Intracranial Lymphatic Circulation DisorderCLVA-CLNA-ICLCNCT07328386
Effect of Cervical Lymphaticovenous and Lymph Node-to-Vein Anastomosis in Patients With Intracranial Lymphatic Circulation Disorder
A study testing Cervical Lymphaticovenous and Lymph Node-to-Vein Anastomosis in people with Intracranial Lymphatic Circulation Disorder and Alzheimer's Disease, run by Hong Joonpio at 1 site in South Korea.
Trial summary
This study is a single-center, prospective clinical trial designed to evaluate the therapeutic effects of lymphaticovenular anastomosis (LVA) and lymph node-venous anastomosis (LNVA) in patients with intracranial lymphatic circulation disorders. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Intracranial Lymphatic Circulation Disorder, Alzheimer's Disease
- What is being tested?
- Cervical Lymphaticovenous and Lymph Node-to-Vein Anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Feb 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 19 years or older who are diagnosed with intracranial lymphatic circulation disorder based on neurological evaluation.
- Global Deterioration Scale (GDS) score between 3 and 5 at screening.
- Diagnosis of Alzheimer's disease confirmed by amyloid PET-CT or CSF amyloid testing, showing amyloid accumulation associated with lymphatic circulation disorder.
- Able to provide written informed consent to participate in the study voluntarily.
Who cannot join
- Unable to undergo follow-up evaluation for at least 12 months after surgery.
- Diagnosed with vascular dementia.
- Presence of structural brain disease other than intracranial lymphatic circulation disorder.
- Known hypersensitivity to indocyanine green (ICG).
- Uncontrolled systemic medical conditions such as severe cardiopulmonary, renal, hepatic, or endocrine disorders.
- History of previous neck surgery.
- Refusal to participate or failure to provide informed consent.
- Determined by the principal investigator to be unsuitable for participation due to any other clinical reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul
Joonpio Hong, MD, PhD, +821074753606, joonphong@amc.seoul.kr
Jin geon Hong, Guen, MD, PhD, ione2bbest@naver.com
About this study
Official title: Effect of Cervical Lymphaticovenous Anastomosis and Cervical Lymph Node to Vein Anastomosis for the Patient With Intracranial Lymphatic Circulation Disorder
This study is a single-center, prospective clinical trial designed to evaluate the therapeutic effects of lymphaticovenular anastomosis (LVA) and lymph node-venous anastomosis (LNVA) in patients with intracranial lymphatic circulation disorders. Following voluntary written informed consent, screening assessments will be performed in accordance with the clinical trial protocol. Eligibility will be determined based on the predefined inclusion and exclusion criteria, and eligible subjects will be enrolled in the study. Enrolled participants will undergo cognitive function assessments at baseline (pre-surgery) and at 1, 3, 6, 9, 12, 18, and 24 months postoperatively for follow-up. Cognitive evaluations will not be additionally performed for research purposes but will be conducted in accordance with the existing clinical care schedule and standard treatment guidelines.
Read the detailed description
There are several theories regarding the causes of mild cognitive impairment (MCI) and dementia, and one of the commonly proposed mechanisms involves the accumulation of amyloid, a metabolic waste product, within the brain parenchyma. This accumulation is thought to result from impaired clearance of waste from the brain. Accordingly, impaired function of the brain's waste drainage system may contribute to the development of cognitive symptoms.
Because waste clearance from the brain occurs through lymphatic pathways, dysfunction of lymphatic circulation has been identified as an important contributing factor to MCI and dementia. However, due to the minute diameter of lymphatic vessels-typically less than 1 mm-direct therapeutic interventions targeting lymphatic function have long remained unexplored.
Recent advances in supermicrosurgical techniques have enabled procedures on lymphatic vessels as small as 0.2-0.3 mm, leading to the development of novel treatments for lymphatic circulation disorders. For example, patients with upper or lower extremity lymphedema, a representative condition of lymphatic dysfunction, have shown significant improvement following lymphaticovenular anastomosis (LVA) or lymph node-venous anastomosis (LNVA).
