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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Changi General Hospital
Sponsor:
Information provided by (Responsible Party):
Andrew Kwek Boon Eu, Changi General Hospital
ClinicalTrials.gov Identifier:
NCT02088385
First received: March 13, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Changi General Hospital:

Primary Outcome Measures:
  • Re-bleeding within 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    Endoscopically verified cessation of bleeding for at least 5 minutes after treatment.


Estimated Enrollment: 20
Study Start Date: November 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Andrew Kwek Boon Eu, Consultant, Changi General Hospital
ClinicalTrials.gov Identifier: NCT02088385     History of Changes
Other Study ID Numbers: 2013/575/E
Study First Received: March 13, 2014
Last Updated: March 13, 2014
Health Authority: Singapore: Health Sciences Authority

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

ClinicalTrials.gov processed this record on September 18, 2014