Pelvic FractureNCT07624942
Robot Assisted Treatment Versus Conventional Surgery for Tile B and C Pelvic Fractures
A study testing Robot Assisted Minimally Invasive Fixation in people with Pelvic Fracture, run by Junbo Liang.
Trial summary
This prospective randomized controlled trial aims to compare the efficacy and safety of robot assisted treatment versus conventional surgery in patients with Tile B and C pelvic fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Fracture
- What is being tested?
- Robot Assisted Minimally Invasive Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 Dec 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Diagnosis of Tile B or Tile C pelvic fracture
- Injury duration less than 3 weeks
- Ability to provide written informed consent
Who cannot join
- Severe open injury or skin infection at the surgical site
- Hemodynamic instability preventing anesthesia or surgery
- Severe psychiatric disorders or dementia
- Severe obesity affecting imaging quality
- Severe systemic diseases preventing surgery
- Pathological fracture
- Current chemotherapy, radiotherapy, systemic corticosteroid therapy, or growth factor therapy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing the Efficacy and Safety of Robot Assisted Treatment Versus Conventional Surgery in Patients With Tile B and C Pelvic Fractures
This prospective randomized controlled trial aims to compare the efficacy and safety of robot assisted treatment versus conventional surgery in patients with Tile B and C pelvic fractures. Eligible patients will be stratified according to Tile fracture classification and randomly assigned in a 1:1 ratio to receive either robot assisted minimally invasive fixation or conventional surgical treatment. Primary and secondary outcomes include pain relief, early mobilization, functional recovery, imaging outcomes, perioperative complications, venous thromboembolism events, laboratory parameters, opioid consumption, and healthcare resource utilization. The study aims to provide evidence for optimizing surgical treatment strategies for unstable pelvic fractures.
Read the detailed description
This study is a prospective, single center, stratified randomized controlled trial designed to compare the efficacy and safety of robot assisted treatment versus conventional surgery in patients with Tile B and C pelvic fractures.
A total of 88 patients will be enrolled and randomly assigned in a 1:1 ratio to either the robot assisted treatment group or the conventional surgery group. Randomization will be stratified according to Tile fracture classification (Tile B or Tile C) using a computer generated randomization sequence.
Eligible participants include adult patients diagnosed with Tile B or Tile C pelvic fractures within 3 weeks after injury. The primary objective is to compare perioperative outcomes, pain control, early mobilization, functional recovery, imaging outcomes, complications, opioid consumption, and healthcare resource utilization between treatment strategies.
Patients in the robot assisted treatment group will undergo robot assisted minimally invasive fixation using robotic navigation assisted percutaneous screw placement. Patients in the conventional surgery group will undergo standard open surgical fixation according to fracture characteristics and surgeon judgment.
Outcome measures include pain scores, Majeed pelvic function score, EQ 5D, SMFA, imaging evaluation of fracture healing, laboratory parameters, venous thromboembolism events, opioid consumption, perioperative indicators, complications, and healthcare costs. Follow up assessments will be performed at postoperative day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year.
The results of this study may provide evidence regarding the optimal surgical treatment strategy for Tile B and C pelvic fractures.
- Conditions
- Pelvic Fracture
- Being tested
- Robot Assisted Minimally Invasive Fixation
- Keywords
- Pelvic Fracture, Robot Assisted Surgery
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot Assisted Minimally Invasive FixationProcedure or surgery
Robot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of unstable pelvic fractures.
| Study group | Role | What they receive |
|---|---|---|
| Robot Assisted Treatment Group | Experimental | Participants undergo robot assisted minimally invasive fixation using robotic navigation assisted percutaneous screw placement for Tile B and C pelvic fractures. Receives: Procedure: Robot Assisted Minimally Invasive Fixation |
| Conventional Surgery Group | Active comparator | Participants undergo conventional open surgical fixation for Tile B and C pelvic fractures. Receives: Procedure: Robot Assisted Minimally Invasive Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) for Pain
Visual Analog Scale (VAS) for pain. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain severity.
Measured: At 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 12 hours, day 1, day 2, day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Majeed Pelvic Function Score
The Majeed Pelvic Function Score is used to evaluate functional recovery after pelvic fracture treatment. Scores range from 0 to 100, with higher scores indicating better functional outcomes and quality of life.
Measured: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Secondary outcomes (11)
EuroQol 5-Dimension 3-Level Questionnaire
Health related quality of life assessed using the EuroQol 5-Dimension 3-Level Questionnaire (EQ-5D-3L). The EQ-5D index score ranges from values below 0 (health states considered worse than death) to 1.0 (full health). Higher scores indicate better health related quality of life.
