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Completed

NCT Number: NCT02088385

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

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.

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Key information

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changi General Hospital

Singapore

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemospray

Device

Combined Conventional Technique

Device

Primary outcomes

  1. Re-bleeding Within 4 Weeks

    Time frame: 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)

Secondary outcomes

  1. Initial Hemostasis Rate

    Time frame: Within first endoscopy session

    Endoscopically verified cessation of bleeding for at least 5 minutes after treatment.

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 14, 2014
Registry last updated
Aug 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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