Spinal Cord Injuries (SCI)NCT07306052
Epidural Spinal Cord Stimulation for Restoring Walking in Spinal Cord Injury
A study testing Epidural spinal cord stimulation, Rehabilitation Therapy and positron emission tomography-computed tomography (PET-CT) in people with Spinal Cord Injuries (SCI), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) combined with rehabilitation training for the reconstruction of walking in patients with chronic spinal cord injury (SCI) classified as AIS B-D. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Spinal Cord Injuries (SCI)
- What is being tested?
- Epidural spinal cord stimulation, Rehabilitation Therapy and positron emission tomography-computed tomography (PET-CT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2025to Jun 2027
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age between 16 and 70 years.
- Diagnosed with traumatic spinal cord injury for ≥ 6 months and ≤ 60 months.
- American Spinal Injury Association Impairment Scale (AIS) grade B-D.
- Spinal cord injury level above T10;
- Walking Index for Spinal Cord Injury II (WISCI II) score ≤ 13.
- Completion of a standard conventional rehabilitation program prior to enrollment.
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- Preserved upper limb function sufficient for self-propelling a manual wheelchair.
- Sitting balance grade ≥ 1.
- Ability to elicit clear electromyographic responses in lower limb muscles (e.g., rectus femoris, biceps femoris, gastrocnemius, tibialis anterior) upon transcutaneous electrical spinal cord stimulation at the T12-L1 vertebral levels.
- Willingness to voluntarily participate, and commitment to compliance with all necessary postoperative rehabilitation, assessments, and follow-up visits.
Who cannot join
- History of myocardial infarction or stroke within the past 6 months.
- Diagnosis of psychiatric disorders with active suicidal ideation or risk.
- Current pregnancy or planned pregnancy during the study period.
- Bleeding tendency or coagulopathy (prothrombin time ≥18 seconds).
- History of alcohol or substance abuse or dependence.
- Intellectual disability, cognitive impairment, or personality disorders.
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- Other chronic medical conditions that may interfere with rehabilitation (e.g., unhealed severe fractures, hepatic or renal failure, severe anemia, etc.).
- Implantation of cardiac pacemakers, cardioverters, or defibrillators.
- Any other condition deemed inappropriate for participation by the investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Junming Zhu, Chief Physician, 0571-87784716, dr.zhujunming@zju.edu.cn
Zhoule Zhu, Attending Physician, 0571-87784716, doczhuzl@zju.edu.cn
About this study
Official title: Safety and Efficacy of Epidural Spinal Cord Stimulation for Restoring Walking in Spinal Cord Injury
The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) combined with rehabilitation training for the reconstruction of walking in patients with chronic spinal cord injury (SCI) classified as AIS B-D. The main questions it aims to answer are:
Does the intervention of EES combined with rehabilitation significantly improve walking capacity? Is the combined intervention a safe approach for this patient population? Researchers will compare participants' functional assessments before EES implantation and at 2, 4, 7, 10, and 13 months post-implantation to evaluate the longitudinal effects. The primary assessments include the Walking Index for Spinal Cord Injury II (WISCI II), the Spinal Cord Independence Measure (SCIM III), and the adverse event. Secondary outcome measures encompass the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), the Functional Independence Measure (FIM), the Modified Ashworth Scale (MAS), the Penn Spasm Frequency Scale, the 10-Meter Walk Test (10mWT), the 6-Minute Walk Test (6minWT), and pain Visual Analogue Scale (VAS) scores. Neurophysiological and imaging evaluations, including electromyography (EMG), motor evoked potentials (MEPs), somatosensory evoked potentials (SEPs), and positron emission tomography-computed tomography (PET-CT), will be conducted preoperatively and at 6 months postoperatively to explore the mechanisms of neuroplasticity.
Read more
Participants will:
Undergo surgical implantation of an EES device. Receive personalized EES parameter programming combined with rehabilitation training (≥2 hours daily) post-operatively.
Complete a series of standardized functional and clinical outcome assessments at scheduled follow-up intervals.
Undergo scheduled neurophysiological and metabolic imaging studies. Report any adverse events throughout the study duration.
