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

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ClinicalTrials.gov Identifier: NCT02088385
Recruitment Status : Completed
First Posted : March 14, 2014
Results First Posted : August 29, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew Kwek Boon Eu, Changi General Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Bleeding Peptic Ulcers Device: Hemospray Device: Combined Conventional Technique Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of a Randomized Controlled Trial Comparing Hemospray Versus the Combined Conventional Technique for Endoscopic Hemostasis of Bleeding Peptic Ulcers
Study Start Date : November 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Initial Hemostasis Rate [ Time Frame: Within first endoscopy session ]
    Endoscopically verified cessation of bleeding for at least 5 minutes after treatment.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088385


Locations
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Singapore
Changi General Hospital
Singapore, Singapore
Sponsors and Collaborators
Changi General Hospital
Investigators
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Principal Investigator: Andrew Kwek, MBBS Changi General Hospital
More Information
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Responsible Party: Andrew Kwek Boon Eu, Consultant, Changi General Hospital
ClinicalTrials.gov Identifier: NCT02088385    
Other Study ID Numbers: 2013/575/E
First Posted: March 14, 2014    Key Record Dates
Results First Posted: August 29, 2019
Last Update Posted: August 29, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Peptic Ulcer
Peptic Ulcer Hemorrhage
Ulcer
Hemorrhage
Pathologic Processes
Duodenal Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage