncology
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 560 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

National Cancer Centre, Singapore is the lead sponsor of 117 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 10, 2026. See what changed

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patient Participants

  • Aged 21 and above
  • Diagnosed with (a) advanced cancer (stage 3 or 4) or (b) non-advanced cancer, but at high risk of recurrence
  • Able to speak English or Chinese, irrespective of race

Clinicians

  • Oncologists who are at least of designation of associate consultant and above in NCCS

Exclusion criteria

Exclusion Criteria:

Patient Participants

  • Disoriented and thus not able to sign
  • Diagnosed with untreated hearing or visual loss or psychiatric illness
  • Active suicidal ideation

Clinicians

  • Overseas/not practising in Singapore for a significant amount of time
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
560 participants (estimated)

Study arms

  • Experimental
    CCC Intervention Arm

    Each participant will be assigned a CCC and receive 6 CCC sessions over the course of 3 months.

    Other: CCC Intervention

  • No intervention
    Usual Care Arm

    Each participant will continue to be followed by the oncologist and receive usual care but will not receive CCC intervention.

Interventions

  • OtherCCC Intervention

    CCC sessions will be on exploring participant's illness journey thus far, their concerns, values and priorities.

06

What researchers measure

Primary outcomes

  1. Communication Quality

    Feeling Heard and Understood Survey (FHU) is a validated 4-item scale that has been used in palliative care to measure effectiveness of the SIC conversations and the value of the therapeutic relationship between the care team and the patient. The lowest possible score is 0 and the highest possible score is 16, with a higher score indicating that the care team listens well, respects patient's needs, and provides clear communication.

    Time frame: Baseline, Week 6 after Baseline, and 3 months Post Enrolment.

  2. Quality of Life per FACT-G7

    Functional Assessment of Cancer Therapy-General-7 Item version (FACT-G7) is a 7-item questionnaire designed to quickly and effectively capture the most relevant issues to cancer. FACT-G7 scores could potentially range from 0-28, with a higher score indicating a better quality of life.

    Time frame: Baseline, Week 6 after Baseline, and 3 months Post Enrolment.

  3. Health Utility

    EuroQOL Group 5-Dimension (EQ-5D-5L) contains a 5-item descriptive system measuring 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression; a visual analogue scale (VAS) measuring overall health status. EQ-5D Index Value (Utility Score) ranges from 0 to 1.0 with higher value indicating better health-related quality of life. The VAS ranges from 0 to 100, with higher scores reflecting better self-rated health.

    Time frame: Baseline, Week 6 after Baseline, and 3 months Post Enrolment.

  4. Spiritual Well-Being

    Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) is a validated 12-item survey that is commonly used in the palliative care setting. It has 3 subscales (meaning, peace and faith). Scores in each subscale can potentially range from 0-16 and the total scores can range from 0-48. A higher score indicates greater spiritual well-being, better ability to find purpose in life and drawing comfort from spiritual resources.

    Time frame: Baseline, Week 6 after Baseline, and 3 months Post Enrolment.

  5. Healthcare Utilization - Rate of Unplanned Acute Hospital Utilization

    The rate of unplanned acute hospital utilization through the emergency department during the study will be collected.

    Time frame: From Study Enrolment to 3 months Post Enrolment.

  6. Healthcare utilization - Length of hospital stay

    Data on the length of stay in hospital (bed days) will be collected.

    Time frame: From Study Enrolment until Date of Death, up to 3 years.

  7. Healthcare utilization - Hospital Bill

    Data on hospital bill size will be collected.

    Time frame: From Study Enrolment until Date of Death, up to 3 years.

  8. Healthcare utilization - Type of oncological treatment

    Data on the type of oncological treatment used will be collected.

    Time frame: From 3 months prior to study enrolment until 3 months after study enrolment.

  9. Healthcare utilization - Chemotherapy usage (line)

    Data on the line of chemotherapy (first, second or third or subsequent (fourth and onwards)) will be collected.

    Time frame: From Study Enrolment until Date of Death, up to 3 years.