Measured: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Short Musculoskeletal Function Assessment (SMFA)
Musculoskeletal function assessed using the 46-item Short Musculoskeletal Function Assessment (SMFA). Raw questionnaire scores are transformed to a standardized score ranging from 0 to 100. Higher scores indicate worse musculoskeletal function and greater disability.
Measured: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Imaging Outcomes and Fracture Healing
Assessment of fracture healing, secondary displacement, bone mineral density changes, and muscle mass changes using pelvic CT and imaging examinations.
Measured: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Complication
Measured: From treatment initiation to 1 year follow up
Opioid Consumption
Assessment of cumulative opioid consumption during hospitalization
Measured: Postoperative Days 0-3
Serum C-Reactive Protein Level
Measured: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
D-Dimer Level
Measured: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
Hemoglobin Level
Measured: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
Operative Time
Duration of surgery measured in minutes.
Measured: Perioperative
Intraoperative Blood Loss
Estimated intraoperative blood loss measured in milliliters.
Measured: Perioperative
Length of Surgical Incision
Length of skin incision measured in centimeters.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pelvic FractureStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Junbo Liang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Junbo Liang, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624942
- Sponsor's protocol ID
- K20260304
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lu Z, Xiuxiu H, Xing B. Retrospective analysis of the use of orthopedic reduction robots in treating low-energy osteoporotic unstable pelvic fractures in the elderly. J Orthop Surg Res. 2025 Sep 26;20(1):844. doi: 10.1186/s13018-025-06258-1.
PubMed 41013720Zwingmann J, Konrad G, Kotter E, Sudkamp NP, Oberst M. Computer-navigated iliosacral screw insertion reduces malposition rate and radiation exposure. Clin Orthop Relat Res. 2009 Jul;467(7):1833-8. doi: 10.1007/s11999-008-0632-6. Epub 2008 Nov 26.
PubMed 19034594Hoffmann MF, Yilmaz E, Norvel DC, Schildhauer TA. Navigated iliac screw placement may reduce radiation and OR time in lumbopelvic fixation of unstable complex sacral fractures. Eur J Orthop Surg Traumatol. 2021 Oct;31(7):1427-1433. doi: 10.1007/s00590-021-02892-7. Epub 2021 Feb 16.
PubMed 33590317Gericke L, Fritz A, Osterhoff G, Josten C, Pieroh P, Hoch A. Percutaneous operative treatment of fragility fractures of the pelvis may not increase the general rate of complications compared to non-operative treatment. Eur J Trauma Emerg Surg. 2022 Oct;48(5):3729-3735. doi: 10.1007/s00068-021-01660-w. Epub 2021 Apr 3.
PubMed 33811488Ran D, Wang C. Efficacy and safety of different fixation methods for unstable anterior pelvic ring fractures: a Bayesian network meta-analysis. Ann Med. 2025 Dec;57(1):2563000. doi: 10.1080/07853890.2025.2563000. Epub 2025 Oct 6.
PubMed 41054280Lu S, Liu F, Xu W, Zhou X, Li L, Zhou D, Li Q, Dong J. Management of Open Tile C Pelvic Fractures and Their Outcomes: A Retrospective Study of 30 Cases. Ther Clin Risk Manag. 2022 Sep 10;18:929-937. doi: 10.2147/TCRM.S378740. eCollection 2022.
PubMed 36119388de Ridder VA, Whiting PS, Balogh ZJ, Mir HR, Schultz BJ, Routt MC. Pelvic ring injuries: recent advances in diagnosis and treatment. OTA Int. 2023 Jun 16;6(3 Suppl):e261. doi: 10.1097/OI9.0000000000000261. eCollection 2023 Jun.
PubMed 37533441Tienpratarn W, Nakpipat N, Yuksen C, Wongwaisayawan S, Phootothum Y, Jaiboon S. Clinical Associated Factors of Tile B/C Type of Pelvic Ring Fractures; a Retrospective Cross-sectional study. Arch Acad Emerg Med. 2024 May 12;12(1):e49. doi: 10.22037/aaem.v12i1.2243. eCollection 2024.
PubMed 38962370Ding H, Wang W, Sun W, Liu L, Huang M, Han D, Lu Y, Zhou J, Pan J. Clinical characteristics and mortality risk factors in polytrauma patients with pelvic fractures: a retrospective study based on an integrated multidisciplinary treatment approach. Int J Emerg Med. 2025 Oct 6;18(1):192. doi: 10.1186/s12245-025-00990-5.
PubMed 41053562Ohla J, Walus P, Wicinski M, Malkowski B, Turon B, Jablonski A, Gawryjolek M, Kellett K, Zabrzynski J. Pelvic Fractures in Adults and the Importance of Associated Injuries-A Current Multi-Disciplinary Approach. Clin Pract. 2025 Jul 11;15(7):130. doi: 10.3390/clinpract15070130.
