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

NCT02088385 | Completed Results

• 1 other identifier: 2013/575/E
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding Peptic Ulcers

Outcome Measures

Primary Outcomes (1)

• Re-bleeding Within 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)

  4 weeks

Secondary Outcomes (1)

• Initial Hemostasis Rate

  Within first endoscopy session

Study Arms (2)

Hemospray

EXPERIMENTAL

Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), an adsorptive nanopowder hemostatic agent

Device: Hemospray

Combined Conventional Technique

ACTIVE COMPARATOR

Standard dual therapy with saline adrenaline injection and hemoclip / heater probe application

Device: Combined Conventional Technique

Interventions

Hemospray DEVICE

Hemospray

Combined Conventional Technique DEVICE

Combined Conventional Technique

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB)

You may not qualify if:

• 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

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, Singapore

Location

Results Point of Contact

• Title: Dr Andrew Kwek Boon Eu
• Organization: Changi General Hospital

andrew_kwek@cgh.com.sg

6788 8833

Study Officials

• Andrew Kwek, MBBS

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 14, 2014
• Study Start: November 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 29, 2019
• Results First Posted: August 29, 2019

Record last verified: 2019-07

Locations

SG (1)