  10. Healthcare utilization - Intensive care unit visit

    Data on the number of intensive care unit visits will be collected.

    Time frame: From Study Enrolment until Date of Death, up to 3 years.

  11. Healthcare utilization - Length of intensive care unit visit

    Data on the length of intensive care unit visits will be collected.

    Time frame: From Study Enrolment until Date of Death, up to 3 years.

  12. Healthcare utilization - High dependency unit visit

    Data on the number of high dependency unit visits will be collected.

    Time frame: From Study Enrolment until Date of Death, up to 3 years.

  13. Healthcare utilization - Length of high dependency unit visit

    Data on the length of high dependency unit visits will be collected.

    Time frame: From Study Enrolment until Date of Death, up to 3 years.

  14. Healthcare utilization - Location of death

    Data on the location of death will be collected.

    Time frame: From Study Enrolment until Date of Death, up to 3 years.

Secondary outcomes

  1. Acceptability - Satisfaction

    Client satisfaction survey is a 4-item, 4-point scale survey in which patients provide ratings on their satisfaction with the intervention, and their views on its relevance, timeliness, and impact. It has been validated in research studies in the outpatient setting around mental health support. Score can range from 4-16, with a higher score indicating greater client satisfaction.

    Time frame: 3 months Post Enrolment.

  2. Feasibility - Approach-to-Enrolment Rates

    Approach-to-enrolment rates - where feasibility is defined that at least 60% of those patients approached could be enrolled into the study.

    Time frame: From Commencement of Study Recruitment till the End of Recruitment, up to 24 months.

  3. Feasibility - Patient Retention Rate

    Patient retention rate - where feasibility is defined that at least 80% of enrolled patients will be able to participate in the study for the planned study duration (3 months).

    Time frame: Baseline through Study Completion, estimated as up to 3 years.

  4. Effectiveness - SIC and ACP documentation

    The number of SIC and ACP documentation per clinician per enrolled patient during the study duration will be tracked during the intervention period(s) and during the control period(s). Clinical notes will also be read to evaluate if there was relevant documentation by clinician on SIC related issues.

    Time frame: From Commencement of Study Enrollment through Study Completion, estimated as up to 3 years

  5. Effectiveness - Time spent

    Time spent by CCC in this model and estimated time spent by clinicians on SICs will be collected.

    Time frame: From Commencement of Study Enrollment through Study Completion, estimated as up to 3 years

  6. Acceptability - Clinician experience

    Clinicians will be surveyed using a modified version of the Clinician Experience Survey (CES). The original CES was developed by Ariadne Labs for the purposes of assessing clinicians perceived feasibility and barriers in engaging patients in SIC. The researchers will modify the CES to form a 4-item scale (score range 4-16), with a higher score indicating greater clinicians' satisfaction with the CCC intervention.

    Time frame: At end of intervention period (28th month).