Lymphedema results from obstruction or damage to lymphatic pathways, causing the accumulation of lymphatic fluid in tissues. LVA and LNVA are microsurgical procedures that create new bypass routes by connecting lymphatic vessels or lymph nodes directly to adjacent veins, thereby allowing lymphatic fluid to drain into the venous system and re-enter systemic circulation. These procedures have been performed for more than two decades, with excellent therapeutic outcomes reported over the past five years. At Asan Medical Center, more than 100 such procedures are successfully performed annually.
Furthermore, based on the same principle applied in limb lymphedema, recent case-level studies have suggested that performing LVA or LNVA in lymphatic pathways or lymph nodes responsible for cerebral waste clearance may improve degenerative neurological conditions, including Alzheimer's disease. Based on this accumulated knowledge and surgical expertise, cervical lymphaticovenular anastomosis and cervical lymph node-venous anastomosis will be performed to connect lymphatic vessels and lymph nodes involved in cerebral lymphatic drainage to adjacent veins.
It is hypothesized that this procedure may help slow disease progression, preserve quality of life, and potentially improve cognitive function in patients with mild cognitive impairment or dementia.
- Being tested
- Cervical Lymphaticovenous and Lymph Node-to-Vein Anastomosis
- Keywords
- Lymphaticovenous Anastomosis (LVA), Lymph Node-to-Vein Anastomosis (LNVA), Amyloid Clearance, Cognitive Function, Dementia
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Lymphaticovenous and Lymph Node-to-Vein AnastomosisProcedure or surgery
This microsurgical procedure involves connecting the cervical lymphatic vessels and lymph nodes to adjacent veins to enhance lymphatic drainage from the brain. The purpose of the surgery is to reduce amyloid accumulation and improve cognitive function in patients with intracranial lymphatic circulation disorders.
Before the operation, ultrasound imaging is used to identify the lymphatic vessels, lymph nodes, and nearby veins. A small incision of approximately 2-3 cm is made along the sternocleidomastoid muscle. Indocyanine green (ICG) dye is injected to visualize lymphatic flow, and under microscopic guidance, the lymphatic structures are anastomosed to the adjacent veins. Finally, the incision is closed with adhesive, and no postoperative drainage is required.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Intervention Group | Experimental | Participants in this group will undergo cervical lymphaticovenous anastomosis (LVA) and cervical lymph node-to-vein anastomosis (LNVA).
The procedure connects cervical lymphatic vessels and lymph nodes to adjacent veins to facilitate lymphatic drainage from the brain and reduce amyloid accumulation associated with intracranial lymphatic circulation disorder in patients with Alzheimer's disease. Receives: Procedure: Cervical Lymphaticovenous and Lymph Node-to-Vein Anastomosis |
| Control Group | No intervention | Participants in this group will receive standard medication therapy only, following the hospital's routine treatment guidelines for Alzheimer's disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Global Deterioration Scale (GDS) Score
Cognitive decline will be assessed using the Global Deterioration Scale (GDS). The GDS score ranges from 1 to 7, with higher scores indicating more severe cognitive impairment. The outcome measure is the change in GDS score from baseline to postoperative follow-up visits. Scores will be compared between the surgical (LVA + LNVA) group and the medication-only control group.
Measured: From preoperative baseline to postoperative Months 1, 3, 6, 9, 12, 18, and 24
Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
Dementia severity will be evaluated using the Clinical Dementia Rating - Sum of Boxes (CDR-SB).
CDR-SB scores range from 0 to 18, with higher scores indicating more severe cognitive impairment The outcome measure is the change in CDR-SB score from baseline to postoperative follow-up visits.
Scores will be compared between the surgical (LVA + LNVA) group and the medication-only control group.
Measured: Preoperative baseline and postoperative Month 12
Change in Korean Mini-Mental State Examination (K-MMSE) Score
Cognitive function will be assessed using the Korean Mini-Mental State Examination (K-MMSE).
K-MMSE scores range from 0 to 30, with higher scores indicating better cognitive function.
The outcome measure is the change in K-MMSE scores from the preoperative baseline to 12 months after surgery.
Scores will be compared between the surgical (LVA + LNVA) group and the medication-only control group.
Measured: From preoperative baseline to postoperative Months 1, 3, 6, 9, 12, 18, and 24
Change in Montreal Cognitive Assessment (MoCA) Score
Cognitive performance will be assessed using the Montreal Cognitive Assessment (MoCA).
