IncontinenceNCT06613503
Effectiveness of the AI-Supporter in Reducing Urinary Tract Infections
A study testing AI-supporter in people with Incontinence and Urinary Tract Infection, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The "AI Supporter," an intelligent excretion management robot, leverages artificial intelligence-based vision recognition to autonomously detect and cleanse affected areas, followed by drying and changing the diaper, thereby reducing caregiver strain and enhancing care quality. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Incontinence, Urinary Tract Infection, Incontinence-associated Dermatitis
- What is being tested?
- AI-supporter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Jul 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have been bedridden for at least 3 months and have urinary and/or fecal incontinence.
- Female participants aged over 20 years old.
- Participants must be capable of wearing the AI-supporter device during the study period.
Who cannot join
- Participants with severe skin conditions unrelated to incontinence.
- Participants with current urinary tract infections or incontinence-associated dermatitis at the time of enrollment.
- Participants who are unable to provide informed consent or have a legal representative to do so.
Trial locations and contacts
1 site in 1 country.
Jing-ya Fu contact
Taiwan1 site, 1 recruiting
- Recruiting
Rom A Master List, Extracted From This Organization'S Records.
Taichung
Kwo chen Lee, 886922351328, rubylee@mail.cmu.edu.tw
About this study
Official title: Testing the Effectiveness of the AI-Supporter in Reducing Urinary Tract Infections, Incontinence-associated Dermatitis and Caregiving Costs for Incontinence Patients
The "AI Supporter," an intelligent excretion management robot, leverages artificial intelligence-based vision recognition to autonomously detect and cleanse affected areas, followed by drying and changing the diaper, thereby reducing caregiver strain and enhancing care quality. This study aims to assess the efficacy of the "AI Supporter" in decreasing the incidence of urinary tract infections and incontinence-associated dermatitis among incontinent patients, in addition to exploring its cost-effectiveness.
Adopting an experimental (two groups) and longitudinal design, this research utilizes both convenience and random sampling strategies. The study anticipates recruiting 60 female subjects who have been confined to bed for more than three months with urinary and/or fecal incontinence. Participants will intermittently use the AI Supporter over a 14-day period. Measurement tools include routine urine analysis.
Read the detailed description
Background: As Taiwan progresses medically, the aging demographic has become a significant challenge, leading to an escalation in the disabled population. The lack of caregiving manpower represents a critical bottleneck in the provision of long-term care. Diaper changing, a daily and labor-intensive task for caregivers, involves bending motions that pose a risk of musculoskeletal injuries. Consequently, the imperative development of automated caregiving technologies has emerged. The "AI Supporter," an intelligent excretion management robot, leverages artificial intelligence-based vision recognition to autonomously detect and cleanse affected areas, followed by drying and changing the diaper, thereby reducing caregiver strain and enhancing care quality.
Objective: This study aims to assess the efficacy of the "AI Supporter" in decreasing the incidence of urinary tract infections and incontinence-associated dermatitis among incontinent patients, in addition to exploring its cost-effectiveness.
Methods: Adopting an experimental (two groups) and longitudinal design, this research utilizes both convenience and random sampling strategies. Scheduled from November 2024 to October 2025 at a residential long-term care facility in Central Taiwan, the study anticipates recruiting 60 female subjects who have been confined to bed for more than three months with urinary and/or fecal incontinence. Participants will intermittently use the AI Supporter over a 14-day period. Measurement tools include routine urine analysis, incontinence-associated dermatitis rating scales, pressure sore assessments, skin pH measurements, caregiver hours, and cost analyses pertaining to diapers and the AI Supporter. The principal analytical method employed will be Generalized Estimating Equations (GEE), with statistical significance defined at p < 0.05.
Expected Outcomes: The AI Supporter is expected to significantly reduce the occurrence of urinary tract infections and incontinance-associated dermatitis in patients, concurrently alleviating caregiver workload and diminishing associated costs.