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Bernacki RE, Block SD; American College of Physicians High Value Care Task Force. Communication about serious illness care goals: a review and synthesis of best practices. JAMA Intern Med. 2014 Dec;174(12):1994-2003. doi: 10.1001/jamainternmed.2014.5271. PubMed 25330167 ↗
  • Nikbakhsh N, Moudi S, Abbasian S, Khafri S. Prevalence of depression and anxiety among cancer patients. Caspian J Intern Med. 2014 Summer;5(3):167-70. PubMed 25202445 ↗
  • Kumar P, Wixon-Genack J, Kavanagh J, Sanders JJ, Paladino J, O'Connor NR. Serious Illness Conversations With Outpatient Oncology Clinicians: Understanding the Patient Experience. JCO Oncol Pract. 2020 Dec;16(12):e1507-e1515. doi: 10.1200/JOP.19.00765. Epub 2020 Aug 4. PubMed 32749931 ↗
  • Geerse OP, Lamas DJ, Sanders JJ, Paladino J, Kavanagh J, Henrich NJ, Berendsen AJ, Hiltermann TJN, Fromme EK, Bernacki RE, Block SD. A Qualitative Study of Serious Illness Conversations in Patients with Advanced Cancer. J Palliat Med. 2019 Jul;22(7):773-781. doi: 10.1089/jpm.2018.0487. Epub 2019 Feb 6. PubMed 30724693 ↗
  • Paladino J, Koritsanszky L, Nisotel L, Neville BA, Miller K, Sanders J, Benjamin E, Fromme E, Block S, Bernacki R. Patient and clinician experience of a serious illness conversation guide in oncology: A descriptive analysis. Cancer Med. 2020 Jul;9(13):4550-4560. doi: 10.1002/cam4.3102. Epub 2020 May 4. PubMed 32363775 ↗
  • Baxter R, Fromme EK, Sandgren A. Patient Identification for Serious Illness Conversations: A Scoping Review. Int J Environ Res Public Health. 2022 Mar 31;19(7):4162. doi: 10.3390/ijerph19074162. PubMed 35409844 ↗
  • Sudore RL, Fried TR. Redefining the "planning" in advance care planning: preparing for end-of-life decision making. Ann Intern Med. 2010 Aug 17;153(4):256-61. doi: 10.7326/0003-4819-153-4-201008170-00008. PubMed 20713793 ↗
  • Agency for integrated care. Advance care planning. Accessed via: aic.sg/Care-Services/Advance-Care-Planning-ACP. Last accessed on February 6th 2026.
  • Epstein AS, Riley M, Nelson JE, Bernal C, Martin S, Xiao H. Goals of care documentation by medical oncologists and oncology patient end-of-life care outcomes. Cancer. 2022 Sep 15;128(18):3400-3407. doi: 10.1002/cncr.34400. Epub 2022 Jul 22. PubMed 35866716 ↗
  • Karim S, Levine O, Simon J. The Serious Illness Care Program in Oncology: Evidence, Real-World Implementation and Ongoing Barriers. Curr Oncol. 2022 Mar 2;29(3):1527-1536. doi: 10.3390/curroncol29030128. PubMed 35323328 ↗
  • Malhotra C, Chaudhry I. Barriers to advance care planning among patients with advanced serious illnesses: A national survey of health-care professionals in Singapore. Palliat Support Care. 2024 Oct;22(5):978-985. doi: 10.1017/S1478951523000214. PubMed 37005352 ↗
  • Ahluwalia SC, Levin JR, Lorenz KA, Gordon HS. Missed opportunities for advance care planning communication during outpatient clinic visits. J Gen Intern Med. 2012 Apr;27(4):445-51. doi: 10.1007/s11606-011-1917-0. Epub 2011 Oct 25. PubMed 22038469 ↗
  • Shilling DM, Manz CR, Strand JJ, Patel MI. Let Us Have the Conversation: Serious Illness Communication in Oncology: Definitions, Barriers, and Successful Approaches. Am Soc Clin Oncol Educ Book. 2024 Jun;44(3):e431352. doi: 10.1200/EDBK_431352. PubMed 38788187 ↗
  • Nagelschmidt K, Leppin N, Seifart C, Rief W, von Blanckenburg P. Systematic mixed-method review of barriers to end-of-life communication in the family context. BMJ Support Palliat Care. 2021 Sep;11(3):253-263. doi: 10.1136/bmjspcare-2020-002219. Epub 2020 Aug 27. PubMed 32855230 ↗
  • Hanley S, Cotner CE, Fenton A, Wright AA, Manz CR. Barriers to Serious Illness Conversations Among Patients with Advanced Cancer: A Qualitative Study. J Pain Symptom Manage. 2025 Feb;69(2):183-189.e4. doi: 10.1016/j.jpainsymman.2024.10.034. Epub 2024 Nov 7. PubMed 39515596 ↗
  • Martina D, Geerse OP, Lin CP, Kristanti MS, Bramer WM, Mori M, Korfage IJ, van der Heide A, Rietjens JA, van der Rijt CC. Asian patients' perspectives on advance care planning: A mixed-method systematic review and conceptual framework. Palliat Med. 2021 Dec;35(10):1776-1792. doi: 10.1177/02692163211042530. Epub 2021 Sep 6. PubMed 34488509 ↗
  • Patel MI, Periyakoil VS, Blayney DW, Moore D, Nevedal A, Asch S, Milstein A, Coker TR. Redesigning Cancer Care Delivery: Views From Patients and Caregivers. J Oncol Pract. 2017 Apr;13(4):e291-e302. doi: 10.1200/JOP.2016.017327. Epub 2017 Feb 7. PubMed 28399387 ↗