- Conditions
- Spinal Cord Injuries (SCI)
- Being tested
- Epidural spinal cord stimulation, Rehabilitation Therapy, positron emission tomography-computed tomography (PET-CT), Somatosensory Evoked Potentials (SEPs), Motor Evoked Potentials (MEPs)
- Keywords
- Epidural Electrical Stimulation, Spincal cord stimulation, Spincal cord injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural spinal cord stimulationProcedure or surgery
Epidural spinal cord stimulation is a medical technology that involves delivering controlled electrical impulses to the spinal cord through electrodes implanted in the epidural space-the area between the outermost membrane of the spinal cord (dura mater) and the vertebrae. This technique aims to modulate the activity of spinal neural networks, thereby regulating neurological functions and promoting functional recovery, particularly in individuals with spinal cord injuries or certain neurological disorders.
Rehabilitation TherapyProcedure or surgery
A structured, multidisciplinary rehabilitation program designed to improve motor function, mobility, and independence in participants with paralysis. The therapy typically includes physical Therapy and occupational Therapy.
positron emission tomography-computed tomography (PET-CT)Radiation
PET-CT is an advanced hybrid imaging modality that combines metabolic information from positron emission tomography with anatomical details from computed tomography.
Somatosensory Evoked Potentials (SEPs)Procedure or surgery
SEPs are electrophysiological responses recorded from the central or peripheral nervous system following electrical stimulation of sensory nerves. They assess the functional integrity of somatosensory pathways.
Motor Evoked Potentials (MEPs)Procedure or surgery
MEPs are electrophysiological responses elicited by transcranial magnetic stimulation or electrical stimulation of the motor cortex, recorded from peripheral muscles or the spinal cord. They evaluate the integrity of corticospinal tracts.
Diffusion Tensor Imaging (DTI)Radiation
DTI is an advanced MRI technique that maps white matter tracts by measuring the directionality (anisotropy) and magnitude of water molecule diffusion in neural tissues. It provides quantitative metrics of fibers.
| Study group | Role | What they receive |
|---|---|---|
| Epidural spinal cord stimulation + Standard Rehabilitation | Experimental | Participants receive the epidural spnial cord stimulation combined with individualized standard rehabilitation therapy for 12 months. Receives: Procedure: Epidural spinal cord stimulation; Procedure: Rehabilitation Therapy; Radiation: positron emission tomography-computed tomography (PET-CT); Procedure: Somatosensory Evoked Potentials (SEPs); Procedure: Motor Evoked Potentials (MEPs); Radiation: Diffusion Tensor Imaging (DTI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
The incidence, severity, and relationship to the intervention of all AEs . All AEs will be defined, recorded, and graded according to the International Council for Harmonisation Good Clinical Practice guidelines. Serious adverse events will be reported specifically based on established criteria. This assessment will comprehensively cover all safety concerns related to the surgical procedure (epidural stimulator implantation), the electrical stimulation itself (across various parameter sets).
Measured: Entire study period from implantation to the 13-month postoperative follow-up.
WISCI II (Walking Index for Spinal Cord Injury II)
The WISCI II evaluates walking ability in spinal cord injury patients. It has 21 levels (0-20), with scores based on mobility aids and assistance needed. A score of 0 means no walking; 20 indicates independent walking without aids.
Measured: baseline, and 2, 4, 7, 13 monthes after surgery.
Spinal Cord Independence Measure III (SCIM III)
SCIM III is a disease-specific, validated assessment tool designed to evaluate the functional independence of individuals with spinal cord injury in performing essential activities of daily living, self-care, mobility, and respiration/management. It is tailored to reflect the unique challenges and priorities of the SCI population.
The SCIM III consists of 19 items across three subscales:
Self-care subscale (0-20 points): Includes feeding, grooming, bathing, and dressing.
Respiration and sphincter management subscale (0-40 points): Covers respiration, bladder management, and bowel management.
Mobility subscale (0-40 points): Assesses mobility in room and toilet, indoors and outdoors mobility, and stair management.
The total score ranges from 0 to 100 points, with higher scores indicating greater functional independence.
