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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2015 by Andrew Kwek Boon Eu, Changi General Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02088385
First Posted: March 14, 2014
Last Update Posted: February 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Andrew Kwek Boon Eu, Changi General Hospital
  Purpose
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 Intervention Phase
Bleeding Peptic Ulcers Device: Hemospray Device: Combined Conventional Technique Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Andrew Kwek Boon Eu, Changi General Hospital:

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


Estimated Enrollment: 20
Study Start Date: November 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

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


Contacts
Contact: Andrew Kwek, MBBS andrew_kwek@cgh.com.sg

Locations
Singapore
Changi General Hospital Recruiting
Singapore, Singapore
Contact: Andrew Kwek, MBBS       andrew_kwek@cgh.com.sg   
Sponsors and Collaborators
Changi General Hospital
Investigators
Principal Investigator: Andrew Kwek, MBBS Changi General Hospital
  More Information

Responsible Party: Andrew Kwek Boon Eu, Consultant, Changi General Hospital
ClinicalTrials.gov Identifier: NCT02088385     History of Changes
Other Study ID Numbers: 2013/575/E
First Submitted: March 13, 2014
First Posted: March 14, 2014
Last Update Posted: February 5, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Ulcer
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage
Hemostatics
Coagulants