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

NCT06736314 | Recruiting

• 1 other identifier: DZQH-KYLLFS-24-26
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Variceal Bleeding

Keywords

a removable titanium clip

Outcome Measures

Primary Outcomes (1)

• 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.

  within 5 days after treatment

Study Arms (1)

a removable titanium clip

EXPERIMENTAL

Device: a removable titanium clip

Interventions

a removable titanium clip DEVICE

The removable titanium clip is a new type of titanium clip that offers advantages such as easy operation and convenient disassembly.

a removable titanium clip

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shupei Li: lead

Study Sites (1)

Removable Titanium Clip

Nanjing, Jiangsu, 210000, China

RECRUITING

Central Study Contacts

Changqing Sun

CONTACT

18851675250; 18851675250@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: student

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 16, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: March 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)