Purastat Prevention Delayed Bleeding Duodenum
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ClinicalTrials.gov Identifier: NCT04629768 |
Recruitment Status :
Recruiting
First Posted : November 16, 2020
Last Update Posted : November 16, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lesion; Duodenum | Device: PuraStat | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 59 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Study to Evaluate the Effectiveness of Purastat® in the Prevention of Delayed Bleeding After EMR of Non-ampullary Duodenal Lesions |
Actual Study Start Date : | October 2, 2020 |
Estimated Primary Completion Date : | October 2022 |
Estimated Study Completion Date : | September 2023 |
Arm | Intervention/treatment |
---|---|
Duodenal EMR + PuraStat
PuraStat will be applied to the defect after duodenal EMR of the lesion
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Device: PuraStat
Purastat is applied to the EMR defect |
- The presence of active bleeding or high risk stigma of bleeding [ Time Frame: 1 day after EMR ]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
- The presence of clinical signs of delayed bleeding [ Time Frame: 'During hospital stay, assessed up to 10 days' and '30 days after EMR' ]The presence of hematemesis, melena, hemoglobin/hematocrit drop, hypotension or shock will be observed in the patients that had duodenal EMR with PuraStat application.
- The presence of other adverse events [ Time Frame: 'During hospital stay, assessed up to 10 days' and '30 days after EMR' ]The presence of adverse events like perforation, severe pain, fever… will be observed in the patients that had duodenal EMR with Purastat application
- The feasibility of PuraStat application: Amount [ Time Frame: During EMR procedure ]The amount of PuraStat will be investigated: Volume in mL
- The feasibility of PuraStat application: Ease [ Time Frame: During EMR procedure ]The ease of application will be investigated: Questionnaire will be answered by the endoscopist.
- The feasibility of Purastat application: Coverage [ Time Frame: During EGD procedure ]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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Duodenal non-ampullary mucosal lesion ≥ 10 mm
- ≥ 18y of age
- Informed consent obtained
Exclusion Criteria:
- Ampulloma
- Submucosal lesion
- Lesion < 10 mm
- >1 lesion resected
- Active use of anticoagulant or antithrombotic medication other than aspirin
- Known clotting disorder
- Inability to give informed consent
- < 18y of age

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04629768
Contact: Raf Bisschops | +3216342161 | raf.bisschops@uzleuven.be | |
Contact: Ingrid Demedts | +3216345518 | ingrid.demedts@uzleuven.be |
Belgium | |
University Hospitals Leuven | Recruiting |
Leuven, Belgium, 3000 | |
Contact: Raf Bisschops, MD PhD +3216342161 raf.bisschops@uzleuven.be | |
Contact: Ingrid Demedts, MD PhD +3216345518 ingrid.demedts@uzleuven.be | |
Sub-Investigator: Raf Bisschops, MD PhD | |
Principal Investigator: Ingrid Demedts, MD PhD |
Principal Investigator: | Ingrid Demedts | UZ Leuven |
Responsible Party: | Prof. Dr. Raf Bisschops, Clinical professor, Universitaire Ziekenhuizen KU Leuven |
ClinicalTrials.gov Identifier: | NCT04629768 |
Other Study ID Numbers: |
S63851 |
First Posted: | November 16, 2020 Key Record Dates |
Last Update Posted: | November 16, 2020 |
Last Verified: | November 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Purastat EMR duodenum |
Hemorrhage Pathologic Processes |