PubMed 40710040Hermans E, Biert J, Edwards MJR. Epidemiology of Pelvic Ring Fractures in a Level 1 Trauma Center in the Netherlands. Hip Pelvis. 2017 Dec;29(4):253-261. doi: 10.5371/hp.2017.29.4.253. Epub 2017 Dec 1.
PubMed 29250500
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy and Safety of Robot Assisted Treatment Versus Conventional Surgery in Patients With Tile B and C Pelvic Fractures
- ClinicalTrials.gov ID
- NCT07624942
- Acronym / sponsor ID
- K20260304
- Conditions
- Pelvic Fracture
- Keywords
- Pelvic Fracture, Robot Assisted Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Junbo LiangUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 3 Jun 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 prospective randomized controlled trial aims to compare the efficacy and safety of robot assisted treatment versus conventional surgery in patients with Tile B and C pelvic fractures. Eligible patients will be stratified according to Tile fracture classification and randomly assigned in a 1:1 ratio to receive either robot assisted minimally invasive fixation or conventional surgical treatment. Primary and secondary outcomes include pain relief, early mobilization, functional recovery, imaging outcomes, perioperative complications, venous thromboembolism events, laboratory parameters, opioid consumption, and healthcare resource utilization. The study aims to provide evidence for optimizing surgical treatment strategies for unstable pelvic fractures.
Detailed description
This study is a prospective, single center, stratified randomized controlled trial designed to compare the efficacy and safety of robot assisted treatment versus conventional surgery in patients with Tile B and C pelvic fractures.
A total of 88 patients will be enrolled and randomly assigned in a 1:1 ratio to either the robot assisted treatment group or the conventional surgery group. Randomization will be stratified according to Tile fracture classification (Tile B or Tile C) using a computer generated randomization sequence.
Eligible participants include adult patients diagnosed with Tile B or Tile C pelvic fractures within 3 weeks after injury. The primary objective is to compare perioperative outcomes, pain control, early mobilization, functional recovery, imaging outcomes, complications, opioid consumption, and healthcare resource utilization between treatment strategies.
Patients in the robot assisted treatment group will undergo robot assisted minimally invasive fixation using robotic navigation assisted percutaneous screw placement. Patients in the conventional surgery group will undergo standard open surgical fixation according to fracture characteristics and surgeon judgment.
Outcome measures include pain scores, Majeed pelvic function score, EQ 5D, SMFA, imaging evaluation of fracture healing, laboratory parameters, venous thromboembolism events, opioid consumption, perioperative indicators, complications, and healthcare costs. Follow up assessments will be performed at postoperative day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year.
The results of this study may provide evidence regarding the optimal surgical treatment strategy for Tile B and C pelvic fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot Assisted Treatment Group | Experimental | Procedure: Robot Assisted Minimally Invasive FixationParticipants undergo robot assisted minimally invasive fixation using robotic navigation assisted percutaneous screw placement for Tile B and C pelvic fractures. |
| Conventional Surgery Group | Active comparator | Procedure: Robot Assisted Minimally Invasive FixationParticipants undergo conventional open surgical fixation for Tile B and C pelvic fractures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Diagnosis of Tile B or Tile C pelvic fracture
- Injury duration less than 3 weeks
- Ability to provide written informed consent
Key exclusion criteria (7 listed)
- Severe open injury or skin infection at the surgical site
- Hemodynamic instability preventing anesthesia or surgery
- Severe psychiatric disorders or dementia
- Severe obesity affecting imaging quality
- Severe systemic diseases preventing surgery
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 |
|---|---|---|
| Robot Assisted Minimally Invasive FixationRobot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of unstable pelvic fractures. | Procedure or surgery | Conventional Surgery Group, Robot Assisted Treatment Group |
Primary outcome
Visual Analog Scale (VAS) for Pain
Time frame: At 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 12 hours, day 1, day 2, day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Visual Analog Scale (VAS) for pain. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain severity.
Majeed Pelvic Function Score
Time frame: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
The Majeed Pelvic Function Score is used to evaluate functional recovery after pelvic fracture treatment. Scores range from 0 to 100, with higher scores indicating better functional outcomes and quality of life.
11 secondary outcomes
EuroQol 5-Dimension 3-Level Questionnaire
Time frame: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Short Musculoskeletal Function Assessment (SMFA)
Time frame: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Imaging Outcomes and Fracture Healing
Time frame: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Complication
Time frame: From treatment initiation to 1 year follow up
Opioid Consumption
Time frame: Postoperative Days 0-3
Serum C-Reactive Protein Level
Time frame: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
D-Dimer Level
Time frame: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
Hemoglobin Level
Time frame: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
Operative Time
Time frame: Perioperative
Intraoperative Blood Loss
Time frame: Perioperative
Length of Surgical Incision
Time frame: Perioperative
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 3 Jun 2026.
