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Clinical evaluation of the safety and performance of microwave coagulation using the HS1 Instrument for actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients receiving microwave therapy using the HS1 Instrument | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microwave coagulation using HS1 Instrument | Device | Microwave therapy at 5.8 GHz |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effective coagulation of of actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract. | Primary haemostasis at day 0 using microwave coagulation of active bleeding or pre-coagulation of exposed vessels. | Perioperative |
| Measure | Description | Time Frame |
|---|---|---|
| Identification and incidence of intra-procedural complications | Day 0 | |
| Identification and incidence of post-procedural complications | At 24-72 hours, 1 week and 4 weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire assessment of device injection features | Endoscopist assessment of injection functionality (questionnaire) | Perioperative |
| Questionnaire assessment of device adhesion characteristics | Endoscopist assessment of tissue sticking (questionnaire) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| dan crocker | Contact | +44 1291 606005 | dan.crocker@creomedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Kent Hospitals University Nhs Foundation Trust | Canterbury | Kent | United Kingdom |
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| Change in Glasgow-Blatchford score |
The Glasgow-Blatchford score will be recorded prior to and after microwave intervention |
| Day 0 for initial screen and then 24-72 hours post-procedure for second score. |
| Perioperative |