The goal of this investigation is to show that Hemospray is effective in achieving initial hemostasis rates equivalent to standard of care treatment and a decreased rate of further bleed when compared to standard of care up to 72 hours after…
ID
Source
Brief title
Condition
- Gastrointestinal haemorrhages NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary effectiveness endpoint: Proportion of patients with further bleeds
within 72hours
of the index procedure
Secondary outcome
• Proportion of patients with hemostasis at conclusion of index procedure
(initial hemostasis)
• Clinical success: initial hemostasis and no SAE within 72 hours of index
procedure
• Early recurrent bleed: recurrent bleeding within 72 hours of the application
of Hemospray
• Late recurrent bleed: recurrent bleed occurring 72 hours - 30 days
• The incidence of serious adverse GI event within 30 days of the application
of Hemospray
• Incidence of serious adverse events within 30 days of the application of
Hemospray
• Incidence of mortality at 30 days
Background summary
Upper GI anatomy can be tortuous resulting in difficulty in applying current
standard therapies which, with exception of argon plasma coagulation (APC),
require direct tissue contact at the site of bleeding. Furthermore, the acidic
environment of the stomach and duodenum present a challenge to the maintenance
of hemostasis. Even in the presence of proton pump inhibitors (PPI) and/or
histamine H2 receptor antagonists (H2 RA), naturally occurring clot can be
broken down resulting in loss of longer term hemostasis. Therefore, spurting
and oozing peptic ulcers may be considered the worst case scenario of GI
bleeding due the challenging anatomy and environment. Evidence of device
effectiveness in peptic ulcers with a high risk of recurrent bleeding (e.g.,
spurting, oozing ulcers) will be used to support the use of the Hemospray
material in the GI tract.
A prospective, single arm, pilot clinical study of 20 patients was conducted at
a single center in Hong Kong. The study was designed to evaluate the safety and
effectiveness of Hemospray for hemostasis of active peptic ulcer bleeding
(spurting or oozing).Twenty patients were recruited in this study (18 males, 2
females, mean age 60.2 years). Acute hemostasis was achieved in 95% (19/20) of
patients; 1 patient in whom acute hemostasis was not achieved was treated with
standard of care. After the failure of 3 subsequent attempts to gain hemostasis
using epinephrine injection and hemostasis clips, the patient was referred for
angiography. During angiopraphy, a pseudoaneurysm requiring arterial
embolization was identified at the bleeding site. Of the 19 patients with
successful acute hemostasis, sustained hemostasis was achieved in 17 (89.5%)
patients through 72 hours. Two patients met the study definition of recurrent
bleeding. One patient was found to have a drop in hemoglobin greater than 2
g/dL on Day 3 despite blood transfusion. Repeat endoscopy at 72 hours revealed
no active bleeding. No further treatment was applied and the patient recovered
uneventfully. The second patient developed tachycardia and hypotension with a
drop in hemoglobin >2 g/dL on Day 2. Repeat endoscopy showed no active
bleeding. In both of these patients, no active bleeding was observed at the
treated lesion sites at the 72-hour second-look endoscopy indicating that the
Hemospray maintained hemostasis at the treatment site. There was no mortality,
no major adverse events and no treatment or procedure related serious adverse
events reported during the 30-day follow-up. The results from this pilot study
indicated that Hemospray is safe and effective for use in the GI tract.
Study objective
The goal of this investigation is to show that Hemospray is effective in
achieving initial hemostasis rates equivalent to standard of care treatment and
a decreased rate of further bleed when compared to standard of care up to 72
hours after treatment. In addition, this investigation will collect data
regarding the ease of application and time to hemostasis which may show
clinical advantage in the use of this single modality treatment.
Study design
This prospective, single-arm, open label study will evaluate the effectiveness
of Hemospray for the hemostasis in patients with nonvariceal GI bleeding. The
data collection may include up to 80 patients at up to 15 sites in the US,
Europe, Canada and Hong Kong. The Hemospray treatment will be compared to a
historical control using a performance goal based on a thorough literature
review.
Intervention
Upon endoscopic verification of a bleeding peptic ulcer, Hemospray powder will
be endoscopically applied to the bleeding ulcer until hemostasis is achieved,
or until 3 syringes or 2 applications are exhausted. If hemostasis is not
achieved using Hemospray, standard treatment will be used by the physician.
Study burden and risks
Despite being in contact with breached or compromised tissues, the Hemospray
material appears to have no risk of systemic toxicity and showed no evidence
irritation/intracutaneous reactivity when tested according to ISO10993-10
(NAMSA summary report).
There are risks including clinical or procedural complications that may develop
as a result of endoscopic treatment with Hemospray. Endoscopic procedures are
generally recognized as safe, but have known risks including but not limited
to: perforation, hemorrhage, aspiration, fever, infection, allergic reaction to
medication, hypotension, respiratory depression or arrest, and cardiac
arrhythmia or arrest. Applying Hemospray during an endoscopic procedure adds
no additional risk to the endoscopic procedure. There are also clinical
complications that may develop as a result of treatment with Hemospray.
Although these risks are considered very unlikely, those classified as serious
adverse GI events include: arterial embolization of the Hemospray and impaction
of the Hemospray material in the colon.
Sandet 6
Bjaeverskov 4632
DK
Sandet 6
Bjaeverskov 4632
DK
Listed location countries
Age
Inclusion criteria
Patients require hemostasis for nonvariceal GI bleeding. Specifically, patients with actively bleeding peptic ulcer with a Forrest score of 1a or 1b (spurting or oozing).
Exclusion criteria
• Patient is < 18 years of age
• Patient is unable or unwilling to provide written informed consent
• Patient is on a thienopyridine class antiplatelet agent (e.g., Clopidogrel, Ticlopidine and Prasugrel) which cannot be discontinued for the procedure and 72 hours post procedure
• Patient is pregnant or lactating
• Patient has uncorrected coagulopathy as determined by the physician
• Patient is contraindicated to undergo endoscopy
• Altered post surgical anatomy of the stomach (e.g., bariatric surgery)
• Patient has a previously placed intrahepatic portosystemic shunt
• Patient has an ASA class 5 (See Appendix D)
• Patients with gastrointestinal fistula (e.g., trachea-esophageal fistula, bronchio-esophageal fistula)
• Patient with suspected gastrointestinal perforation
• Patient has an INR > 2.5
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01306864 |
| CCMO | NL37082.078.11 |