  • Patel MI, Kapphahn K, Dewland M, Aguilar V, Sanchez B, Sisay E, Murillo A, Smith K, Park DJ. Effect of a Community Health Worker Intervention on Acute Care Use, Advance Care Planning, and Patient-Reported Outcomes Among Adults With Advanced Stages of Cancer: A Randomized Clinical Trial. JAMA Oncol. 2022 Aug 1;8(8):1139-1148. doi: 10.1001/jamaoncol.2022.1997. PubMed 35771552 ↗
  • Patel MI, Ramirez D, Agajanian R, Agajanian H, Coker T. Association of a Lay Health Worker Intervention With Symptom Burden, Survival, Health Care Use, and Total Costs Among Medicare Enrollees With Cancer. JAMA Netw Open. 2020 Mar 2;3(3):e201023. doi: 10.1001/jamanetworkopen.2020.1023. PubMed 32176306 ↗
  • Lee ASY, Tang SN, Phua GLG, Yee AC, Neo SH. Adaptation of the Serious Illness Conversation Guide to Singapore's Multicultural Setting for Patients With Heart Failure, Renal Failure, or Cancer. Palliat Med Rep. 2024 Mar 26;5(1):122-126. doi: 10.1089/pmr.2023.0086. eCollection 2024. PubMed 38560744 ↗
  • Ramakrishnan C, Lee ASY, Malhotra C, Phua GLG, Yee A, Neo SH. Adaptation of the serious illness conversation guide to a multicultural context in Singapore: a qualitative study. BMJ Open. 2025 Oct 23;15(10):e098264. doi: 10.1136/bmjopen-2024-098264. PubMed 41146382 ↗
  • Ng A, Phua GL, Neo HS. Iterative adaptation and acceptability testing of the serious illness conversation guide for use with mandarin-speaking patients. Pal Med Rep. 2025 Nov;11(1):564-573.
  • Ng A, Sivasamy V, Neo SHS. Cultural adaptation of the serious illness conversation guide for caregivers of persons with dementia in Singapore. BMC Geriatr. 2025 Dec 30;25(1):1075. doi: 10.1186/s12877-025-06761-4. PubMed 41469578 ↗
  • Ng A, Yeo SM, Neo SH. Patient Readiness for Serious Illness Conversations: Identifying Psycho-Emotional Barriers Through a Phenomenological Lens. Psychooncology. 2025 Nov;34(11):e70317. doi: 10.1002/pon.70317. PubMed 41148236 ↗
  • Gov.sg. Scribe. Accessed via: https://reports.open.gov.sg/scribe/overview Last accessed on February 9th, 2026.
  • Chan HY, Leung DY, Lam PT, Ko PP, Lam RW, Chan KS. Effect of motivational interviewing to promote advance care planning among palliative care patients in ambulatory care setting: a randomized controlled trial. BMC Palliat Care. 2025 Jan 31;24(1):31. doi: 10.1186/s12904-025-01667-9. PubMed 39891169 ↗
  • Edelen MO, Rodriguez A, Huang W, Gramling R, Ahluwalia SC. A novel Scale to Assess Palliative Care Patients' Experience of Feeling Heard and Understood. J Pain Symptom Manage. 2022 May;63(5):689-697.e1. doi: 10.1016/j.jpainsymman.2022.01.002. Epub 2022 Jan 10. PubMed 35017018 ↗
  • Bandini JI, Schulson LB, Messan Setodji C, Williams J, Ast K, Ahluwalia SC. "Palliative Care Is the Only Medical Field That I Feel Like I'm Treated As a Person, Not As a Black Person": A Mixed-Methods Study of Minoritized Patient Experiences with Palliative Care. J Palliat Med. 2023 Feb;26(2):220-227. doi: 10.1089/jpm.2022.0237. Epub 2022 Aug 16. PubMed 35969381 ↗
  • FACIT.org. Functional assessment of cancer therapy-general-7 item version. Accessed via: facit.org/measures/fact-g7. Last accessed on February 8th, 2026.
  • EUROQOL. EQ-5D-5L. Accessed via: euroqol.org/information-and-support/euroqol-instruments-eq-5d-5l/. Last accessed on February 8th, 2026.
  • FACIT.org. Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-Sp-12). Last accessed via: https://www.facit.org/measures/facit-sp-12 Accessed on February 8th, 2026.
  • CSQ scales. CSQ-4. Accessed via: https://csqscales.com/product/csq-04/ Last accessed on February 8th, 2026.
  • Pedersen H, Skliarova T, Attkisson CC, Lara-Cabrera ML, Havnen A. Measuring patient satisfaction with four items: validity of the client satisfaction questionnaire 4 in an outpatient population. BMC Psychiatry. 2023 Nov 7;23(1):808. doi: 10.1186/s12888-023-05310-w. PubMed 37936112 ↗
  • Ariadne Labs. ARIA. Accessed via: https://www.ariadnelabs.org/aria/ Last accessed February 2nd, 2026.
  • Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42. PubMed 21513547 ↗
  • Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812. PubMed 22310560 ↗
  • Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101. doi.org/10.1191/1478088706qp063oa