Measured: baseline, and 2, 4, 7, 13 months after surgery
Secondary outcomes (7)
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
ISNCSCI is the most authoritative and widely used standard for evaluating neurological function after spinal cord injury, comprising:
Motor Scores:
Range:
Upper limbs (C5-T1): 0-25 per limb (total 0-50) Lower limbs (L2-S1): 0-25 per limb (total 0-50) Total motor score: 0-100 points Higher scores indicate better motor function
Sensory Scores:
Light touch:
0-2 points per dermatome (C2-S4/5) Total: 0-112 points
Pinprick:
0-2 points per dermatome (C2-S4/5) Total: 0-112 points Interpretation: Higher scores indicate better sensory preservation Neurological Level of Injury: determined by the most caudal segment
ASIA Impairment Scale (AIS) Grading:
A = Complete (no motor/sensory function in S4-S5) B = Sensory incomplete C = Motor incomplete (<50% key muscles strength ≥3/5 grade) D = Motor incomplete (≥50% key muscles strength ≥3/5 grade) E = Normal
Measured: baseline, and 2, 4, 7, 13 monthes after surgery
Functional Independence Measure (FIM)
The Functional Independence Measure (FIM) is a widely used assessment tool designed to evaluate a person's functional status and level of independence in daily living activities, particularly among individuals with disabilities.
FIM items are scored based on the level of assistance required to complete a task, ranging from 1 to 7 points per item.
The FIM consists of 18 items across two domains: Motor domain (13 items): Includes activities such as eating, grooming, bathing, dressing, toileting, transfers (bed/chair, toilet, tub/shower), walking, and stair climbing. Cognitive domain (5 items): Covers communication (comprehension and expression) and social cognition (memory, problem-solving, and social interaction).
The total score ranges from 18 to 126 points:
≤ 35 points: Severe dependence 36-89 points: Moderate dependence 90-119 points: Mild dependence 120-126 points: Functional independence
Measured: baseline, and 2, 4, 7, 13 months after surgery
The 10-Meter Walk Test (10m-WT)
10mWT is a widely used, objective performance-based assessment tool designed to evaluate short-distance walking speed and functional mobility in individuals with neurological impairments, including spinal cord injury.
The time taken to walk the middle 6 meters is recorded in seconds.
Measured: baseline, and 2, 4, 7, 10, 13 monthes after surgery
The 6-Minute Walk Test (6min-WT)
The 6min-WT is a widely used, objective performance-based assessment tool designed to evaluate submaximal exercise capacity, functional endurance, and walking distance in individuals with chronic cardiopulmonary or neurological conditions, including spinal cord injury.
The participant is instructed to walk back and forth as far as possible within the 6-minute time period, at a self-selected pace that can be sustained throughout the test.
Measured: baseline, and 2, 4, 7, 10, 13 monthes after surgery
Modified Ashworth Scale (MAS)
MAS is a clinical tool used to assess muscle spasticity by grading resistance during passive movement. It scores from 0 (no tone increase) to 4 (rigid joint), with intermediate grades: 1 (slight resistance), 1+ (mild resistance through ≤50% ROM), 2 (marked resistance), and 3 (considerable resistance). Higher MAS scores (max=4) indicate worse outcomes, reflecting more severe spasticity that impairs mobility.
Measured: baseline, and 2, 4, 7, 13 monthes after surgery
Penn
The Penn Scale is a specific assessment tool for measuring muscle spasticity. Scores range from 0 (no spasticity) to 4 (severe, rigid spasticity), with higher scores indicating more intense muscle stiffness and involuntary contractions.
Measured: baseline, and 2, 4, 7, 13 months after surgery
Visual Analog Scale (VAS) Pain Score
The VAS Pain Score is a self-reported measure of pain intensity. It consists of a 10-cm horizontal line, anchored by "no pain" (0) on one end and "worst pain imaginable" (10) on the other. Patients mark the line to represent their current pain level, and the score is determined by measuring the distance from "no pain." It provides a simple, quick method to quantify subjective pain experiences, monitor fluctuations, and guide pain management strategies.