MoCA scores range from 0 to 30, with higher scores indicating better cognitive performance.
The outcome measure is the change in MoCA scores from the preoperative baseline to 12 months after surgery.
Scores will be compared between the surgical (LVA + LNVA) group and the medication-only control group.
Measured: Preoperative baseline; postoperative Day 4; Months 1, 3, 6, 9, 12, 18, and 24
Change in Seoul Neuropsychological Screening Battery (SNSB) Score
Cognitive function will be assessed using the Seoul Neuropsychological Screening Battery (SNSB), a comprehensive neuropsychological test battery evaluating multiple cognitive domains including attention, language, visuospatial function, memory, and executive function.
SNSB provides domain-specific and composite scores, with higher scores generally indicating better cognitive performance, depending on the specific subtest.
Score ranges differ across subtests within the SNSB. The outcome measure is the change in SNSB scores from the preoperative baseline to postoperative follow-up assessments.
Scores will be compared between the surgical (LVA + LNVA) group and the medication-only control group.
Measured: Preoperative baseline; postoperative Months 6, 12, and 24
Secondary outcomes (3)
Incidence of Surgical Complications and Adverse Events
Surgical complications and adverse events will be monitored throughout the study period to evaluate the safety of cervical lymphaticovenous and lymph node-to-vein anastomosis.
Complications may include postoperative infection, wound issues, bleeding, lymphatic leakage, anesthetic complications, or other procedure-related adverse events.
Adverse events will be recorded according to clinical severity and temporal relationship to the intervention.
The outcome measure is the incidence and type of complications occurring during the follow-up period.
Measured: From the day of surgery through postoperative Month 24
Change in Amyloid-Related Blood Biomarkers
The outcome measure is the change from the preoperative baseline to postoperative follow-up assessments in pre-specified amyloid-related blood biomarkers (e.g., amyloid-beta-related markers). Changes in amyloid-related blood biomarkers will be compared between the surgical (LVA + LNVA) group and the medication-only control group.
Measured: Preoperative baseline; postoperative Months 1, 3, 6, 12, and 24
Change in Blood Biomarkers of Neurodegeneration
The outcome measure is the change from the preoperative baseline to postoperative follow-up assessments in pre-specified blood biomarkers of neurodegeneration (e.g., phosphorylated tau). Changes in neurodegeneration-related blood biomarkers will be compared between the surgical (LVA + LNVA) group and the medication-only control group.
Measured: Preoperative baseline; postoperative Months 1, 3, 6, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start20 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Lymphatic Circulation DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of two parallel groups: 1. a surgical intervention group receiving cervical lymphaticovenous and lymph node-to-vein anastomosis plus standard medical therapy, and 2. a control group receiving standard medical therapy alone. The two groups will be followed over the same time points to compare changes in cognitive and clinical outcomes.
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Joonpio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hong Joonpio, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328386
- Sponsor's protocol ID
- 2025-0033
- Acronym
- CLVA-CLNA-ICLC
- Status last verified
- Jan 2026
- First submitted
- 25 Nov 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cervical Lymphaticovenous Anastomosis and Cervical Lymph Node to Vein Anastomosis for the Patient With Intracranial Lymphatic Circulation Disorder
- ClinicalTrials.gov ID
- NCT07328386
- Acronym / sponsor ID
- CLVA-CLNA-ICLC / 2025-0033
- Keywords
- Lymphaticovenous Anastomosis (LVA), Lymph Node-to-Vein Anastomosis (LNVA), Amyloid Clearance, Cognitive Function, Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Hong JoonpioUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jan 2026 (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.
This study is a single-center, prospective clinical trial designed to evaluate the therapeutic effects of lymphaticovenular anastomosis (LVA) and lymph node-venous anastomosis (LNVA) in patients with intracranial lymphatic circulation disorders. Following voluntary written informed consent, screening assessments will be performed in accordance with the clinical trial protocol. Eligibility will be determined based on the predefined inclusion and exclusion criteria, and eligible subjects will be enrolled in the study. Enrolled participants will undergo cognitive function assessments at baseline (pre-surgery) and at 1, 3, 6, 9, 12, 18, and 24 months postoperatively for follow-up. Cognitive evaluations will not be additionally performed for research purposes but will be conducted in accordance with the existing clinical care schedule and standard treatment guidelines.