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Nov 10, 2026
Sites
National Cancer Center, Singapore is now Recruiting
Nov 10, 2026
Start date
Aug 1, 2026→Nov 5, 2026 (actual)
Nov 10, 2026
Eligibility
1 exclusion criterion edited, 1 added
What changed in the criteria
Exclusion criteria
  • EditedConfused/Disoriented and thus not able to sign informed consent
  • AddedActive suicidal ideation
Nov 10, 2026
Primary outcomes
1 edited, 2 added
What changed in the outcomes
  • EditedHealthcare utilization - Chemotherapy usage (type)Type of oncological treatmentTime frame: From Study Enrolment until Date of Death, up to 3 years. → From 3 months prior to study enrolment until 3 months after study enrolment.
  • AddedHealthcare utilization - High dependency unit visitTime frame: From Study Enrolment until Date of Death, up to 3 years.
  • AddedHealthcare utilization - Length of high dependency unit visitTime frame: From Study Enrolment until Date of Death, up to 3 years.
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Not yet recruiting→Recruiting
    National Cancer Center, Singapore is now Recruiting
    Start date Aug 1, 2026→Nov 5, 2026 (now actual)
    Eligibility 1 exclusion criterion edited, 1 added
    What changed in the criteria
    Exclusion criteria
    • EditedConfused/Disoriented and thus not able to sign informed consent
    • AddedActive suicidal ideation
    Primary outcomes 1 edited, 2 added
    What changed in the outcomes
    • EditedHealthcare utilization - Chemotherapy usage (type)Type of oncological treatmentTime frame: From Study Enrolment until Date of Death, up to 3 years. → From 3 months prior to study enrolment until 3 months after study enrolment.
    • AddedHealthcare utilization - High dependency unit visitTime frame: From Study Enrolment until Date of Death, up to 3 years.
    • AddedHealthcare utilization - Length of high dependency unit visitTime frame: From Study Enrolment until Date of Death, up to 3 years.
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07733973
Responsible party
Sponsor
First posted
Jul 29, 2026
Start date
Nov 5, 2026
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Nov 10, 2026

Study contacts

Shirlyn NEO Hui Shan, MD, PhD
Contact
shirlyn.neo.h.s@singhealth.com.sg
63065838
Benton PT TAM, MSc
Contact
Shirlyn NEO Hui Shan, MD, PhD
study chair · National Cancer Centre, Singapore

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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