NCT06393907

Hemostatic Forceps vs. Bipolar Electrocautery Probes for High-Risk Bleeding Gastroduodenal Ulcers

A Randomized Trial of Hemostatic Forceps Versus Bipolar Electrocautery Probes for High-Risk Bleeding Gastroduodenal Ulcers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patient with high risk bleeding gastroduodenal ulcers.

Detailed description

This is a prospective randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patients with high-risk bleeding gastroduodenal ulcers. The primary outcome is comparing the hemostatic rates of the devices. Secondary outcomes are rebleeding rate at 7 and 30 days after index intervention, survival rate after intervention, procedure time for achieving hemostasis, number of units of infused blood, duration of hospitalization, and complications.

Conditions

• Gastroduodenal Ulcer

Interventions

Type	Name	Description
DEVICE	Hemostatic Forceps	The experimental device will be used for control bleeding in high risk gastroduodenal ulcers.
DEVICE	Bipolar Electrocautery Probes	The active comparator devices will be used for control bleeding in high risk gastroduodenal ulcers.

Timeline

• Start date: 2024-03-26
• Primary completion: 2026-03-26
• Completion: 2026-04-26
• First posted: 2024-05-01
• Last updated: 2024-05-01

Locations

1 site across 1 country: Thailand

Regulatory

• FDA-regulated device study