- Results publication: PubMed 41013720Lu Z, Xiuxiu H, Xing B. Retrospective analysis of the use of orthopedic reduction robots in treating low-energy osteoporotic unstable pelvic fractures in the elderly. J Orthop Surg Res. 2025 Sep 26;20(1):844. doi: 10.1186/s13018-025-06258-1.
- Results publication: PubMed 19034594Zwingmann J, Konrad G, Kotter E, Sudkamp NP, Oberst M. Computer-navigated iliosacral screw insertion reduces malposition rate and radiation exposure. Clin Orthop Relat Res. 2009 Jul;467(7):1833-8. doi: 10.1007/s11999-008-0632-6. Epub 2008 Nov 26.
- Results publication: PubMed 33590317Hoffmann MF, Yilmaz E, Norvel DC, Schildhauer TA. Navigated iliac screw placement may reduce radiation and OR time in lumbopelvic fixation of unstable complex sacral fractures. Eur J Orthop Surg Traumatol. 2021 Oct;31(7):1427-1433. doi: 10.1007/s00590-021-02892-7. Epub 2021 Feb 16.
- Results publication: PubMed 33811488Gericke L, Fritz A, Osterhoff G, Josten C, Pieroh P, Hoch A. Percutaneous operative treatment of fragility fractures of the pelvis may not increase the general rate of complications compared to non-operative treatment. Eur J Trauma Emerg Surg. 2022 Oct;48(5):3729-3735. doi: 10.1007/s00068-021-01660-w. Epub 2021 Apr 3.
- Results publication: PubMed 41054280Ran D, Wang C. Efficacy and safety of different fixation methods for unstable anterior pelvic ring fractures: a Bayesian network meta-analysis. Ann Med. 2025 Dec;57(1):2563000. doi: 10.1080/07853890.2025.2563000. Epub 2025 Oct 6.
- Results publication: PubMed 36119388Lu S, Liu F, Xu W, Zhou X, Li L, Zhou D, Li Q, Dong J. Management of Open Tile C Pelvic Fractures and Their Outcomes: A Retrospective Study of 30 Cases. Ther Clin Risk Manag. 2022 Sep 10;18:929-937. doi: 10.2147/TCRM.S378740. eCollection 2022.
- Results publication: PubMed 37533441de Ridder VA, Whiting PS, Balogh ZJ, Mir HR, Schultz BJ, Routt MC. Pelvic ring injuries: recent advances in diagnosis and treatment. OTA Int. 2023 Jun 16;6(3 Suppl):e261. doi: 10.1097/OI9.0000000000000261. eCollection 2023 Jun.
- Results publication: PubMed 38962370Tienpratarn W, Nakpipat N, Yuksen C, Wongwaisayawan S, Phootothum Y, Jaiboon S. Clinical Associated Factors of Tile B/C Type of Pelvic Ring Fractures; a Retrospective Cross-sectional study. Arch Acad Emerg Med. 2024 May 12;12(1):e49. doi: 10.22037/aaem.v12i1.2243. eCollection 2024.
- Results publication: PubMed 41053562Ding H, Wang W, Sun W, Liu L, Huang M, Han D, Lu Y, Zhou J, Pan J. Clinical characteristics and mortality risk factors in polytrauma patients with pelvic fractures: a retrospective study based on an integrated multidisciplinary treatment approach. Int J Emerg Med. 2025 Oct 6;18(1):192. doi: 10.1186/s12245-025-00990-5.
- Results publication: PubMed 40710040Ohla J, Walus P, Wicinski M, Malkowski B, Turon B, Jablonski A, Gawryjolek M, Kellett K, Zabrzynski J. Pelvic Fractures in Adults and the Importance of Associated Injuries-A Current Multi-Disciplinary Approach. Clin Pract. 2025 Jul 11;15(7):130. doi: 10.3390/clinpract15070130.
- Results publication: PubMed 29250500Hermans E, Biert J, Edwards MJR. Epidemiology of Pelvic Ring Fractures in a Level 1 Trauma Center in the Netherlands. Hip Pelvis. 2017 Dec;29(4):253-261. doi: 10.5371/hp.2017.29.4.253. Epub 2017 Dec 1.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Robot Assisted Minimally Invasive Fixation in people with Pelvic Fracture, run by Junbo Liang.
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 7 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: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Junbo Liang, Dr. (0576-85190463, liangjb@enzemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) for Pain (time frame: At 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 12 hours, day 1, day 2, day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment). 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 NCT07624942, which also lists 11 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 3 Jun 2026.