N/A
N=20
Hemospray Versus the Combined Conventional Technique for Endoscopic Hemostasis of Bleeding Peptic Ulcers : A Pilot Study
Bleeding Peptic Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT02088385 ↗Enrolled (actual)
20
Serious AEs
10.0%
Results posted
Aug 2019
Primary outcome: Primary: Re-bleeding Within 4 Weeks — 3; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hemospray (Device); Combined Conventional Technique (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Changi General Hospital
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Re-bleeding Within 4 Weeks |
3; 1 | — |
| SECONDARY Initial Hemostasis Rate |
9; 10 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02088385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.