Measured: baseline, and 2, 4, 7, 13 monthes after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start12 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University
- Responsible party
- Principal investigator, Junming Zhu, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Junming Zhu, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306052
- Sponsor's protocol ID
- 2025-1940
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Epidural Spinal Cord Stimulation for Restoring Walking in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07306052
- Acronym / sponsor ID
- 2025-1940
- Conditions
- Spinal Cord Injuries (SCI)
- Keywords
- Epidural Electrical Stimulation, Spincal cord stimulation, Spincal cord injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Zhejiang University
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Dec 2025 (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 goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) combined with rehabilitation training for the reconstruction of walking in patients with chronic spinal cord injury (SCI) classified as AIS B-D. The main questions it aims to answer are:
Does the intervention of EES combined with rehabilitation significantly improve walking capacity? Is the combined intervention a safe approach for this patient population? Researchers will compare participants' functional assessments before EES implantation and at 2, 4, 7, 10, and 13 months post-implantation to evaluate the longitudinal effects. The primary assessments include the Walking Index for Spinal Cord Injury II (WISCI II), the Spinal Cord Independence Measure (SCIM III), and the adverse event. Secondary outcome measures encompass the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), the Functional Independence Measure (FIM), the Modified Ashworth Scale (MAS), the Penn Spasm Frequency Scale, the 10-Meter Walk Test (10mWT), the 6-Minute Walk Test (6minWT), and pain Visual Analogue Scale (VAS) scores. Neurophysiological and imaging evaluations, including electromyography (EMG), motor evoked potentials (MEPs), somatosensory evoked potentials (SEPs), and positron emission tomography-computed tomography (PET-CT), will be conducted preoperatively and at 6 months postoperatively to explore the mechanisms of neuroplasticity.
Participants will:
Undergo surgical implantation of an EES device. Receive personalized EES parameter programming combined with rehabilitation training (≥2 hours daily) post-operatively.
Complete a series of standardized functional and clinical outcome assessments at scheduled follow-up intervals.
Undergo scheduled neurophysiological and metabolic imaging studies. Report any adverse events throughout the study duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidural spinal cord stimulation + Standard Rehabilitation | Experimental | Procedure: Epidural spinal cord stimulation, Procedure: Rehabilitation Therapy, Radiation: positron emission tomography-computed tomography (PET-CT), Procedure: Somatosensory Evoked Potentials (SEPs), Procedure: Motor Evoked Potentials (MEPs), Radiation: Diffusion Tensor Imaging (DTI)Participants receive the epidural spnial cord stimulation combined with individualized standard rehabilitation therapy for 12 months. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Age between 16 and 70 years.
- Diagnosed with traumatic spinal cord injury for ≥ 6 months and ≤ 60 months.
- American Spinal Injury Association Impairment Scale (AIS) grade B-D.
- Spinal cord injury level above T10;
- Walking Index for Spinal Cord Injury II (WISCI II) score ≤ 13.
Key exclusion criteria (9 listed)
- History of myocardial infarction or stroke within the past 6 months.
- Diagnosis of psychiatric disorders with active suicidal ideation or risk.
- Current pregnancy or planned pregnancy during the study period.
- Bleeding tendency or coagulopathy (prothrombin time ≥18 seconds).
- History of alcohol or substance abuse or dependence.
