An interventional study of PuraStat in Lesion; Duodenum, sponsored by Prof. Dr. Raf Bisschops. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-16.
Sponsored by Prof. Dr. Raf Bisschops · Not applicable, Interventional, and Prevention
PuraStat is a viscous solution of synthetic peptides that provides a physical barrier to facilitate hemostasis. It is indicated for haemostasis in a variety of surgical indications. In this study the efficacy of PuraStat in reducing delayed bleeding following duodenal endoscopic mucosal resection (EMR) will be assessed. PuraStat will be applied to the EMR defect after the resection. The presence of active bleeding or high risk stigma of bleeding will be observed on an esophagogastroduodenoscopy (EGD) performed 1 day after the duodenal EMR. Furthermore the presence of clinical signs of delayed bleeding, other adverse events and the feasibility of PuraStat application will be assessed.
This is the only study on the registry with Prof. Dr. Raf Bisschops as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
PuraStat will be applied to the defect after duodenal EMR of the lesion
Device: PuraStat
Purastat is applied to the EMR defect
The presence of active bleeding or high risk stigma of bleeding
On an EGD, performed the day after the duodenal EMR with PuraStat application, the presence of active bleeding or the presence of visible vessels after removal of a blood clot will be observed
Time frame: 1 day after EMR
The presence of clinical signs of delayed bleeding
The presence of hematemesis, melena, hemoglobin/hematocrit drop, hypotension or shock will be observed in the patients that had duodenal EMR with PuraStat application.
Time frame: 'During hospital stay, assessed up to 10 days' and '30 days after EMR'
The presence of other adverse events
The presence of adverse events like perforation, severe pain, fever... will be observed in the patients that had duodenal EMR with Purastat application
Time frame: 'During hospital stay, assessed up to 10 days' and '30 days after EMR'
The feasibility of PuraStat application: Amount
The amount of PuraStat will be investigated: Volume in mL
Time frame: During EMR procedure
The feasibility of PuraStat application: Ease
The ease of application will be investigated: Questionnaire will be answered by the endoscopist.
Time frame: During EMR procedure
The feasibility of Purastat application: Coverage
Is PuraStat covering the resection defect the day after the EMR? This will be investigated by questionnaire that will be answered by the endoscopist who performs the EGD
Time frame: During EGD procedure
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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