- Conditions
- Incontinence, Urinary Tract Infection, Incontinence-associated Dermatitis, Cost-effectiveness
- Being tested
- AI-supporter
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-supporterDevice
Also called tradiational diapear
rticipants in the experimental group will use the AI-supporter, an intelligent excretion management robot. This device utilizes AI-driven visual recognition technology to automatically detect urine and feces, followed by a cleaning and drying process. When the AI-supporter detects excretion, it activates an automated sequence that washes, dries, and sanitizes the perineal area without requiring the caregiver to remove the diaper. The AI-supporter also records relevant data, such as the time, frequency, and weight of excretion, for further analysis. This intervention is designed to reduce the incidence of urinary tract infections (UTIs) and incontinence-associated dermatitis (IAD), as well as lessen the workload for caregivers
| Study group | Role | What they receive |
|---|---|---|
| AI-supporter | Experimental | Participants will use the AI-supporter for excretion detection, cleaning, and drying processes. Receives: Device: AI-supporter |
| Traditional Diapers | No intervention | Participants will use theTraditional Diapers for excretion detection, cleaning, and drying processes |
What is being measured
The primary outcome is the main question the study is designed to answer.
white blood cells
urine analysis
Measured: 14 days after intervention
Bacterial count
urine analysis
Measured: 14 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start22 Jul 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for IncontinenceStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description: In this clinical trial, a parallel design is employed, where participants are randomly assigned to one of two groups: an experimental group and a control group. The experimental group will use the AI-supporter for excretion detection, cleaning, and drying processes, while the control group will use traditional diapers for care. The two groups will not cross over during the trial, meaning participants will remain in their assigned group throughout the study. This design allows for a direct comparison of the intervention's efficacy, with each group receiving a distinct form of care. The primary objective is to assess the effectiveness of the AI-supporter in reducing urinary tract infections and incontinence-associated dermatitis
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kwo-Chen Lee, ph.D, Study director, 011+886+4+22053366#7102
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613503
- Sponsor's protocol ID
- CMUH113-REC3-109
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borchert K, Bliss DZ, Savik K, Radosevich DM. The incontinence-associated dermatitis and its severity instrument: development and validation. J Wound Ostomy Continence Nurs. 2010 Sep-Oct;37(5):527-35. doi: 10.1097/WON.0b013e3181edac3e.
PubMed 20736860Buckingham KW, Berg RW. Etiologic factors in diaper dermatitis: the role of feces. Pediatr Dermatol. 1986 Feb;3(2):107-12. doi: 10.1111/j.1525-1470.1986.tb00499.x.
PubMed 3513143Fader M, Clarke-O'Neill S, Cook D, Dean G, Brooks R, Cottenden A, Malone-Lee J. Management of night-time urinary incontinence in residential settings for older people: an investigation into the effects of different pad changing regimes on skin health. J Clin Nurs. 2003 May;12(3):374-86. doi: 10.1046/j.1365-2702.2003.00731.x.
PubMed 12709112Ferreira M, Abbade L, Bocchi SCM, Miot HA, Boas PV, Guimaraes HQCP. Incontinence-associated dermatitis in elderly patients: prevalence and risk factors. Rev Bras Enferm. 2020;73 Suppl 3:e20180475. doi: 10.1590/0034-7167-2018-0475. Epub 2020 Jul 13. English, Portuguese.
PubMed 32696899Francis K, Pang SM, Cohen B, Salter H, Homel P. Disposable Versus Reusable Absorbent Underpads for Prevention of Hospital-Acquired Incontinence-Associated Dermatitis and Pressure Injuries. J Wound Ostomy Continence Nurs. 2017 Jul/Aug;44(4):374-379. doi: 10.1097/WON.0000000000000337.
PubMed 28549048Gray M. Optimal management of incontinence-associated dermatitis in the elderly. Am J Clin Dermatol. 2010;11(3):201-10. doi: 10.2165/11311010-000000000-00000.
PubMed 20131923Hachem JP, Crumrine D, Fluhr J, Brown BE, Feingold KR, Elias PM. pH directly regulates epidermal permeability barrier homeostasis, and stratum corneum integrity/cohesion. J Invest Dermatol. 2003 Aug;121(2):345-53. doi: 10.1046/j.1523-1747.2003.12365.x.
PubMed 12880427Hahnel E, Blume-Peytavi U, Trojahn C, Kottner J. Associations between skin barrier characteristics, skin conditions and health of aged nursing home residents: a multi-center prevalence and correlational study. BMC Geriatr. 2017 Nov 13;17(1):263. doi: 10.1186/s12877-017-0655-5.
