Gastric Variceal BleedingNCT06736314
Removable Titanium Clip Treatment for Acute Variceal Hemorrhage from the Gastric Fundus
A study testing a removable titanium clip in people with Gastric Variceal Bleeding, run by Shupei Li at 1 site in China.
Trial summary
Removable Titanium Clip Treatment for Acute Variceal Hemorrhage from the Gastric Fundus Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Variceal Bleeding
- What is being tested?
- a removable titanium clip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2024to 30 Nov 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient and their family agree to and sign the relevant informed consent form.
- Diagnosed with cirrhosis based on clinical manifestations, laboratory tests, imaging findings, or pathological examinations.
- History of symptoms related to variceal upper gastrointestinal bleeding, such as hematemesis, melena, or rectal bleeding.
- Patients confirmed by endoscopy to have bleeding from ruptured gastric varices.
- Patients who are hemodynamically stable before or after initial fluid resuscitation.
- Aged 18 to 75 years.
Who cannot join
- Those with concomitant bleeding from ruptured esophageal varices.
- A history of gastrointestinal-related surgical procedures.
- Individuals with altered consciousness who are difficult to treat.
- Those with concomitant malignant tumors.
- Individuals with serious diseases involving the heart, brain, lungs, or kidneys.
- Pregnant and breastfeeding women.
- Those with contraindications to relevant treatments.
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
Removable Titanium Clip
Nanjing, Jiangsu, 210000
Changqing Sun, 18851675250, 18851675250@163.com
About this study
Official title: A Single-center Exploratory Clinical Study on the Use of Removable Titanium Clips for the Treatment of Acute Variceal Hemorrhage from the Gastric Fundus
Removable Titanium Clip Treatment for Acute Variceal Hemorrhage from the Gastric Fundus
Read the detailed description
During the procedure, a removable titanium clip was used to block the bleeding vessels, enabling rapid hemostasis. Five days later, secondary preventive measures such as ECI or TIPS were performed. The titanium clip was removed during or after the procedure, avoiding its retention in the body, which could interfere with subsequent MRI examinations and related treatments. In situations where emergency ECI or other treatments are not feasible, this method can serve as a 'temporary bridge' for the treatment of acute gastric fundal variceal hemorrhage, potentially saving the patient's life.
- Conditions
- Gastric Variceal Bleeding
- Being tested
- a removable titanium clip
- Keywords
- a removable titanium clip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a removable titanium clipDevice
The removable titanium clip is a new type of titanium clip that offers advantages such as easy operation and convenient disassembly.
| Study group | Role | What they receive |
|---|---|---|
| a removable titanium clip | Experimental | Not described Receives: Device: a removable titanium clip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding rate within 5 days after treatment
Signs of rebleeding: A clinically significant event of active bleeding after hemostasis (hematemesis, melena, or rectal bleeding; a decrease in systolic blood pressure of >20 mmHg or an increase in heart rate of >20 beats/min; a drop in hemoglobin of >30 g/L without blood transfusion). (1) Early rebleeding: Occurs within 120 hours to 6 weeks after hemostasis. (2) Delayed rebleeding: Occurs more than 6 weeks after hemostasis. Non-EVB patients are excluded.
Measured: within 5 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start20 Dec 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Variceal BleedingStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shupei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shupei Li, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736314
- Sponsor's protocol ID
- DZQH-KYLLFS-24-26
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Exploratory Clinical Study on the Use of Removable Titanium Clips for the Treatment of Acute Variceal Hemorrhage from the Gastric Fundus
- ClinicalTrials.gov ID
- NCT06736314
- Acronym / sponsor ID
- DZQH-KYLLFS-24-26
- Conditions
- Gastric Variceal Bleeding
- Keywords
- a removable titanium clip
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shupei LiUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 16 Dec 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.
Removable Titanium Clip Treatment for Acute Variceal Hemorrhage from the Gastric Fundus
Detailed description
During the procedure, a removable titanium clip was used to block the bleeding vessels, enabling rapid hemostasis. Five days later, secondary preventive measures such as ECI or TIPS were performed. The titanium clip was removed during or after the procedure, avoiding its retention in the body, which could interfere with subsequent MRI examinations and related treatments. In situations where emergency ECI or other treatments are not feasible, this method can serve as a 'temporary bridge' for the treatment of acute gastric fundal variceal hemorrhage, potentially saving the patient's life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a removable titanium clip | Experimental | Device: a removable titanium clip |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient and their family agree to and sign the relevant informed consent form.
- Diagnosed with cirrhosis based on clinical manifestations, laboratory tests, imaging findings, or pathological examinations.
- History of symptoms related to variceal upper gastrointestinal bleeding, such as hematemesis, melena, or rectal bleeding.
- Patients confirmed by endoscopy to have bleeding from ruptured gastric varices.
- Patients who are hemodynamically stable before or after initial fluid resuscitation.
Key exclusion criteria (7 listed)
- Those with concomitant bleeding from ruptured esophageal varices.
- A history of gastrointestinal-related surgical procedures.
- Individuals with altered consciousness who are difficult to treat.
- Those with concomitant malignant tumors.
- Individuals with serious diseases involving the heart, brain, lungs, or kidneys.
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 |
|---|---|---|
| a removable titanium clipThe removable titanium clip is a new type of titanium clip that offers advantages such as easy operation and convenient disassembly. | Device | a removable titanium clip |
Primary outcome
Rebleeding rate within 5 days after treatment
Time frame: within 5 days after treatment
Signs of rebleeding: A clinically significant event of active bleeding after hemostasis (hematemesis, melena, or rectal bleeding; a decrease in systolic blood pressure of >20 mmHg or an increase in heart rate of >20 beats/min; a drop in hemoglobin of >30 g/L without blood transfusion). (1) Early rebleeding: Occurs within 120 hours to 6 weeks after hemostasis. (2) Delayed rebleeding: Occurs more than 6 weeks after hemostasis. Non-EVB patients are excluded.
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 10 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a removable titanium clip in people with Gastric Variceal Bleeding, run by Shupei Li 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 6 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: looking for participants now, as of the sponsor's last update on 10 Mar 2025. 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 Changqing Sun (18851675250, 18851675250@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rebleeding rate within 5 days after treatment (time frame: within 5 days after treatment). 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 10 Mar 2025.