An interventional study of Hemospray and Combined Conventional Technique in Bleeding Peptic Ulcers, sponsored by Changi General Hospital. Completed at 1 site in Singapore. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-08-29.
Sponsored by Changi General Hospital · Not applicable, Interventional, and Treatment
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.
193 studies on the registry are indexed under Peptic Ulcer; 31 are open to participants now.
This study's enrollment of 20 is below the median of 150 across 142 interventional studies indexed under Peptic Ulcer.
Browse Peptic Ulcer studies →Changi General Hospital is the lead sponsor of 98 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), an adsorptive nanopowder hemostatic agent
Device: Hemospray
Standard dual therapy with saline adrenaline injection and hemoclip / heater probe application
Device: Combined Conventional Technique
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)
Time frame: 4 weeks
Initial Hemostasis Rate
Endoscopically verified cessation of bleeding for at least 5 minutes after treatment.
Time frame: Within first endoscopy session
| Milestone | Hemospray | Combined Conventional Technique |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
* 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)
| Participants | Hemospray | Combined Conventional Technique |
|---|---|---|
| Re-bleeding Within 4 Weeks | 3 | 1 |
Endoscopically verified cessation of bleeding for at least 5 minutes after treatment.
| Participants | Hemospray | Combined Conventional Technique |
|---|---|---|
| Initial Hemostasis Rate | 9 | 10 |
Collected over 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hemospray | 1/10 (10%) | 2/10 (20%) | 0/10 (0%) |
| Combined Conventional Technique | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Event | Hemospray | Combined Conventional Technique |
|---|---|---|
| DeathRespiratory, thoracic and mediastinal disorders | 1/10 | 0/10 |
| Acute Myocardial InfarctionCardiac disorders | 1/10 | 0/10 |
| Age, Categorical(Participants) | Hemospray | Combined Conventional Technique | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 3 | 5 |
| >=65 years | 8 | 7 | 15 |
| Age, Continuous(years) | Hemospray | Combined Conventional Technique | Total |
|---|---|---|---|
| Mean | 67.9 ± 18.4 | 72.1 ± 11.4 | 70 ± 14.9 |
| Sex: Female, Male(Participants) | Hemospray | Combined Conventional Technique | Total |
|---|---|---|---|
| Female | 1 | 3 | 4 |
| Male | 9 | 7 | 16 |
| Region of Enrollment(participants) | Hemospray | Combined Conventional Technique | Total |
|---|---|---|---|
| Singapore | 10 | 10 | 20 |
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Changi General Hospital