PubMed 29132305Kayser SA, Phipps L, VanGilder CA, Lachenbruch C. Examining Prevalence and Risk Factors of Incontinence-Associated Dermatitis Using the International Pressure Ulcer Prevalence Survey. J Wound Ostomy Continence Nurs. 2019 Jul/Aug;46(4):285-290. doi: 10.1097/WON.0000000000000548.
PubMed 31276451Minematsu T, Yamamoto Y, Nagase T, Naito A, Takehara K, Iizaka S, Komagata K, Huang L, Nakagami G, Akase T, Oe M, Yoshimura K, Ishizuka T, Sugama J, Sanada H. Aging enhances maceration-induced ultrastructural alteration of the epidermis and impairment of skin barrier function. J Dermatol Sci. 2011 Jun;62(3):160-8. doi: 10.1016/j.jdermsci.2011.03.005. Epub 2011 Mar 23.
PubMed 21498052Mugita Y, Koudounas S, Nakagami G, Weller C, Sanada H. Assessing absorbent products' effectiveness for the prevention and management of incontinence-associated dermatitis caused by urinary, faecal or double adult incontinence: A systematic review. J Tissue Viability. 2021 Nov;30(4):599-607. doi: 10.1016/j.jtv.2021.07.002. Epub 2021 Jul 13.
PubMed 34376333Musa MK, Saga S, Blekken LE, Harris R, Goodman C, Norton C. The Prevalence, Incidence, and Correlates of Fecal Incontinence Among Older People Residing in Care Homes: A Systematic Review. J Am Med Dir Assoc. 2019 Aug;20(8):956-962.e8. doi: 10.1016/j.jamda.2019.03.033. Epub 2019 May 23.
PubMed 31129021Nix DH. Validity and reliability of the Perineal Assessment Tool. Ostomy Wound Manage. 2002 Feb;48(2):43-6, 48-9.
PubMed 15382413Shin YS, Kim HJ, Moon NK, Ahn YH, Kim KO. The effects of uncoated paper on skin moisture and transepidermal water loss in bedridden patients. J Clin Nurs. 2012 Sep;21(17-18):2469-76. doi: 10.1111/j.1365-2702.2012.04160.x.
PubMed 22889444Sugama J, Sanada H, Shigeta Y, Nakagami G, Konya C. Efficacy of an improved absorbent pad on incontinence-associated dermatitis in older women: cluster randomized controlled trial. BMC Geriatr. 2012 May 29;12:22. doi: 10.1186/1471-2318-12-22.
PubMed 22642800
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of the AI-Supporter in Reducing Urinary Tract Infections, Incontinence-associated Dermatitis and Caregiving Costs for Incontinence Patients
- ClinicalTrials.gov ID
- NCT06613503
- Acronym / sponsor ID
- CMUH113-REC3-109
- Conditions
- Incontinence, Urinary Tract Infection, Incontinence-associated Dermatitis, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The "AI Supporter," an intelligent excretion management robot, leverages artificial intelligence-based vision recognition to autonomously detect and cleanse affected areas, followed by drying and changing the diaper, thereby reducing caregiver strain and enhancing care quality. This study aims to assess the efficacy of the "AI Supporter" in decreasing the incidence of urinary tract infections and incontinence-associated dermatitis among incontinent patients, in addition to exploring its cost-effectiveness.
Adopting an experimental (two groups) and longitudinal design, this research utilizes both convenience and random sampling strategies. The study anticipates recruiting 60 female subjects who have been confined to bed for more than three months with urinary and/or fecal incontinence. Participants will intermittently use the AI Supporter over a 14-day period. Measurement tools include routine urine analysis.
Detailed description
Background: As Taiwan progresses medically, the aging demographic has become a significant challenge, leading to an escalation in the disabled population. The lack of caregiving manpower represents a critical bottleneck in the provision of long-term care. Diaper changing, a daily and labor-intensive task for caregivers, involves bending motions that pose a risk of musculoskeletal injuries. Consequently, the imperative development of automated caregiving technologies has emerged. The "AI Supporter," an intelligent excretion management robot, leverages artificial intelligence-based vision recognition to autonomously detect and cleanse affected areas, followed by drying and changing the diaper, thereby reducing caregiver strain and enhancing care quality.
