Secondary HypersplenismNCT06292715
A Single-Arm Clinical Trial of Percutaneous Splenic Ablation Combined With Splenic Artery Occlusion for Secondary Hypersplenism.
A study testing microwave ablation of the spleen and Splenic artery balloon implantation in people with Secondary Hypersplenism, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study assesses the effectiveness of microwave ablation of the spleen in conjunction with splenic artery occlusion for treating secondary hypersplenism. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Secondary Hypersplenism
- What is being tested?
- microwave ablation of the spleen and Splenic artery balloon implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2024to 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. written informed consent signed prior to enrolment 2. age > 18 years, both sexes 3.Patients with severe hypersplenism secondary to cirrhosis with clinical diagnosis, White blood cells <3×109/L, and/or platelet <50×109/L 4.Patients who have been repeatedly given drugs to raise white blood cells and platelets in clinical practice have poor effect 5.Mental problems such as clinical symptoms or anxiety in patients require interventional treatment for hypersplenism
Who cannot join
- Patients with any of the following are not eligible for enrollment in this study
- Coagulopathy or other blood disorders
- Recent use of anticoagulant drugs
- Severe hypertension and cardiac insufficiency
- Bone marrow aspiration results showed bone marrow suppression
- Combined with other spleen malignant diseases
Show all 9Show fewer
- Severe skin infection at the puncture site
- Participated in other clinical studies within 2 months prior to the start of the study
- Patient or his/her authorized person is unwilling to sign a written informed consent form or unwilling to comply with the study protocol
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
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Huikai Li, +862223340123 ext. 3091, lihuikai@tjmuch.com
About this study
Official title: A Single-Arm Clinical Study Evaluating Microwave Ablation of the Spleen Combined With Splenic Artery Occlusion for Secondary Hypersplenism Treatment
This study assesses the effectiveness of microwave ablation of the spleen in conjunction with splenic artery occlusion for treating secondary hypersplenism.
Read the detailed description
This open-label, single-arm, single-center clinical trial investigates the combined approach of microwave ablation of the spleen and splenic artery occlusion for managing secondary hypersplenism.
- Conditions
- Secondary Hypersplenism
- Being tested
- microwave ablation of the spleen, Splenic artery balloon implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microwave ablation of the spleenProcedure or surgery
Ultrasound-guided percutaneous puncture for splenic ablation treatment
Splenic artery balloon implantationOther
Splenic artery balloon implantation
| Study group | Role | What they receive |
|---|---|---|
| microwave ablation of the spleen combined with splenic artery occlusion | Experimental | The ablation puncture needle is percutaneously punctured into the spleen under ultrasound guidance, and the ablation method of one needle and multi-point method and needle insertion and pulling is mostly used Receives: Procedure: microwave ablation of the spleen; Other: Splenic artery balloon implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic changes in platelet and white blood cell counts in routine blood tests
Platelet and WBC count changes on CBC
Measured: Up to 1 year
Hepatic artery blood flow velocity
Hepatic artery blood flow velocity
Measured: Up to 1 year
Routine blood test
Platelet count
Measured: Up to 1 year
Adverse Events
Adverse Events
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start20 Jan 2024
- Primary completion31 Dec 2025
- 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 Secondary HypersplenismStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- WEI LU, PhD, Principal investigator, Tianjin Cancer Hospital Airport Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292715
- Sponsor's protocol ID
- Microwave Ablation01
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Clinical Study Evaluating Microwave Ablation of the Spleen Combined With Splenic Artery Occlusion for Secondary Hypersplenism Treatment
- ClinicalTrials.gov ID
- NCT06292715
- Acronym / sponsor ID
- Microwave Ablation01
- Conditions
- Secondary Hypersplenism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Mar 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.
This study assesses the effectiveness of microwave ablation of the spleen in conjunction with splenic artery occlusion for treating secondary hypersplenism.
Detailed description
This open-label, single-arm, single-center clinical trial investigates the combined approach of microwave ablation of the spleen and splenic artery occlusion for managing secondary hypersplenism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| microwave ablation of the spleen combined with splenic artery occlusion | Experimental | Procedure: microwave ablation of the spleen, Other: Splenic artery balloon implantationThe ablation puncture needle is percutaneously punctured into the spleen under ultrasound guidance, and the ablation method of one needle and multi-point method and needle insertion and pulling is mostly used |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. written informed consent signed prior to enrolment 2. age > 18 years, both sexes 3.Patients with severe hypersplenism secondary to cirrhosis with clinical diagnosis, White blood cells <3×109/L, and/or platelet <50×109/L 4.Patients who have been repeatedly given drugs to raise white blood cells and platelets in clinical practice have poor effect 5.Mental problems such as clinical symptoms or anxiety in patients require interventional treatment for hypersplenism
Key exclusion criteria (9 listed)
- Patients with any of the following are not eligible for enrollment in this study
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 |
|---|---|---|
| microwave ablation of the spleenUltrasound-guided percutaneous puncture for splenic ablation treatment | Procedure or surgery | microwave ablation of the spleen combined with splenic artery occlusion |
| Splenic artery balloon implantationSplenic artery balloon implantation | Other | microwave ablation of the spleen combined with splenic artery occlusion |
Primary outcome
Dynamic changes in platelet and white blood cell counts in routine blood tests
Time frame: Up to 1 year
Platelet and WBC count changes on CBC
Hepatic artery blood flow velocity
Time frame: Up to 1 year
Hepatic artery blood flow velocity
Routine blood test
Time frame: Up to 1 year
Platelet count
Adverse Events
Time frame: Up to 1 year
Adverse Events
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 16 Jul 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.
WEI LU, PhD principal investigator
Tianjin Cancer Hospital Airport Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microwave ablation of the spleen and Splenic artery balloon implantation in people with Secondary Hypersplenism, run by Tianjin Medical University Cancer Institute and Hospital 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 1 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 16 Jul 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 WEI LU, PhD (13820476460, luwei1966@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic changes in platelet and white blood cell counts in routine blood tests (time frame: Up to 1 year). The study lists 4 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 16 Jul 2026.