Detailed description
There are several theories regarding the causes of mild cognitive impairment (MCI) and dementia, and one of the commonly proposed mechanisms involves the accumulation of amyloid, a metabolic waste product, within the brain parenchyma. This accumulation is thought to result from impaired clearance of waste from the brain. Accordingly, impaired function of the brain's waste drainage system may contribute to the development of cognitive symptoms.
Because waste clearance from the brain occurs through lymphatic pathways, dysfunction of lymphatic circulation has been identified as an important contributing factor to MCI and dementia. However, due to the minute diameter of lymphatic vessels-typically less than 1 mm-direct therapeutic interventions targeting lymphatic function have long remained unexplored.
Recent advances in supermicrosurgical techniques have enabled procedures on lymphatic vessels as small as 0.2-0.3 mm, leading to the development of novel treatments for lymphatic circulation disorders. For example, patients with upper or lower extremity lymphedema, a representative condition of lymphatic dysfunction, have shown significant improvement following lymphaticovenular anastomosis (LVA) or lymph node-venous anastomosis (LNVA).
Lymphedema results from obstruction or damage to lymphatic pathways, causing the accumulation of lymphatic fluid in tissues. LVA and LNVA are microsurgical procedures that create new bypass routes by connecting lymphatic vessels or lymph nodes directly to adjacent veins, thereby allowing lymphatic fluid to drain into the venous system and re-enter systemic circulation. These procedures have been performed for more than two decades, with excellent therapeutic outcomes reported over the past five years. At Asan Medical Center, more than 100 such procedures are successfully performed annually.
Furthermore, based on the same principle applied in limb lymphedema, recent case-level studies have suggested that performing LVA or LNVA in lymphatic pathways or lymph nodes responsible for cerebral waste clearance may improve degenerative neurological conditions, including Alzheimer's disease. Based on this accumulated knowledge and surgical expertise, cervical lymphaticovenular anastomosis and cervical lymph node-venous anastomosis will be performed to connect lymphatic vessels and lymph nodes involved in cerebral lymphatic drainage to adjacent veins.
It is hypothesized that this procedure may help slow disease progression, preserve quality of life, and potentially improve cognitive function in patients with mild cognitive impairment or dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to one of two parallel groups: 1. a surgical intervention group receiving cervical lymphaticovenous and lymph node-to-vein anastomosis plus standard medical therapy, and 2. a control group receiving standard medical therapy alone. The two groups will be followed over the same time points to compare changes in cognitive and clinical outcomes.
| Arm | Type | Receives |
|---|---|---|
| Surgical Intervention Group | Experimental | Procedure: Cervical Lymphaticovenous and Lymph Node-to-Vein AnastomosisParticipants in this group will undergo cervical lymphaticovenous anastomosis (LVA) and cervical lymph node-to-vein anastomosis (LNVA). The procedure connects cervical lymphatic vessels and lymph nodes to adjacent veins to facilitate lymphatic drainage from the brain and reduce amyloid accumulation associated with intracranial lymphatic circulation disorder in patients with Alzheimer's disease. |
| Control Group | No intervention | –Participants in this group will receive standard medication therapy only, following the hospital's routine treatment guidelines for Alzheimer's disease. |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 19 years or older who are diagnosed with intracranial lymphatic circulation disorder based on neurological evaluation.
- Global Deterioration Scale (GDS) score between 3 and 5 at screening.
- Diagnosis of Alzheimer's disease confirmed by amyloid PET-CT or CSF amyloid testing, showing amyloid accumulation associated with lymphatic circulation disorder.
- Able to provide written informed consent to participate in the study voluntarily.
Key exclusion criteria (8 listed)
- Unable to undergo follow-up evaluation for at least 12 months after surgery.
- Diagnosed with vascular dementia.
- Presence of structural brain disease other than intracranial lymphatic circulation disorder.
- Known hypersensitivity to indocyanine green (ICG).
- Uncontrolled systemic medical conditions such as severe cardiopulmonary, renal, hepatic, or endocrine disorders.