Objective: This study aims to assess the efficacy of the "AI Supporter" in decreasing the incidence of urinary tract infections and incontinence-associated dermatitis among incontinent patients, in addition to exploring its cost-effectiveness.
Methods: Adopting an experimental (two groups) and longitudinal design, this research utilizes both convenience and random sampling strategies. Scheduled from November 2024 to October 2025 at a residential long-term care facility in Central Taiwan, the study anticipates recruiting 60 female subjects who have been confined to bed for more than three months with urinary and/or fecal incontinence. Participants will intermittently use the AI Supporter over a 14-day period. Measurement tools include routine urine analysis, incontinence-associated dermatitis rating scales, pressure sore assessments, skin pH measurements, caregiver hours, and cost analyses pertaining to diapers and the AI Supporter. The principal analytical method employed will be Generalized Estimating Equations (GEE), with statistical significance defined at p < 0.05.
Expected Outcomes: The AI Supporter is expected to significantly reduce the occurrence of urinary tract infections and incontinance-associated dermatitis in patients, concurrently alleviating caregiver workload and diminishing associated costs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Model Description: In this clinical trial, a parallel design is employed, where participants are randomly assigned to one of two groups: an experimental group and a control group. The experimental group will use the AI-supporter for excretion detection, cleaning, and drying processes, while the control group will use traditional diapers for care. The two groups will not cross over during the trial, meaning participants will remain in their assigned group throughout the study. This design allows for a direct comparison of the intervention's efficacy, with each group receiving a distinct form of care. The primary objective is to assess the effectiveness of the AI-supporter in reducing urinary tract infections and incontinence-associated dermatitis
| Arm | Type | Receives |
|---|---|---|
| AI-supporter | Experimental | Device: AI-supporterParticipants will use the AI-supporter for excretion detection, cleaning, and drying processes. |
| Traditional Diapers | No intervention | –Participants will use theTraditional Diapers for excretion detection, cleaning, and drying processes |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must have been bedridden for at least 3 months and have urinary and/or fecal incontinence.
- Female participants aged over 20 years old.
- Participants must be capable of wearing the AI-supporter device during the study period.
Key exclusion criteria (3 listed)
- Participants with severe skin conditions unrelated to incontinence.
- Participants with current urinary tract infections or incontinence-associated dermatitis at the time of enrollment.
- Participants who are unable to provide informed consent or have a legal representative to do so.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-supporterAlso: tradiational diapearrticipants in the experimental group will use the AI-supporter, an intelligent excretion management robot. This device utilizes AI-driven visual recognition technology to automatically detect urine and feces, followed by a cleaning and drying process. When the AI-supporter detects excretion, it activates an automated sequence that washes, dries, and sanitizes the perineal area without requiring the caregiver to remove the diaper. The AI-supporter also records relevant data, such as the time, frequency, and weight of excretion, for further analysis. This intervention is designed to reduce the incidence of urinary tract infections (UTIs) and incontinence-associated dermatitis (IAD), as well as lessen the workload for caregivers | Device | AI-supporter |
Primary outcome
white blood cells
Time frame: 14 days after intervention
urine analysis
Bacterial count
Time frame: 14 days after intervention
urine analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Background: PubMed 20736860Borchert K, Bliss DZ, Savik K, Radosevich DM. The incontinence-associated dermatitis and its severity instrument: development and validation. J Wound Ostomy Continence Nurs. 2010 Sep-Oct;37(5):527-35. doi: 10.1097/WON.0b013e3181edac3e.
- Background: PubMed 3513143Buckingham KW, Berg RW. Etiologic factors in diaper dermatitis: the role of feces. Pediatr Dermatol. 1986 Feb;3(2):107-12. doi: 10.1111/j.1525-1470.1986.tb00499.x.
- Background: PubMed 12709112Fader M, Clarke-O'Neill S, Cook D, Dean G, Brooks R, Cottenden A, Malone-Lee J. Management of night-time urinary incontinence in residential settings for older people: an investigation into the effects of different pad changing regimes on skin health. J Clin Nurs. 2003 May;12(3):374-86. doi: 10.1046/j.1365-2702.2003.00731.x.