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 |
|---|---|---|
| Epidural spinal cord stimulationEpidural spinal cord stimulation is a medical technology that involves delivering controlled electrical impulses to the spinal cord through electrodes implanted in the epidural space-the area between the outermost membrane of the spinal cord (dura mater) and the vertebrae. This technique aims to modulate the activity of spinal neural networks, thereby regulating neurological functions and promoting functional recovery, particularly in individuals with spinal cord injuries or certain neurological disorders. | Procedure or surgery | Epidural spinal cord stimulation + Standard Rehabilitation |
| Rehabilitation TherapyA structured, multidisciplinary rehabilitation program designed to improve motor function, mobility, and independence in participants with paralysis. The therapy typically includes physical Therapy and occupational Therapy. | Procedure or surgery | Epidural spinal cord stimulation + Standard Rehabilitation |
| positron emission tomography-computed tomography (PET-CT)PET-CT is an advanced hybrid imaging modality that combines metabolic information from positron emission tomography with anatomical details from computed tomography. | Radiation | Epidural spinal cord stimulation + Standard Rehabilitation |
| Somatosensory Evoked Potentials (SEPs)SEPs are electrophysiological responses recorded from the central or peripheral nervous system following electrical stimulation of sensory nerves. They assess the functional integrity of somatosensory pathways. | Procedure or surgery | Epidural spinal cord stimulation + Standard Rehabilitation |
| Motor Evoked Potentials (MEPs)MEPs are electrophysiological responses elicited by transcranial magnetic stimulation or electrical stimulation of the motor cortex, recorded from peripheral muscles or the spinal cord. They evaluate the integrity of corticospinal tracts. | Procedure or surgery | Epidural spinal cord stimulation + Standard Rehabilitation |
| Diffusion Tensor Imaging (DTI)DTI is an advanced MRI technique that maps white matter tracts by measuring the directionality (anisotropy) and magnitude of water molecule diffusion in neural tissues. It provides quantitative metrics of fibers. | Radiation | Epidural spinal cord stimulation + Standard Rehabilitation |
Primary outcome
Adverse Events (AEs)
Time frame: Entire study period from implantation to the 13-month postoperative follow-up.
The incidence, severity, and relationship to the intervention of all AEs . All AEs will be defined, recorded, and graded according to the International Council for Harmonisation Good Clinical Practice guidelines. Serious adverse events will be reported specifically based on established criteria. This assessment will comprehensively cover all safety concerns related to the surgical procedure (epidural stimulator implantation), the electrical stimulation itself (across various parameter sets).
WISCI II (Walking Index for Spinal Cord Injury II)
Time frame: baseline, and 2, 4, 7, 13 monthes after surgery.
The WISCI II evaluates walking ability in spinal cord injury patients. It has 21 levels (0-20), with scores based on mobility aids and assistance needed. A score of 0 means no walking; 20 indicates independent walking without aids.
Spinal Cord Independence Measure III (SCIM III)
Time frame: baseline, and 2, 4, 7, 13 months after surgery
SCIM III is a disease-specific, validated assessment tool designed to evaluate the functional independence of individuals with spinal cord injury in performing essential activities of daily living, self-care, mobility, and respiration/management. It is tailored to reflect the unique challenges and priorities of the SCI population. The SCIM III consists of 19 items across three subscales: Self-care subscale (0-20 points): Includes feeding, grooming, bathing, and dressing. Respiration and sphincter management subscale (0-40 points): Covers respiration, bladder management, and bowel management. Mobility subscale (0-40 points): Assesses mobility in room and toilet, indoors and outdoors mobility, and stair management. The total score ranges from 0 to 100 points, with higher scores indicating greater functional independence.
7 secondary outcomes
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Time frame: baseline, and 2, 4, 7, 13 monthes after surgery
Functional Independence Measure (FIM)
Time frame: baseline, and 2, 4, 7, 13 months after surgery
The 10-Meter Walk Test (10m-WT)
Time frame: baseline, and 2, 4, 7, 10, 13 monthes after surgery
The 6-Minute Walk Test (6min-WT)
Time frame: baseline, and 2, 4, 7, 10, 13 monthes after surgery
Modified Ashworth Scale (MAS)
Time frame: baseline, and 2, 4, 7, 13 monthes after surgery
Penn
Time frame: baseline, and 2, 4, 7, 13 months after surgery
Visual Analog Scale (VAS) Pain Score
Time frame: baseline, and 2, 4, 7, 13 monthes after surgery
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 29 May 2026.
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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.
Junming Zhu principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural spinal cord stimulation, Rehabilitation Therapy and positron emission tomography-computed tomography (PET-CT) in people with Spinal Cord Injuries (SCI), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 10 inclusion and 9 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 29 May 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 China. 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 Junming Zhu, Chief Physician (0571-87784716, dr.zhujunming@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) (time frame: Entire study period from implantation to the 13-month postoperative follow-up.). The study lists 3 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 29 May 2026.