Removable Titanium Clip Treatment for Acute Variceal Hemorrhage from the Gastric Fundus

March 7, 2025 updated by: Shupei Li

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Removable Titanium Clip
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The patient and their family agree to and sign the relevant informed consent form.
  2. Diagnosed with cirrhosis based on clinical manifestations, laboratory tests, imaging findings, or pathological examinations.
  3. History of symptoms related to variceal upper gastrointestinal bleeding, such as hematemesis, melena, or rectal bleeding.
  4. Patients confirmed by endoscopy to have bleeding from ruptured gastric varices.
  5. Patients who are hemodynamically stable before or after initial fluid resuscitation.
  6. Aged 18 to 75 years.

Exclusion Criteria:

  1. Those with concomitant bleeding from ruptured esophageal varices.
  2. A history of gastrointestinal-related surgical procedures.
  3. Individuals with altered consciousness who are difficult to treat.
  4. Those with concomitant malignant tumors.
  5. Individuals with serious diseases involving the heart, brain, lungs, or kidneys.
  6. Pregnant and breastfeeding women.
  7. Those with contraindications to relevant treatments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: a removable titanium clip
Device: a removable titanium clip
The removable titanium clip is a new type of titanium clip that offers advantages such as easy operation and convenient disassembly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 5 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shupei Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2024

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

December 10, 2024

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DZQH-KYLLFS-24-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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