- Background: PubMed 32696899Ferreira M, Abbade L, Bocchi SCM, Miot HA, Boas PV, Guimaraes HQCP. Incontinence-associated dermatitis in elderly patients: prevalence and risk factors. Rev Bras Enferm. 2020;73 Suppl 3:e20180475. doi: 10.1590/0034-7167-2018-0475. Epub 2020 Jul 13. English, Portuguese.
- Background: PubMed 28549048Francis K, Pang SM, Cohen B, Salter H, Homel P. Disposable Versus Reusable Absorbent Underpads for Prevention of Hospital-Acquired Incontinence-Associated Dermatitis and Pressure Injuries. J Wound Ostomy Continence Nurs. 2017 Jul/Aug;44(4):374-379. doi: 10.1097/WON.0000000000000337.
- Background: PubMed 20131923Gray M. Optimal management of incontinence-associated dermatitis in the elderly. Am J Clin Dermatol. 2010;11(3):201-10. doi: 10.2165/11311010-000000000-00000.
- Background: PubMed 12880427Hachem JP, Crumrine D, Fluhr J, Brown BE, Feingold KR, Elias PM. pH directly regulates epidermal permeability barrier homeostasis, and stratum corneum integrity/cohesion. J Invest Dermatol. 2003 Aug;121(2):345-53. doi: 10.1046/j.1523-1747.2003.12365.x.
- Background: PubMed 29132305Hahnel E, Blume-Peytavi U, Trojahn C, Kottner J. Associations between skin barrier characteristics, skin conditions and health of aged nursing home residents: a multi-center prevalence and correlational study. BMC Geriatr. 2017 Nov 13;17(1):263. doi: 10.1186/s12877-017-0655-5.
- Background: PubMed 31276451Kayser SA, Phipps L, VanGilder CA, Lachenbruch C. Examining Prevalence and Risk Factors of Incontinence-Associated Dermatitis Using the International Pressure Ulcer Prevalence Survey. J Wound Ostomy Continence Nurs. 2019 Jul/Aug;46(4):285-290. doi: 10.1097/WON.0000000000000548.
- Background: PubMed 21498052Minematsu T, Yamamoto Y, Nagase T, Naito A, Takehara K, Iizaka S, Komagata K, Huang L, Nakagami G, Akase T, Oe M, Yoshimura K, Ishizuka T, Sugama J, Sanada H. Aging enhances maceration-induced ultrastructural alteration of the epidermis and impairment of skin barrier function. J Dermatol Sci. 2011 Jun;62(3):160-8. doi: 10.1016/j.jdermsci.2011.03.005. Epub 2011 Mar 23.
- Background: PubMed 34376333Mugita Y, Koudounas S, Nakagami G, Weller C, Sanada H. Assessing absorbent products' effectiveness for the prevention and management of incontinence-associated dermatitis caused by urinary, faecal or double adult incontinence: A systematic review. J Tissue Viability. 2021 Nov;30(4):599-607. doi: 10.1016/j.jtv.2021.07.002. Epub 2021 Jul 13.
- Background: PubMed 31129021Musa MK, Saga S, Blekken LE, Harris R, Goodman C, Norton C. The Prevalence, Incidence, and Correlates of Fecal Incontinence Among Older People Residing in Care Homes: A Systematic Review. J Am Med Dir Assoc. 2019 Aug;20(8):956-962.e8. doi: 10.1016/j.jamda.2019.03.033. Epub 2019 May 23.
- The Impact of an Absorbent Underpad on the Prevention and/or Improvement of Incontinence Associated Dermatitis in Skilled Nursing Facility (SNF) Residents.Link provided by the sponsor.
- IAD made easy.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing-ya Fu contact
Kwo-Chen Lee, ph.D study director
011+886+4+22053366#7102
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-supporter in people with Incontinence and Urinary Tract Infection, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kwo-Chen Lee, ph.D (886422053366 ext. 7102, rubylee@mail.cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
white blood cells (time frame: 14 days after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06613503, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.