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 |
|---|---|---|
| Cervical Lymphaticovenous and Lymph Node-to-Vein AnastomosisThis microsurgical procedure involves connecting the cervical lymphatic vessels and lymph nodes to adjacent veins to enhance lymphatic drainage from the brain. The purpose of the surgery is to reduce amyloid accumulation and improve cognitive function in patients with intracranial lymphatic circulation disorders. Before the operation, ultrasound imaging is used to identify the lymphatic vessels, lymph nodes, and nearby veins. A small incision of approximately 2-3 cm is made along the sternocleidomastoid muscle. Indocyanine green (ICG) dye is injected to visualize lymphatic flow, and under microscopic guidance, the lymphatic structures are anastomosed to the adjacent veins. Finally, the incision is closed with adhesive, and no postoperative drainage is required. | Procedure or surgery | Surgical Intervention Group |
Primary outcome
Change in Global Deterioration Scale (GDS) Score
Time frame: From preoperative baseline to postoperative Months 1, 3, 6, 9, 12, 18, and 24
Cognitive decline will be assessed using the Global Deterioration Scale (GDS). The GDS score ranges from 1 to 7, with higher scores indicating more severe cognitive impairment. The outcome measure is the change in GDS score from baseline to postoperative follow-up visits. Scores will be compared between the surgical (LVA + LNVA) group and the medication-only control group.
Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
Time frame: Preoperative baseline and postoperative Month 12
Dementia severity will be evaluated using the Clinical Dementia Rating - Sum of Boxes (CDR-SB). CDR-SB scores range from 0 to 18, with higher scores indicating more severe cognitive impairment The outcome measure is the change in CDR-SB score from baseline to postoperative follow-up visits. Scores will be compared between the surgical (LVA + LNVA) group and the medication-only control group.
Change in Korean Mini-Mental State Examination (K-MMSE) Score
Time frame: From preoperative baseline to postoperative Months 1, 3, 6, 9, 12, 18, and 24
Cognitive function will be assessed using the Korean Mini-Mental State Examination (K-MMSE). K-MMSE scores range from 0 to 30, with higher scores indicating better cognitive function. The outcome measure is the change in K-MMSE scores from the preoperative baseline to 12 months after surgery. Scores will be compared between the surgical (LVA + LNVA) group and the medication-only control group.
Change in Montreal Cognitive Assessment (MoCA) Score
Time frame: Preoperative baseline; postoperative Day 4; Months 1, 3, 6, 9, 12, 18, and 24
Cognitive performance will be assessed using the Montreal Cognitive Assessment (MoCA). MoCA scores range from 0 to 30, with higher scores indicating better cognitive performance. The outcome measure is the change in MoCA scores from the preoperative baseline to 12 months after surgery. Scores will be compared between the surgical (LVA + LNVA) group and the medication-only control group.
Change in Seoul Neuropsychological Screening Battery (SNSB) Score
Time frame: Preoperative baseline; postoperative Months 6, 12, and 24
Cognitive function will be assessed using the Seoul Neuropsychological Screening Battery (SNSB), a comprehensive neuropsychological test battery evaluating multiple cognitive domains including attention, language, visuospatial function, memory, and executive function. SNSB provides domain-specific and composite scores, with higher scores generally indicating better cognitive performance, depending on the specific subtest. Score ranges differ across subtests within the SNSB. The outcome measure is the change in SNSB scores from the preoperative baseline to postoperative follow-up assessments. Scores will be compared between the surgical (LVA + LNVA) group and the medication-only control group.
3 secondary outcomes
Incidence of Surgical Complications and Adverse Events
Time frame: From the day of surgery through postoperative Month 24
Change in Amyloid-Related Blood Biomarkers
Time frame: Preoperative baseline; postoperative Months 1, 3, 6, 12, and 24
Change in Blood Biomarkers of Neurodegeneration
Time frame: Preoperative baseline; postoperative Months 1, 3, 6, 12, and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Lymphaticovenous and Lymph Node-to-Vein Anastomosis in people with Intracranial Lymphatic Circulation Disorder and Alzheimer's Disease, run by Hong Joonpio at 1 site in South Korea.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 9 Jan 2026. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jin geon Guen, MD, PhD (+82230103600, ione2bbest@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Global Deterioration Scale (GDS) Score (time frame: From preoperative baseline to postoperative Months 1, 3, 6, 9, 12, 18, and 24). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2026.