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

C

Changi General Hospital

Status

Completed

Conditions

Bleeding Peptic Ulcers

Treatments

Device: Hemospray
Device: Combined Conventional Technique

Study type

Interventional

Funder types

Other

Identifiers

NCT02088385
2013/575/E

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

21 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Hemospray
Experimental group
Description:
Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), an adsorptive nanopowder hemostatic agent
Treatment:
Device: Hemospray
Combined Conventional Technique
Active Comparator group
Description:
Standard dual therapy with saline adrenaline injection and hemoclip / heater probe application
Treatment:
Device: Combined Conventional Technique

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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