Hemospray Versus the Combined Conventional Technique for Endoscopic Hemostasis of Bleeding Peptic Ulcers : A Pilot Study

Bleeding Peptic Ulcers Clinical Trial

Official title:

Pilot Study of a Randomized Controlled Trial Comparing Hemospray Versus the Combined Conventional Technique for Endoscopic Hemostasis of Bleeding Peptic Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088385
• Other study ID #: 2013/575/E
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: March 2015

Study information

• Verified date: July 2019
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), a new adsorptive nanopowder hemostatic agent for endoscopic treatment of high-risk bleeding peptic ulcers, provides significant ease of administration compared to the combined conventional technique of saline-adrenaline injection with mechanical clip or heater probe applications. The Hemospray powder is easily applied on ulcers at difficult endoscopic positions and ulcers with fibrotic bases, where the combined conventional technique has limited efficacy. Building up on preliminary work from small single-arm studies, the investigators aim to establish the efficacy and safety of Hemospray in treating bleeding peptic ulcers in comparison with the combined conventional technique. The investigators propose a pilot study to establish our centre's feasibility of performing a prospective, randomized, parallel group trial, which compares the efficacy of Hemospray with the combined conventional technique, in the endoscopic treatment of high-risk bleeding peptic ulcers. Patients with high-risk bleeding peptic ulcers will be treated with Hemospray to determine its initial hemostasis rate (defined as endoscopically verified cessation of bleeding for at least 5 minutes after endoscopic treatment), rebleeding rate (recurrent hemorrhage during a 4-week period following the initial hemostasis) and its safety profile.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

Inclusion Criteria:

• Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB)

Exclusion Criteria:

• Patients younger than 21 years of age

• Refusal to participate in study

• Contraindicated for endoscopy

• Pregnant or lactating patients

• Bleeding secondary to non-peptic ulcer source

• Patients requiring mechanical ventilation

• Patients with acute coronary syndrome

Related Conditions & MeSH terms

• Bleeding Peptic Ulcers
• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Intervention

Device:
• Hemospray

• Combined Conventional Technique

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-bleeding Within 4 Weeks	drop in hemoglobin of at least 2 g/dl, associated with overt signs of GI bleed (melena, and/or hematemesis); fresh blood hematemesis; melena with a hemodynamic instability (pulse rate > 100/min, systolic blood pressure < 90 mm Hg)	4 weeks
Secondary	Initial Hemostasis Rate	Endoscopically verified cessation of bleeding for at least 5 minutes after treatment.	Within first endoscopy session